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A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Primary Purpose

PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ralinepag
Placebo
Sponsored by
United Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PAH focused on measuring Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years of age.
  2. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures.
  3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  4. Primary diagnosis of symptomatic PAH.
  5. Has had a right heart catheterization (RHC) performed at or within 3 years prior to Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH.
  6. Has WHO/ NYHA functional class II to IV symptoms.
  7. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator.
  8. Has a 6MWD of ≥150 meters.
  9. If taking concomitant medications that may affect the clinical manifestations of PAH (eg, calcium channel blockers, diuretics, digoxin, or L arginine supplementation, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers), must be on a stable dose for at least 30 days prior to the Baseline Visit and the dosage maintained throughout the study. The exception is that the dose of diuretics must be stable for at least the 10 days prior to Baseline.
  10. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to the 30-Day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process during the study and for 30 days after the last dose of IMP. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of IMP.

Exclusion Criteria:

  1. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline.
  2. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol.
  3. Has evidence of more than mild lung disease on pulmonary function tests performed within 180 days prior to, or during Screening.
  4. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH.
  5. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator.
  6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF is >500 msec for both males and females.
  7. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy).
  8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  9. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening.
  10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening.
  11. Hemoglobin concentration <9 g/dL at Screening.
  12. Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) for PAH at any time prior to Baseline (use in vasoreactive testing is permitted).
  13. Subjects currently on or who were treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) for >6 months or within 90 days prior to Baseline.
  14. Subject has pulmonary veno-occlusive disease.
  15. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent.
  16. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. A subject will not be excluded due to a positive drug screen caused by prescribed medications.
  17. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation.
  18. Prior participation in any study of ralinepag or participation in another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, as long as the subject can fulfill all other entry criteria and comply with all study procedures.
  19. Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
  20. Known hypersensitivity to ralinepag or any of the excipients.
  21. Life expectancy <12 months based on the Investigator's opinion.
  22. Women who are pregnant, lactating or breast-feeding.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Mayo Clinic ScottsdaleRecruiting
  • University of ArizonaRecruiting
  • UCSD Health SciencesRecruiting
  • Loma Linda University Medical Center
  • Ronald Reagan UCLA Medical CenterRecruiting
  • Kaiser Permanente Los Angeles Medical CenterRecruiting
  • Keck Hospital of USCRecruiting
  • Cedars-Sinai Medical Center
  • VA Greater Los Angeles Healthcare SystemRecruiting
  • University of California Davis Medical CenterRecruiting
  • Santa Barbara Cottage HospitalRecruiting
  • Stanford University Medical CenterRecruiting
  • LA Biomedical Research Institute Harbor-UCLA Medical Center
  • University of Colorado HospitalRecruiting
  • National Jewish HealthRecruiting
  • University of FloridaRecruiting
  • Mayo Clinic Florida
  • University of Miami
  • Central Florida Pulmonary GroupRecruiting
  • Investigational Drug Services, AdventHealth Orlando (Drug Shipment Address)Recruiting
  • Cleveland Clinic FloridaRecruiting
  • Emory University HospitalRecruiting
  • Piedmont Healthcare Pulmonary and Critical Care ResearchRecruiting
  • University of Chicago Medical CenterRecruiting
  • Indiana University School of Medicine
  • Community Hearth and Vascular Hospital
  • St. Vincent Medical Group, Inc.Recruiting
  • University of Iowa Hospitals and ClinicsRecruiting
  • Kentuckiana Pulmonary Research CenterRecruiting
  • Ochsner Medical Center
  • Chest Medicine Associates
  • University of Maryland Medical CenterRecruiting
  • Tufts Medical CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • Boston University Medical CenterRecruiting
  • Spectrum Health Medical GroupRecruiting
  • Mayo ClinicRecruiting
  • Washington University School of MedicineRecruiting
  • Nebraska Medical CenterRecruiting
  • University of New MexicoRecruiting
  • Winthrop Hospital
  • NYU Langone Medical CenterRecruiting
  • Weill-Cornell-New York Presbyterian Hospital
  • Mount Sinai School of Medicine
  • University of RochesterRecruiting
  • Duke University Medical CenterRecruiting
  • East Carolina UniversityRecruiting
  • University of Cincinnati-Medical Science BuildingRecruiting
  • Cleveland Clinic
  • The Ohio State University Wexner Medical CenterRecruiting
  • Integris Baptist Medical CenterRecruiting
  • Oregon Clinic-Pulmonary WestRecruiting
  • Oregon Health & Science UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • Temple UniversityRecruiting
  • Allegheny General HospitalRecruiting
  • NewSTAT, PLLCRecruiting
  • Ascension Texas CardiovascularRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Memorial Hermann HospitalRecruiting
  • The Methodist Hospital Research InstituteRecruiting
  • Vermont Lung CenterRecruiting
  • University of Virginia Medical Center
  • Sentara Cardiovascular Research Institute
  • Medical College of Wisconsin/Froedtert HospitalRecruiting
  • Hospital ItalianoRecruiting
  • Sanatorio Parque S.A.Recruiting
  • Sanatorio de la Trinidad MitreRecruiting
  • Cardiologia PalmeroRecruiting
  • Hospital Britanico de Buenos AiresRecruiting
  • Fundacion Respirar
  • Fundacion FavaloroRecruiting
  • Hospital Italiano de CordobaRecruiting
  • Hospital Privado Centro Medico de Cordoba S.ARecruiting
  • Instituto de Cardiologia de CorrientesRecruiting
  • Instituto de Investigaciones ClinicasRecruiting
  • Hospital PROVINCIAL "Dr. Jose Maria Cullen"Recruiting
  • St Vincent's Hospital SydneyRecruiting
  • Royal Prince Alfred HospitalRecruiting
  • Macquarie UniversityRecruiting
  • Westmead HospitalRecruiting
  • Nepean HospitalRecruiting
  • The Prince Charles HospitalRecruiting
  • Princess Alexandra HospitalRecruiting
  • Royal Hobart HospitalRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • The Alfred HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • Medizinische Universität InnsbruckRecruiting
  • Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1Recruiting
  • AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20Recruiting
  • Cliniques Universitaires de Bruxelles Hopital ErasmeRecruiting
  • UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49Recruiting
  • HC-UFG - Hospital das Clínicas da Universidade Federal de GoiásRecruiting
  • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre TeresaRecruiting
  • Hospital Sao Lucas da PUC-RSRecruiting
  • Irmandade da Santa Casa de Misericórdia de Porto AlegreRecruiting
  • UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus BotucatuRecruiting
  • Hospital Sao PauloRecruiting
  • Instituto do CoracaoRecruiting
  • MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.Recruiting
  • MHAT "Sveta Anna" Sofia ADRecruiting
  • Peter Lougheed CentreRecruiting
  • LHSC - Victoria HospitalRecruiting
  • University Health Network-Toronto General HospitalRecruiting
  • SMBD Jewish General Hospital d/b/a Jewish General HospitalRecruiting
  • Institut Universitaire de Cardiologie et de Pneumologie de QuebecRecruiting
  • Instiuto Nacional del ToraxRecruiting
  • Beijing Shijitan Hospital, Capital Medical UniversityRecruiting
  • Guangdong Provincial People's HospitalRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • Shanghai Pulmonary HospitalRecruiting
  • Fuwai Hospital, Chinese Academy of Medical SciencesRecruiting
  • Fuwai Central China Cardiovascular HospitalRecruiting
  • Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6Recruiting
  • University Clinic for Pulmonary Diseases, Jordanovac 104Recruiting
  • Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2Recruiting
  • Copenhagen University Hospital (Rigshospitalet)Recruiting
  • Århus UniversitetshospitalRecruiting
  • CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l HopitalRecruiting
  • CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la ChantourneRecruiting
  • CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. RaimondRecruiting
  • CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du MorvanRecruiting
  • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard PinelRecruiting
  • CHU de Rouen - Hôpital Charles NicolleRecruiting
  • Groupement Hospitalier Sud - Hôpital BicêtreRecruiting
  • CHU Besançon - Hôpital Jean MinjozRecruiting
  • CHU de Brest - Hôpital de la Cavale BlancheRecruiting
  • CHRU de Lille - Hopital CardiologiqueRecruiting
  • Hôpital Nord - CHU MarseilleRecruiting
  • Thoraxklinik-Heidelberg Zentrum für Pulmonale HypertonieRecruiting
  • Universitätsmedizin GreifswaldRecruiting
  • Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1Recruiting
  • Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41Recruiting
  • Universitätsklinikum Leipzig, Medizinische Klinik II, PneumologieRecruiting
  • Schwarzwald-Baar KlinikumRecruiting
  • Universitaetsklinikum Carl Gustav Carus TU DresdenRecruiting
  • Universitaetsklinikum Hamburg-EppendorfRecruiting
  • University General Hospital of AlexandroupolisRecruiting
  • "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou AvenueRecruiting
  • University General Hospital AttikonRecruiting
  • AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi StreetRecruiting
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Családorvosi Intézet és RendelőRecruiting
  • Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.Recruiting
  • The Lady Davis Carmel Medical Center, 7 Michal st.Recruiting
  • Hadassah Ein Kerem Medical Center, Kiryat HadassahRecruiting
  • Meir Medical Center, 59 Tshernichovski st.Recruiting
  • Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floorRecruiting
  • Tel Aviv Sourasky Medical Center, 6 Weizmann St.Recruiting
  • Istituto Mediterraneo Trapianti e Terapie a Alta Specializzazione (IRCCS-ISMETT)Recruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1Recruiting
  • IRCC Ospedale Policlinico San MartinoRecruiting
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35Recruiting
  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)Recruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155Recruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Gachon University Hospital Gil Medical CenterRecruiting
  • Instituto Nacional de Cardiologia Dr Ignacio Chavez RiveraRecruiting
  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador ZubiranRecruiting
  • CICUM San MiguelRecruiting
  • Unidad de Investigacion Clinica en Medicina, S.C.Recruiting
  • VU Medisch Centrum, De Boelelaan 1117Recruiting
  • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80Recruiting
  • NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18Recruiting
  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2Recruiting
  • Premium Clinic Wrocław CM, Podwale 83/17Recruiting
  • Hospital Garcia de Orta, E.P.ERecruiting
  • Centro Hospitalar e Universitário de Coimbra, E.P.E.Recruiting
  • Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido ValenteRecruiting
  • Centro Hospitalar de Santo António E.P.E.Recruiting
  • Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258Recruiting
  • Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5Recruiting
  • Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21Recruiting
  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13Recruiting
  • Clinical Center of Serbia, Koste Todorovica 8Recruiting
  • Clinical Center Zemun. Clinic for internal medicine, Department of CardiologyRecruiting
  • Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4Recruiting
  • National University HospitalRecruiting
  • National Heart CentreRecruiting
  • Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, NeumologiaRecruiting
  • Hospital Clinic de Barcelona, C/ Villarroel, 170Recruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospoital Universitari i Politecnic La FeRecruiting
  • Sahlgrenska Universitetssjukhuset
  • Linköping Universitetssjukhuset
  • Norrlands Universitetssjukhus, Hjärtcentrum
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Osmangazi Uni Medical FacultyRecruiting
  • Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
  • Mersin Üniversitesi Tip Fakültesi Ciftlikköy KampüsüRecruiting
  • Gazi University Medical Faculty HospitalRecruiting
  • Uludag Universitesi Tip Fakültesi, Gorukle KampusuRecruiting
  • Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10Recruiting
  • Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti BalcovaRecruiting
  • CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.Recruiting
  • SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.Recruiting
  • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.Recruiting
  • Royal Free London NHS Foundation Trust, Pond StreetRecruiting
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman HospitalRecruiting
  • Golden Jubilee National HospitalRecruiting
  • Royal Brompton HospitalRecruiting
  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ralinepag

Placebo

Arm Description

Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.

Matching placebo tablets (oral)

Outcomes

Primary Outcome Measures

Time from randomization to the first adjudicated protocol-defined clinical worsening event
Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).

Secondary Outcome Measures

Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Change from Baseline in 6-minute walk distance (6MWD)
6MWD was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
The severity of PAH was graded according to the functional status of the subject and assessed at every visit.
Shift and proportion of subjects who attain all 3 of the following: NT-proBNP level <300 pg/mL, 6MWD >440 meters, and WHO/NYHA Functional Class I or II
Data from NT-proBNP, 6MWD, and WHO/NYHA functional class assessment were compiled as a composite endpoint at visits through Week 28.
Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) risk score
Data from NT-proBNP, 6MWD, WHO/NYHA functional class, systolic blood pressure, heart rate, and estimated glomerular filtration rate values collected at visits through Week 28 were used to calculate the composite REVEAL risk score.
Clinical improvement as defined by the absence of clinical worsening and fulfillment of at least 2 of the 3 of the following: increase in 6MWD ≥10% or ≥30 m, improvement to or maintenance of WHO FC I or II, and decrease in NT-proBNP by at least 30%.
Data from 6MWD, WHO/NYHA functional class assessment, and NT-proBNP were compiled as a composite endpoint at visits through Week 28.
Change from Baseline in health-related quality of life as measured by patient-reported outcomes.
Quality of life was assessed using patient-reported outcomes at Baseline (prior to starting study drug) and Week 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Time to first all-cause nonelective hospitalization
All nonelective hopsitalizations during the study period were collected.
Time to all-cause mortality
All deaths during the study period were collected.
Change from Baseline in heart rate recovery (HRR) following completion of the 6MWT
HRR was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Safety and tolerability of ralinepag in subjects with PAH
Safety and tolerability were assessed by adverse events.

Full Information

First Posted
July 27, 2018
Last Updated
October 24, 2023
Sponsor
United Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03626688
Brief Title
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Detailed Description
Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study who have completed the Week 28 Visit (after the target number of confirmed events is achieved) will have the option to enroll in an open-label extension (OLE) study. Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment, at the discretion of the treating physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease
Keywords
Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ralinepag
Arm Type
Experimental
Arm Description
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets (oral)
Intervention Type
Drug
Intervention Name(s)
Ralinepag
Other Intervention Name(s)
APD811
Intervention Description
Active
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time from randomization to the first adjudicated protocol-defined clinical worsening event
Description
Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).
Time Frame
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years
Secondary Outcome Measure Information:
Title
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Description
NT-proBNP was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Time Frame
Baseline to Week 28
Title
Change from Baseline in 6-minute walk distance (6MWD)
Description
6MWD was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Time Frame
Baseline to Week 28
Title
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
Description
The severity of PAH was graded according to the functional status of the subject and assessed at every visit.
Time Frame
Baseline to Week 28
Title
Shift and proportion of subjects who attain all 3 of the following: NT-proBNP level <300 pg/mL, 6MWD >440 meters, and WHO/NYHA Functional Class I or II
Description
Data from NT-proBNP, 6MWD, and WHO/NYHA functional class assessment were compiled as a composite endpoint at visits through Week 28.
Time Frame
Baseline to Week 28
Title
Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) risk score
Description
Data from NT-proBNP, 6MWD, WHO/NYHA functional class, systolic blood pressure, heart rate, and estimated glomerular filtration rate values collected at visits through Week 28 were used to calculate the composite REVEAL risk score.
Time Frame
Baseline to Week 28
Title
Clinical improvement as defined by the absence of clinical worsening and fulfillment of at least 2 of the 3 of the following: increase in 6MWD ≥10% or ≥30 m, improvement to or maintenance of WHO FC I or II, and decrease in NT-proBNP by at least 30%.
Description
Data from 6MWD, WHO/NYHA functional class assessment, and NT-proBNP were compiled as a composite endpoint at visits through Week 28.
Time Frame
Baseline to Week 28
Title
Change from Baseline in health-related quality of life as measured by patient-reported outcomes.
Description
Quality of life was assessed using patient-reported outcomes at Baseline (prior to starting study drug) and Week 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Time Frame
Baseline to Week 28
Title
Time to first all-cause nonelective hospitalization
Description
All nonelective hopsitalizations during the study period were collected.
Time Frame
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).
Title
Time to all-cause mortality
Description
All deaths during the study period were collected.
Time Frame
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).
Title
Change from Baseline in heart rate recovery (HRR) following completion of the 6MWT
Description
HRR was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Time Frame
Baseline to Week 28
Title
Safety and tolerability of ralinepag in subjects with PAH
Description
Safety and tolerability were assessed by adverse events.
Time Frame
Baseline to Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Primary diagnosis of symptomatic PAH. Has had a right heart catheterization (RHC) performed at or within 3 years prior to Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH. Has WHO/ NYHA functional class II to IV symptoms. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Has a 6MWD of ≥150 meters. If taking concomitant medications that may affect the clinical manifestations of PAH (eg, calcium channel blockers, diuretics, digoxin, or L arginine supplementation, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers), must be on a stable dose for at least 30 days prior to the Baseline Visit and the dosage maintained throughout the study. The exception is that the dose of diuretics must be stable for at least the 10 days prior to Baseline. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to the 30-Day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process during the study and for 30 days after the last dose of IMP. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of IMP. Exclusion Criteria: For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol. Has evidence of more than mild lung disease on pulmonary function tests performed within 180 days prior to, or during Screening. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF is >500 msec for both males and females. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy). Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening. Hemoglobin concentration <9 g/dL at Screening. Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) for PAH at any time prior to Baseline (use in vasoreactive testing is permitted). Subjects currently on or who were treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) for >6 months or within 90 days prior to Baseline. Subject has pulmonary veno-occlusive disease. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. A subject will not be excluded due to a positive drug screen caused by prescribed medications. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation. Prior participation in any study of ralinepag or participation in another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, as long as the subject can fulfill all other entry criteria and comply with all study procedures. Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation. Known hypersensitivity to ralinepag or any of the excipients. Life expectancy <12 months based on the Investigator's opinion. Women who are pregnant, lactating or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
United Therapeutics Global Medical Information
Phone
919-485-8350
Email
clinicaltrials@unither.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothy Nieters
Phone
205-975-4387
Email
dnieters@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Jose Tallaj, MD
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Galvez
Phone
480-342-2536
Email
galvez.alexis@mayo.edu
First Name & Middle Initial & Last Name & Degree
Robert Scott, MD
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Gordon
Phone
520-626-5472
Email
mgordon@email.arizona.edu
First Name & Middle Initial & Last Name & Degree
Dr. Franz Rischard
Facility Name
UCSD Health Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colton Carter
Phone
858-657-7122
Email
cjcarter@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Timothy Fernandes, MD
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynne Yoder
Phone
310-794-3299
Email
lyoder@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Rajan Saggar
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Berganza
Phone
323-783-5935
Email
mary.h.berganza@kp.org
First Name & Middle Initial & Last Name & Degree
Kenneth Wei, MD
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Akulov
Phone
949-419-4708
Email
anton.akulov@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Sivagini Ganesh, MD, MPH
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Withdrawn
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harold Te
Phone
310-268-4314
Email
harold.te@va.gov
First Name & Middle Initial & Last Name & Degree
Shelley Shapiro, MD, PhD
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanpreet Kaur
Phone
321-616-1746
Email
axkaur@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Namita Sood, MD
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Cunningham
Phone
805-569-7461
Email
d1cunnin@sbch.org
First Name & Middle Initial & Last Name & Degree
Jeffrey Sager, MD
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Del Rosario
Phone
650-721-2408
Email
pdelrosa@stanford.edu
First Name & Middle Initial & Last Name & Degree
Roham Zamanian, MD
Facility Name
LA Biomedical Research Institute Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Hannon
Phone
970-624-2500
Email
kelly.hannon@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
David Badesch, MD
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Underwood
Phone
303-398-1518
Email
underwoodj@njhealth.org
First Name & Middle Initial & Last Name & Degree
Patricia George, MD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Silverman
Phone
352-273-5870
Email
erin.silverman@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Ali Ataya, MD
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Central Florida Pulmonary Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Sapp
Phone
407-841-1100
Email
dsapp@cfpulmonary.com
First Name & Middle Initial & Last Name & Degree
Daniel Layish, MD
Facility Name
Investigational Drug Services, AdventHealth Orlando (Drug Shipment Address)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Stark
Phone
407-303-7556
Email
kimberly.stark@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Stacy Mandras, MD
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Briceno
Phone
954-659-6409
Email
bricenm@ccf.org
First Name & Middle Initial & Last Name & Degree
Jinesh Mehta, MD
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitzi Near
Phone
404-712-7458
Email
mnear@emory.edu
First Name & Middle Initial & Last Name & Degree
Micah Fisher, MD
Facility Name
Piedmont Healthcare Pulmonary and Critical Care Research
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Wilkins
Phone
770-745-1404
Email
elizabeth.wilkins@piedmont.org
First Name & Middle Initial & Last Name & Degree
Chad E Miller, MD
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Coslet
Phone
773-702-6049
Email
scoslet@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Remzi Bag, MD
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Withdrawn
Facility Name
Community Hearth and Vascular Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
St. Vincent Medical Group, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Renick
Phone
317-338-6666
Email
anne.renick@ascension.org
First Name & Middle Initial & Last Name & Degree
Ashwin Ravichandran, MD
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Page Scovel
Phone
319-353-5247
Email
page-scovel@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Dr. Linda Cadaret
Facility Name
Kentuckiana Pulmonary Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Robinson
Phone
502-587-8000
Email
krobinson@kpadocs.com
First Name & Middle Initial & Last Name & Degree
John McConnell, MD
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Terminated
Facility Name
Chest Medicine Associates
City
South Portland
State/Province
Maine
ZIP/Postal Code
04106
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Marshall
Phone
410-328-7623
Email
jmarshall1@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Gautam Ramani, MD
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Hays
Phone
617-632-5933
Email
mhays@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Ioana Preston
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamary Kone
Phone
617-726-2000
Email
mkone@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Josanna Rodriguez-Lopez, MD
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Finch
Phone
617-638-4475
Email
kimtobin@bu.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Klings, MD
Facility Name
Spectrum Health Medical Group
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Mueller
Phone
616-648-3568
Email
stephanie.mueller@spectrumhealth.org
First Name & Middle Initial & Last Name & Degree
Reda Girgis
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise Durst
Phone
507-538-1262
Email
durst.louise@mayo.edu
First Name & Middle Initial & Last Name & Degree
Hector Cajigas, MD
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Newton-Lovato, RN, BSN
Phone
314-454-8717
Email
elovato@im.wustl.edu
First Name & Middle Initial & Last Name & Degree
Murali Chakinala, MD
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenea Sweeter
Phone
402-559-7585
Email
jenea.sweeter@unmc.edu
First Name & Middle Initial & Last Name & Degree
Tammy Wichman, MD
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Zima
Phone
505-272-2932
Email
cpzima@salud.unm.edu
First Name & Middle Initial & Last Name & Degree
Lana Melendres-Groves, MD
Facility Name
Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Withdrawn
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anabela Barroso
Phone
212-263-9189
Email
Anabela.barroso@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Roxana Sulica, MD
Facility Name
Weill-Cornell-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Light
Phone
585-273-4608
Email
allison_light@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Dr. Daniel Lachant
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Womack
Phone
919-681-8439
Email
sam.womack@duke.edu
First Name & Middle Initial & Last Name & Degree
Terry Fortin, MD
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konnor Edwards
Phone
252-744-2391
Email
edwardsk19@students.ecu.edu
First Name & Middle Initial & Last Name & Degree
Veeranna Maddipati
Facility Name
University of Cincinnati-Medical Science Building
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Hummel
Phone
513-558-7036
Email
hummelne@ucmail.uc.edu
First Name & Middle Initial & Last Name & Degree
Jean Elwing, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Cohen
Phone
614-366-1332
Email
phillip.cohen@osumc.edu
First Name & Middle Initial & Last Name & Degree
Veronica Franco, MD
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin Mund
Phone
405-713-4413
Email
Kristin.Mund@integrisok.com
First Name & Middle Initial & Last Name & Degree
John Kingrey, MD
Facility Name
Oregon Clinic-Pulmonary West
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Persons
Phone
503-963-3093
Email
spersons@orclinic.com
First Name & Middle Initial & Last Name & Degree
Lianne Lin, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo Redmond
Phone
503-494-6994
Email
redmonlo@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Robinson, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Boyle
Phone
215-662-7227
Email
kathleen.boyle@uphs.upenn.edu
First Name & Middle Initial & Last Name & Degree
Jason Fritz, MD
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Gallagher
Phone
215-955-8184
Email
barbara.gallagher@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Michael Scharf, MD
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gayle Jones
Phone
215-707-8043
Email
gayle.jones@tuhs.temple.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Stewart, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Feathers
Phone
412-359-3802
Email
alison.feathers@ahn.org
First Name & Middle Initial & Last Name & Degree
Amresh Raina, MD
Facility Name
NewSTAT, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Hale
Phone
865-934-2673
Email
chris.hale@biomed-research.com
First Name & Middle Initial & Last Name & Degree
John Swisher, MD
Facility Name
Ascension Texas Cardiovascular
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristal Hodge, RN
Phone
512-324-3434
Email
kristal.hodge@ascension.org
First Name & Middle Initial & Last Name & Degree
Raju Reddy, MD
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalonda Williams
Phone
214-645-7101
Email
shalonda.williams@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Sonja Bartolome, MD
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Rangel
Phone
713-500-6851
Email
mary.rangel@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Bela Patel, MD
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Lee
Phone
713-363-7537
Email
jllee@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Zeenat Safdar, MD
Facility Name
Vermont Lung Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe Housenger
Phone
802-847-9803
Email
chloe.housenger@uvmhealth.org
First Name & Middle Initial & Last Name & Degree
Jessica Badlam, MD
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Withdrawn
Facility Name
Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Wuerl
Phone
414-955-7036
Email
awuerl@mcw.edu
First Name & Middle Initial & Last Name & Degree
Kenneth W Presberg, MD
Facility Name
Hospital Italiano
City
Ciudad Autonoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Scherling
Phone
(+54) 11 4959 0200
Ext
5177
Email
Anne.scherling@hospitalitaliano.org.ar
First Name & Middle Initial & Last Name & Degree
Graciela Svetliza, MD
Facility Name
Sanatorio Parque S.A.
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Poy Maria Laura
Phone
+5493413956916
Email
poymarialaura@gmail.com
First Name & Middle Initial & Last Name & Degree
Fabian Diez, MD
Facility Name
Sanatorio de la Trinidad Mitre
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paola Morara
Phone
54156-637-8955
Email
paolamorara@yahoo.com
First Name & Middle Initial & Last Name & Degree
Guillermo Bortman, MD
Facility Name
Cardiologia Palmero
City
Caba
ZIP/Postal Code
1425
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morara Paola
Phone
+541155053556
Email
paola@cardiologiapalermo.com.ar
First Name & Middle Initial & Last Name & Degree
Adrian J Lescano
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Varela
Phone
+54111515569504 x21
Email
manuela-varela@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Felipe Chertcoff
Facility Name
Fundacion Respirar
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Fundacion Favaloro
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1093AAS
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Di Loretto Miriam
Phone
541143781200
Ext
3380
Email
mloretto@ffavaloro.org
First Name & Middle Initial & Last Name & Degree
Jorge Osvaldo Caneva, MD
Facility Name
Hospital Italiano de Cordoba
City
Cordoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horacio Simondi
Phone
54-351-4106542
Email
hosimondi@yahoo.com
First Name & Middle Initial & Last Name & Degree
Daniela Garcia Brasca, MD
Facility Name
Hospital Privado Centro Medico de Cordoba S.A
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jose'
Phone
+543513109070
Email
majosecaceres@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Marcos Amuchastegui
Facility Name
Instituto de Cardiologia de Corrientes
City
Corrientes
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jose Galarza Salazan
Phone
54739-441-0000
Ext
182
Email
mariajosgalarza@hotmail.com
First Name & Middle Initial & Last Name & Degree
Eduardo Roque Perna, MD
Facility Name
Instituto de Investigaciones Clinicas
City
Mar Del Plata
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Florencia Eden
Phone
54223-491-0024
Email
mfeden@iic-mardelplata.com.ar
First Name & Middle Initial & Last Name & Degree
Pablo Martinez Monferrán, MD
Facility Name
Hospital PROVINCIAL "Dr. Jose Maria Cullen"
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florencia Gimenez
Phone
+543424537262
Email
florgimenez6@gmail.com
First Name & Middle Initial & Last Name & Degree
Cristian E Botta
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Brown
Phone
+61 2 8382 3723
Email
Karen.Brown@svha.org.au
First Name & Middle Initial & Last Name & Degree
Dr. Anne Keogh
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Lin
Phone
61 02 9515 4188
Email
qi.lin@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Edmund Man Tai Lau, MD
Facility Name
Macquarie University
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung Tran
Phone
+61 2 9812 3604
Email
hung.tran@mq.edu.au
First Name & Middle Initial & Last Name & Degree
Martin Russel Brown
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Burns
Phone
61 02 8890 7785
Email
Tracey.burns@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
John Wheatley, PhD
Facility Name
Nepean Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2751
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Mackenzie
Phone
+61 02 4734 4209
Email
Michele.Mackenzie@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Benjamin Ng, MD
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Grant
Phone
+61 7 3139 5423
Email
Michelle.grant@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Maria Pietsch Miller
Phone
+61 7 3139 4050
Email
maria.pietsch@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
John Fitzgerald Eelke Feenstra
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krystal Rudland
Phone
'+61 7 3176 5394
Email
krystal.rudland@health.qld.gov.au
Email
PAHrespiratoryresearchDepartment@health.qld.gov.au
First Name & Middle Initial & Last Name & Degree
Gregory John Keir
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy McIntosh
Phone
+61 3 6166 8287
Email
cathy.mcintosh@ths.tas.gov.au
First Name & Middle Initial & Last Name & Degree
Nathan Dwyer, MD
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Gemmell
Phone
+61 03 9231 3983
Email
Barbara.GEMMELL@svha.org.au
First Name & Middle Initial & Last Name & Degree
Dr. Wendy Stevens
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trudi Miller
Phone
'+61 3 9076 2742
Email
t.williams@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Christianne Manterfield
Email
c.manterfield@alfred.org.au
First Name & Middle Initial & Last Name & Degree
Dr. Trevor John Williams
Facility Name
Fiona Stanley Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalee Lawson
Phone
+61 08 6152 1561
Email
natalee.lawson@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Melanie Anne Lavender, MD
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graziella Plank
Phone
+4351250424162
Email
graziella.plank@i-med.ac.at
First Name & Middle Initial & Last Name & Degree
Judith Löffler-Ragg, Prof. Dr.
Facility Name
Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Steinkellner
Phone
+4373276764415
Email
claudia.steinkellner@ordensklinikum.at
First Name & Middle Initial & Last Name & Degree
Regina Steringer-Mascherbauer
Facility Name
AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Kohlbacher
Phone
+ 4314040062160
Email
lisa.kohlbacher@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Irene Lang
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie De Clippel
Phone
+3225555845
Email
marie.de.clippel@erasme.ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Prof. Jean-Luc Vachiery
Facility Name
UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evi Smeyers
Phone
+3216346842
Email
evi.smeyers@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Marion Delcroix, PhD
Facility Name
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74605-020
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriano Jose de Carvalho
Phone
+556286073907
Email
adrianojose_carvalho@hotmail.com
First Name & Middle Initial & Last Name & Degree
Daniela Graner Schuwartz Tannus Silva
Facility Name
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30441-070
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Mancuzo
Phone
(+5531)3339-8000
Email
pesquisa.clinica@hospitalmadreteresa.org.br
First Name & Middle Initial & Last Name & Degree
Frederico Thadeu Assis Figueiredo Campos
Facility Name
Hospital Sao Lucas da PUC-RS
City
Porto Alegre
State/Province
R.S
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Silvana Araujo de Oliveira
Phone
555199446555
Email
sil_arol@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Daniela Cavalet Blanco
Facility Name
Irmandade da Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-074
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natália Moreira Vieira
Phone
+55 51 3213-7068
Email
nataliavieira@haprs.com.br
First Name & Middle Initial & Last Name & Degree
Gisela Martina Bohns-Meyer
Facility Name
UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-687
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Bertani
Phone
+551438822969
Email
andre.bertani@unesp.br
First Name & Middle Initial & Last Name & Degree
Hugo Hyung Bok Yoo
Facility Name
Hospital Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04037-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thais Oliveira
Phone
+55 11 5579-2581
Email
oliveira.rodrigues@huhsp.org.br
First Name & Middle Initial & Last Name & Degree
Dr. Jaquelina Sonoe Ota Arakaki
Facility Name
Instituto do Coracao
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Silva
Phone
+55 11 2661-4179
Email
vanessa.osilva@incor.usp.br
First Name & Middle Initial & Last Name & Degree
Dr. Rogerio DeSouza
Facility Name
MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Kostova
Phone
+35929211442
Email
ekostova@abv.bg
First Name & Middle Initial & Last Name & Degree
Borislav Georgiev, MD
Facility Name
MHAT "Sveta Anna" Sofia AD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albena Staeva
Phone
+359 888 139516
Email
alns@abv.bg
First Name & Middle Initial & Last Name & Degree
Vasil Velchev, Assoc. Prof.
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Marks
Phone
4039434555
Email
jean.marks@ahs.ca
First Name & Middle Initial & Last Name & Degree
Douglas Helmersen, MD
Facility Name
LHSC - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leila MacBean
Phone
519-685-8500
Email
leila.macbean@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Sanjay Mehta, MD
Facility Name
University Health Network-Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rima Hosn
Phone
(416) 340-4800 x8181
Email
rihosn@uhnresearch.ca
First Name & Middle Initial & Last Name & Degree
John Granton
Facility Name
SMBD Jewish General Hospital d/b/a Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyda Lesenko
Phone
514-340-8222
Email
llesenko@jgh.mcgill.ca
First Name & Middle Initial & Last Name & Degree
Dr. David Langleben
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
City
Québec
State/Province
Quebec
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luce Bouffard
Phone
418-656-8711
Ext
2449
Email
luce.bouffard@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Steeve Provencher, MD
Facility Name
Instiuto Nacional del Torax
City
Providencia
State/Province
Santiago De Chile
ZIP/Postal Code
7500691
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid Von Oetinger
Phone
562-362-5455
Email
astridvon@gmail.com
First Name & Middle Initial & Last Name & Degree
Monica Zagolin
Facility Name
Beijing Shijitan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenning Zhang
Phone
+86 13621201221
Email
ningning_1974@sohu.com
First Name & Middle Initial & Last Name & Degree
Yong Wang
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivqing Chen 陈绿清
Phone
+86-13609715082
Email
lvqing.chen@sunrisesmo.com
First Name & Middle Initial & Last Name & Degree
Dr. Hui Yao 姚桦
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijuan Liu
Phone
+86 183 9097 4873
Email
lijuan.liu@sunrisesmo.com
First Name & Middle Initial & Last Name & Degree
Dr. Zaixin Yu
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Cheng
Phone
86-15001731070
Email
ling.cheng@sunrisesmo.com
First Name & Middle Initial & Last Name & Degree
Jin-Ming Liu, PhD
Facility Name
Fuwai Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Lu
Phone
86-18519723431
Email
ludan@foxmail.com
First Name & Middle Initial & Last Name & Degree
Lu Hua
Facility Name
Fuwai Central China Cardiovascular Hospital
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Zhao
Phone
18738126943
Email
han.zhao@maoxingpht.cn
First Name & Middle Initial & Last Name & Degree
Weixian Yang, MD
Facility Name
Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Ljilja
Phone
+38512902378
Email
anja.ljilja@gmail.com
First Name & Middle Initial & Last Name & Degree
Nevenka Piskac Zivkovic, MD
Facility Name
University Clinic for Pulmonary Diseases, Jordanovac 104
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Hećimović, MD
Phone
+385 1 2385 218
Email
ana.hecimovic@kbc-zagreb.hr
First Name & Middle Initial & Last Name & Degree
Miroslav Samarzija, Prof.
Facility Name
Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ambroz
Phone
+420 224 962 648
Email
david.ambroz@lf1.cuni.cz
First Name & Middle Initial & Last Name & Degree
Pavel Jansa, MD
Facility Name
Copenhagen University Hospital (Rigshospitalet)
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lene Moller Larsen
Phone
+4530797734
Email
lene.moeller.larsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Joern Carlsen
Facility Name
Århus Universitetshospital
City
Århus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Serup-Hansen
Phone
4521379697
Email
krisseru@rm.dk
First Name & Middle Initial & Last Name & Degree
Søren Mellemkjaer, MD
Facility Name
CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital
City
Strasbourg
State/Province
Bas Rhin
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien Stauder Stauder
Phone
+33369550345
Email
julien.stauder@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Matthieu Canuet, MD
Facility Name
CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne
City
Grenoble
State/Province
Isere
ZIP/Postal Code
38048
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayet Ouarab
Phone
33476765355 000000000
Email
houarab@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Hélène Bouvaist, MD
Facility Name
CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond
City
Saint-Étienne
State/Province
Loire
ZIP/Postal Code
42005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souad Bezzeghoud
Phone
33477829448
Email
souad.bezzeghoud@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Laurent Bertoletti, MD
Facility Name
CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan
City
Vandoeuvre les Nancy
State/Province
Meurthe Et Moselle
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Didier
Phone
33383153235
Email
a.didier@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Ari Chaouat, PhD
Facility Name
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel
City
Bron cedex
State/Province
Rhone
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinciane VIAILLY
Phone
+334 72 35 70 75
Email
vinciane.viailly@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Prof. Vincent Cottin
Facility Name
CHU de Rouen - Hôpital Charles Nicolle
City
Rouen cedex
State/Province
Seine Maritime
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nassima Si Belkacem
Phone
+33232885868
Email
nassima.si-belkacem@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Fabrice Bauer
Facility Name
Groupement Hospitalier Sud - Hôpital Bicêtre
City
Le Kremlin-Bicêtre
State/Province
Val De Marne
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramdane Meftali
Phone
33145217892
Email
ramdane.meftali@aphp.fr
First Name & Middle Initial & Last Name & Degree
Xavier Jais, MD
Facility Name
CHU Besançon - Hôpital Jean Minjoz
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatimata Sarr Sall
Phone
+33381219449
Email
fatimata.sarr@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Marie-France Seronde
Facility Name
CHU de Brest - Hôpital de la Cavale Blanche
City
Brest cedex 2
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedicte Le Gall
Phone
+33298145082
Email
benedicte.legall@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Francis Couturaud
Facility Name
CHRU de Lille - Hopital Cardiologique
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandine Verhaeghe
Phone
+33 3 20 44 59 62
Email
amandine.verhaeghe@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Pascal De Groote
Facility Name
Hôpital Nord - CHU Marseille
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmine Namouri-Rahmani
Phone
+33491966137
Email
yasmine.namouri@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Berangere Coltey
Facility Name
Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva-Maria Heier
Phone
+ 4962213968234
Email
eva-maria.heier@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Ekkehard Gruenig, Prof. Dr.
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Pohl
Phone
+4938348680073
Email
claudia.pohl@med.uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Ralf Ewert, Prof. Dr.
Facility Name
Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1
City
Mainz
State/Province
Rheinland Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brunhilde Fischer
Phone
+496131178386
Email
brunhilde.fischer@unimedizin-mainz.de
First Name & Middle Initial & Last Name & Degree
Kai-Helge Schmidt
Facility Name
Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines Holtz
Phone
+4968411615581
Email
ines.holtz@uks.eu
First Name & Middle Initial & Last Name & Degree
Prof. Heinrike Wilkens
Facility Name
Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans juergen Seyfarth
Phone
493419712600
Email
hans-juergen.seyfarth@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Hubert Wirtz, Prof. Dr.
Facility Name
Schwarzwald-Baar Klinikum
City
Donaueschingen
ZIP/Postal Code
78166
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Sperb
Email
marianne.sperb@sbk-vs.de
First Name & Middle Initial & Last Name & Degree
Hinrich Cordt Bremer
Facility Name
Universitaetsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Jaeckel
Phone
+49 3517965624
Email
Diana.Jaekel@uniklinikum-dresden.de
First Name & Middle Initial & Last Name & Degree
Michael Halank
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anja Paulsen
Phone
+49-40-7410-57395
Email
anja.paulsen@uke.de
First Name & Middle Initial & Last Name & Degree
Hans Klose
Facility Name
University General Hospital of Alexandroupolis
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasiliki Tsaliki
Email
vasiliki.tsal10@gmail.com
First Name & Middle Initial & Last Name & Degree
Prof. Stavros Konstantinides
Facility Name
"Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue
City
Athens
ZIP/Postal Code
17674
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Karyofyllis
Phone
+30 6932632641
Email
pakar768@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Vassilios Voudris, MD
Facility Name
University General Hospital Attikon
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Athanasios Pappas
Phone
+306981241141
Email
pappasath@yahoo.gr
First Name & Middle Initial & Last Name & Degree
Iraklis Tsagkaris
Facility Name
AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fotini Ereliadou
Phone
+302310994830
Email
f.ereliadou@hotmail.com
First Name & Middle Initial & Last Name & Degree
George Giannakoulas, PhD
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Családorvosi Intézet és Rendelő
City
Szeged
State/Province
Csongrád-Csanád
ZIP/Postal Code
Hungary
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renáta Horváth
Phone
+36-62-545-553
Email
reni66694@gmail.com
First Name & Middle Initial & Last Name & Degree
Albert Varga, MD
Facility Name
Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamasne Eva Gogl
Phone
+36203242284
Email
evi6604@gmail.com
First Name & Middle Initial & Last Name & Degree
Andras Komocsi, Prof. Dr.
Facility Name
The Lady Davis Carmel Medical Center, 7 Michal st.
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Platner Nurit
Phone
+ 972-4-8250878
Email
nuritp@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Yochai Adir, MD
Facility Name
Hadassah Ein Kerem Medical Center, Kiryat Hadassah
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tali Zelikovitz-Pahima
Phone
+ 972-50-2818505
Email
tulipit1@gmail.com
First Name & Middle Initial & Last Name & Degree
Neville Berkman, Prof.
Facility Name
Meir Medical Center, 59 Tshernichovski st.
City
Kfar- Sava
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idan Ravid
Phone
+ 97297471709
Email
idan.ravid@clalit.org.il
First Name & Middle Initial & Last Name & Degree
David Shitrit, MD
Facility Name
Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liora Yehoshua
Phone
+ 97236249923
Email
lioray@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Mordechai Kramer, Prof.
Facility Name
Tel Aviv Sourasky Medical Center, 6 Weizmann St.
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Platner Nurit
Phone
+ 972-3-6974961
Email
nuritp@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Abraham Man, MD
Facility Name
Istituto Mediterraneo Trapianti e Terapie a Alta Specializzazione (IRCCS-ISMETT)
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanna Russelli
Phone
+390912192111
Email
grusselli@ismetti.edu
First Name & Middle Initial & Last Name & Degree
Patrizio Vitulo, MD
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Musio Stefano
Phone
+393208151518
Email
musio.stefano@libero.it
First Name & Middle Initial & Last Name & Degree
Natale Brunetti, MD
Facility Name
IRCC Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pietro Ameri, Dr.
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Vanelli
Phone
+ 390255033538
Email
dyspmea.lab.policlinico@gmail.com
First Name & Middle Initial & Last Name & Degree
Marco Vicenzi
Facility Name
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ludovico Lanfranchi
Phone
+39392339245
Email
ludovicolanfranchi@gmail.com
First Name & Middle Initial & Last Name & Degree
Giuseppe Paciocco
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Maffi
Phone
+390382501326
Email
unita.sc@smatteo.pv.it
First Name & Middle Initial & Last Name & Degree
Stefano Ghio
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Proietti
Phone
+ 393495880075
Email
sara.proietti@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Roberto Badagliacca
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seul Lee
Phone
+82-2-3410-2867
Email
Leeseul0808@gmail.com
First Name & Middle Initial & Last Name & Degree
Sung-A Chang
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Na Choi
Phone
+82-2-2072-4977
Email
hannana59@gmail.com
First Name & Middle Initial & Last Name & Degree
Hyung-Kwan Kim
Facility Name
Gachon University Hospital Gil Medical Center
City
Incheon
State/Province
Namdong-gu
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Ju You
Phone
+82-10-9261-2066
Email
miju21@gilhospital.com
First Name & Middle Initial & Last Name & Degree
Wook-Jin Chung
Facility Name
Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Alberto Romero Carachuri
Phone
(777) 263-3200
Email
lromero@jmresearch.org
First Name & Middle Initial & Last Name & Degree
Tomase Rene Puliod Zamudio
Facility Name
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Lopez Spindola
Phone
5255-5487-0900 ext 6101
Email
alipez@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jose Luis Hernandez Oropeza
Facility Name
CICUM San Miguel
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Martinez
Phone
+523338489619
Email
dramony@usac.com.mx
First Name & Middle Initial & Last Name & Degree
Jorge Eduardo Rosas Cacho
Facility Name
Unidad de Investigacion Clinica en Medicina, S.C.
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Ramirez
Phone
+5218183469192
Email
alicia.ramirez@udicem.org
First Name & Middle Initial & Last Name & Degree
Carlos Jerjes Sanchez-Diaz
Facility Name
VU Medisch Centrum, De Boelelaan 1117
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwen Schotte
Phone
+31 20 444 21 93
Email
g.schotte@vumc.nl
First Name & Middle Initial & Last Name & Degree
Prof. Antonie Vonk Noordegraaf
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Individual Site Status
Enrolling by invitation
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcin Waligóra
Phone
+ 48505863235
Email
marcin.waligoora@gmail.com
First Name & Middle Initial & Last Name & Degree
Dr. Grzegorz Kopec
Facility Name
NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulina Babik
Phone
+ 48227103052
Email
paulina.babik@ecz-otwock.pl
First Name & Middle Initial & Last Name & Degree
Prof. Adam Torbicki
Facility Name
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2
City
Poznan
ZIP/Postal Code
61-848
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylwia Sławek-Szmyt
Phone
+48 61 85 49 293
Email
sylwia.slawek@skpp.edu.pl; sylwiaslawek89@gmail.com
First Name & Middle Initial & Last Name & Degree
Tatiana Mularek-Kubzdela
Facility Name
Premium Clinic Wrocław CM, Podwale 83/17
City
Wroclaw
ZIP/Postal Code
50-414
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justyna Dubiel
Phone
+48693857700
Email
justyna_dubiel@o2.pl
First Name & Middle Initial & Last Name & Degree
Ewa Mroczek
Facility Name
Hospital Garcia de Orta, E.P.E
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Noronha
Phone
+351 91 001 6543
Email
mnoronha@blueclinical.pt
First Name & Middle Initial & Last Name & Degree
Filipa Ferreira
Facility Name
Centro Hospitalar e Universitário de Coimbra, E.P.E.
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Pais
Phone
+351239483755
Email
danielapais24@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria de Graça Castro
Facility Name
Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Sousa
Phone
+351962253985
Email
anitasousa@medicina.ulisboa.pt
First Name & Middle Initial & Last Name & Degree
Riu Plácido
Facility Name
Centro Hospitalar de Santo António E.P.E.
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Catarina Alves
Phone
+351 914 028 019
Email
acatarinaalves.defi@chporto.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Fabienne Gonçalves, MD
Facility Name
Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radu Teodora
Phone
+40722266790
Email
teodora.madaras@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ioan Coman, MD
Facility Name
Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5
City
Bucuresti
ZIP/Postal Code
050159
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Lucia Toma
Phone
+40723195385
Email
claudiatoma@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Miron Bogdan, PhD
Facility Name
Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21
City
Cluj-Napoca
ZIP/Postal Code
400001
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rancea Raluca-Alina
Phone
40264591224
Email
raluca_rancea@yahoo.com
First Name & Middle Initial & Last Name & Degree
Stefan Dan Cezar Mot, PhD
Facility Name
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicoleta Bertici
Phone
+40740273199
Email
bertnicol2002@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dr. Voicu Mircea Tudorache
Facility Name
Clinical Center of Serbia, Koste Todorovica 8
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miryana Stamenic
Phone
+381113617777
Email
mira.stamenic@gmail.com
First Name & Middle Initial & Last Name & Degree
Arsen Ristic, Prof. Dr.
Facility Name
Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ljiljana Dundjerovic
Phone
+381113772617
Email
ljiljanadundjerovic@outlook.com
First Name & Middle Initial & Last Name & Degree
Ivan Stankovic, Assoc Prof
Facility Name
Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Srdjan Gavrilović
Phone
+381214805198
Email
srdjan_gavrilovic@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jovan Matijasevic
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sik Yin Tan (Vion)
Phone
+65-6601-5896
Email
sik_yin_tan@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Dr. Ting Ting Low
Facility Name
National Heart Centre
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Lee
Phone
+6587256754
Email
gina.lee.s.h@nhcs.com.sg
First Name & Middle Initial & Last Name & Degree
Soo Teik Lim
Facility Name
Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Lopez Rodriguez
Phone
34932746107
Email
solopez@vhebron.net
First Name & Middle Initial & Last Name & Degree
Manuel Lopez Meseguer, MD
Facility Name
Hospital Clinic de Barcelona, C/ Villarroel, 170
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lola Sanz
Phone
+34932271701
Email
mdsanz@clinic.cat
First Name & Middle Initial & Last Name & Degree
Dr. Joan Albert Barbera Mir
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Ochoa Parra
Phone
34913908282
Email
nuriaochoaparra@hotmail.com
First Name & Middle Initial & Last Name & Degree
Pilar Escribano Subias, MD
Facility Name
Hospoital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medina Maria Jose
Phone
+34651401194
Email
medinamajose1@gmail.com
First Name & Middle Initial & Last Name & Degree
Raquel López Reyes, MD
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Withdrawn
Facility Name
Linköping Universitetssjukhuset
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Withdrawn
Facility Name
Norrlands Universitetssjukhus, Hjärtcentrum
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Withdrawn
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiu-Chuan Yang
Phone
886928716566
Email
september1591@gmail.com
First Name & Middle Initial & Last Name & Degree
Chih-Hsin Hsu, MD
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Huang
Phone
886-2-2312-3456
Ext
65683
Email
ntuhpah@gmail.com
First Name & Middle Initial & Last Name & Degree
Hsao-Hsun Hsu
Facility Name
Osmangazi Uni Medical Faculty
City
Eskişehir
State/Province
Odunpazari
ZIP/Postal Code
26040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akın Aydın
Phone
905548687991
Email
Akin.aydin@medismart.com.tr
First Name & Middle Initial & Last Name & Degree
Yuksel Cavusoglu, MD
Facility Name
Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
City
Adana
State/Province
Saricam
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Enrolling by invitation
Facility Name
Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü
City
Mersin
State/Province
Yenisehir
ZIP/Postal Code
33343
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emel Sahin
Phone
+90 530 917 96 59
Email
emel.sahin@medismart.com.tr
First Name & Middle Initial & Last Name & Degree
Dilek Cicek Yilmaz, MD
Facility Name
Gazi University Medical Faculty Hospital
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabia Sahin
Phone
+905346216711
Email
rabia.sahin@medismart.com.tr
First Name & Middle Initial & Last Name & Degree
Gulten Tacoy, MD
Facility Name
Uludag Universitesi Tip Fakültesi, Gorukle Kampusu
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edanur Dogangil
Phone
+905373977947
Email
edanur.dogangil@atlascro.com.tr
First Name & Middle Initial & Last Name & Degree
Prof. Sumeyye Gullulu
Facility Name
Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nihat Yildirim
Phone
+90 506 899 18 54
Email
aven2003@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bulent Mutlu
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bengü Balkan
Phone
+90 505 308 87 89
Email
bengu.balkan@atlascro.com.tr
First Name & Middle Initial & Last Name & Degree
Bahri Akdeniz
Facility Name
CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.
City
Dnipro
ZIP/Postal Code
49070
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
Email
liv@414.dp.ua
First Name & Middle Initial & Last Name & Degree
Larisa Vasilyeva, MD
Facility Name
SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataliia Pendalchuk
Phone
38096 83 26 464
Email
pendalchuk@gmail.com
First Name & Middle Initial & Last Name & Degree
Volodymyr Gavrysyuk, PhD
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjana Abrahamovych
Phone
380322 769763
Email
marjana2003@ukr.net
First Name & Middle Initial & Last Name & Degree
Orest Abrahamovych, MD
Facility Name
Royal Free London NHS Foundation Trust, Pond Street
City
London
State/Province
Greater London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Davey
Phone
+ 442073177544
Email
stephanie.davey@nhs.net
First Name & Middle Initial & Last Name & Degree
John Coghlan
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Brown
Phone
+441912231608
Email
jamie.brown@nuth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Dr. James Lordan
Facility Name
Golden Jubilee National Hospital
City
Glasgow
State/Province
West Dunbartonshire
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Val Irvine
Phone
+441419515485
Email
val.irvine@goldenjubilee.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Alistair Colin Church
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Da Costa
Phone
+4402073528121
Email
r.dacosta@rbht.nhs.uk
First Name & Middle Initial & Last Name & Degree
Colm Thomas McCabe
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisca Mautadin
Phone
+442033111234
Email
francisca.mautadin@imperial.nhs.uk
First Name & Middle Initial & Last Name & Degree
Luke Howard, MD

12. IPD Sharing Statement

Learn more about this trial

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

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