Back to resultsA Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease (SERENADE)
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Macitentan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction
Eligibility Criteria
Inclusion Criteria:
- Signs or symptoms of Heart Failure (HF) (NYHA FC I I and II I ) requiring treatment with at least one oral diuretic (any type)
- Left ventricular ejection fraction (LVEF) ≥ 40% (by echocardiography at Screening)
- Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening
- Elevated NT-proBNP
- Pulmonary vascular disease or right ventricular dysfunction
Exclusion Criteria:
- Any prior valid measurement of LVEF < 40%. An echocardiogram is considered valid if its quality is sufficient to allow accurate assessment of LVEF and if it is reflective of the true status of the subject
- Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc)
- Systolic blood pressure (SBP) ≥ 180 mmHg, or diastolic blood pressure (DBP) ≥ 110 mmHg during Screening
- Hemoglobin < 100g/L (< 10 g/dl) at Screening
- Significant parenchymal lung disease (e.g., severe COPD, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism)
- Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2
- Severe hepatic impairment, e.g., Child Pugh Class C
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Mayo Clinic Arizona
- Cedars Sinai Heart Institute
- Sharp Memorial Hospital
- Harbor Ucla Medical Center
- South Denver Cardiology Associates PC
- Northwestern University Feinberg School of Medicine
- University Of Iowa - Hospitals & Clinics
- University of Maryland
- Massachusetts General Hospital
- Washington University School of Medicine
- Weill Cornell Medicine
- Peak Clinical Trials
- University of North Carolina (UNC) - School of Medicine
- The Lindner Clinical Trial Center
- Lehigh Valley Health Network
- Drexel University College of Medicine
- Allegheny
- Vascular Medicine Institute University Of Pittsburgh
- AnMed Health
- North Dallas Research Associates
- Baylor Scott & White Research Institute
- Inova Heart and Vascular Institute
- MultiCare Health System
- Aurora Saint Lukes Medical Center
- CCBR - Buenos Aires - AR
- Clínica Adventista Belgrano
- Centro Médico Dra. De Salvo
- Instituto de Investigaciones Clinicas Mar del Plata
- Medizinische Universität Wien
- Maestri E Kormann Consultoria Médico- Científica Ltda
- Rede D´or Sao Luiz S.A. - Hospital do Coracao do Brasil
- Instituto de Pesquisa Clinica de Campinas
- Instituto do Coracao de Marília
- Instituto de Moléstias Cardiovasculares Tatuí
- Specialized Hospital for Active Treatment in Cardiology - Pleven
- Diagnostic - Consulting Center I-Sliven
- Multiprofile Hospital for Active Treatment - National Heart Hospital
- University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
- Fakultni nemocnice Brno
- Fakultni nemocnice Hradec Kralove
- University Hospital Plzeň-Lochotín
- General University Hospital II.department of Internal Medicine-cardiology and angiology
- IKEM
- Aarhus Universitetshospital
- Bispebjerg Og Frederiksberg Hospital
- Sydvestjysk Sygehus
- Hopital Henri Mondor
- CHU de Grenoble - Hopital Albert Michallon
- Hopital de Bicetre
- Hopital Cardiologique
- CHU Rouen - Hopital Charles Nicolle
- Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
- Universitatsklinikum Bonn
- Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
- Universitaetsklinikum Giessen
- Universitaetsklinikum Schleswig-Holstein Campus Kiel
- Herzzentrum Uniklinik Köln Klinik III für Innere Medizin
- Klinikum Würzburg Mitte gGmbH Standort Missioklinik
- Budai Irgalmasrendi Korhaz
- Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika
- Magyar Honvedseg Egeszsegugyi Kozpont
- Barzilai Medical Center
- Hillel Yaffe Medical Center
- Bnai Zion Medical Center
- Wolfson Medical Center
- Hadassah Medical Center
- Galilee Medical Center
- Rabin Medical Center, Beilinson Campus
- Kaplan Medical Center
- Uniwersyteckie Centrum Kliniczne
- Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn
- Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
- 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
- Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III
- Cardiomed
- SAL MED Pitesti
- Cmi Dr Podoleanu Cristian
- Ekaterinburg City Clinical Hospital #14
- Federal State Budget Scientific Institution
- Krasnodar Regional Clinical Hospital
- Moscow City Clinical Hospital No.51
- National Medical Research Center of Cardiology of MoH of Russian Federation
- State Healthcare Institution, Regional Clinical Cardiology Dispensary
- Federal State Budgetary Institution
- State Autonomous Healthcare Institution Of Yaroslavl Region
- Hospital Vall d'Hebron
- Hospital General Universitario Gregorio Marañon
- Hospital Clinico San Carlos
- Hospital Clinico Universitario de Valencia
- Hospital Universitario La Fe
- Sahlgrenska Universitetsjukhuset
- Royal Papworth Hospital NHS Foundation Trust
- Castle Hill Hospital
- Royal Free Hospital
- Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Macitentan
Placebo
Arm Description
Subjects randomized to the macitentan arm receives one tablet of macitentan 10 mg every day for at least 24 to maximum 52 weeks.
Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks.
Outcomes
Primary Outcome Measures
Percent of Baseline N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Assessed at Week 24
Percent of baseline NT-proBNP assessed at Week 24 was reported. Percent of baseline is calculated as the ratio of the Week 24 NT-proBNP value over baseline value, expressed in percentage. NT-proBNP is one of the best established cardiovascular response markers among all available surrogates in heart failure (HF).
Secondary Outcome Measures
Change From Baseline to Week 24 in the Clinical Summary Score Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
The KCCQ is a validated health related quality of life measure for heart failure. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Clinical summary score is one of the quality of life variable of interest derived from KCCQ. Clinical summary score is the mean of domains: physical limitations score (6 items) and total symptom score (2 items [symptoms frequency and symptom burden]). The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Change From Baseline to Week 24 in Accelerometer-assessed Proportion of Time Spent in Light to Vigourous Physical Activity
Physical activity is assessed by accelerometer as the proportion of time spent in light to vigorous physical activity based on a threshold of greater than (>)100 activity counts per minute and expressed as change from baseline to Week 24.
Number of Participants With Worsening of Heart Failure (WHF) Events Over 52 Weeks
Number of participants with WHF events were reported. A WHF event includes HF death, hospitalization for WHF or an urgent visit for WHF.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03153111
Brief Title
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Acronym
SERENADE
Official Title
A Multi-center, Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
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
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.
The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Macitentan
Arm Type
Active Comparator
Arm Description
Subjects randomized to the macitentan arm receives one tablet of macitentan 10 mg every day for at least 24 to maximum 52 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Macitentan
Other Intervention Name(s)
ACT-064992
Intervention Description
macitentan 10 mg; film-coated tablet; oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
film-coated tablet (identical to the macitentan tablet); oral use
Primary Outcome Measure Information:
Title
Percent of Baseline N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Assessed at Week 24
Description
Percent of baseline NT-proBNP assessed at Week 24 was reported. Percent of baseline is calculated as the ratio of the Week 24 NT-proBNP value over baseline value, expressed in percentage. NT-proBNP is one of the best established cardiovascular response markers among all available surrogates in heart failure (HF).
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 24 in the Clinical Summary Score Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Description
The KCCQ is a validated health related quality of life measure for heart failure. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Clinical summary score is one of the quality of life variable of interest derived from KCCQ. Clinical summary score is the mean of domains: physical limitations score (6 items) and total symptom score (2 items [symptoms frequency and symptom burden]). The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Time Frame
Baseline to Week 24
Title
Change From Baseline to Week 24 in Accelerometer-assessed Proportion of Time Spent in Light to Vigourous Physical Activity
Description
Physical activity is assessed by accelerometer as the proportion of time spent in light to vigorous physical activity based on a threshold of greater than (>)100 activity counts per minute and expressed as change from baseline to Week 24.
Time Frame
Baseline to Week 24
Title
Number of Participants With Worsening of Heart Failure (WHF) Events Over 52 Weeks
Description
Number of participants with WHF events were reported. A WHF event includes HF death, hospitalization for WHF or an urgent visit for WHF.
Time Frame
Weeks 16, 24, 36, 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signs or symptoms of Heart Failure (HF) (NYHA FC I I and II I ) requiring treatment with at least one oral diuretic (any type)
Left ventricular ejection fraction (LVEF) ≥ 40% (by echocardiography at Screening)
Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening
Elevated NT-proBNP
Pulmonary vascular disease or right ventricular dysfunction
Exclusion Criteria:
Any prior valid measurement of LVEF < 40%. An echocardiogram is considered valid if its quality is sufficient to allow accurate assessment of LVEF and if it is reflective of the true status of the subject
Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc)
Systolic blood pressure (SBP) ≥ 180 mmHg, or diastolic blood pressure (DBP) ≥ 110 mmHg during Screening
Hemoglobin < 100g/L (< 10 g/dl) at Screening
Significant parenchymal lung disease (e.g., severe COPD, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism)
Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2
Severe hepatic impairment, e.g., Child Pugh Class C
Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Cedars Sinai Heart Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Harbor Ucla Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University Of Iowa - Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1081
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Peak Clinical Trials
City
Apex
State/Province
North Carolina
ZIP/Postal Code
27502
Country
United States
Facility Name
University of North Carolina (UNC) - School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219-2906
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Allegheny
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Vascular Medicine Institute University Of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
North Dallas Research Associates
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Inova Heart and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Aurora Saint Lukes Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
CCBR - Buenos Aires - AR
City
Buenos Aires
ZIP/Postal Code
C1430CKE
Country
Argentina
Facility Name
Clínica Adventista Belgrano
City
Caba
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Centro Médico Dra. De Salvo
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Mar del Plata
City
Mar Del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Maestri E Kormann Consultoria Médico- Científica Ltda
City
Blumenau
ZIP/Postal Code
89020-430
Country
Brazil
Facility Name
Rede D´or Sao Luiz S.A. - Hospital do Coracao do Brasil
City
Brasilia
ZIP/Postal Code
70390-700
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica de Campinas
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Instituto do Coracao de Marília
City
Marilia
ZIP/Postal Code
17515-000
Country
Brazil
Facility Name
Instituto de Moléstias Cardiovasculares Tatuí
City
Tatuí
ZIP/Postal Code
18270-170
Country
Brazil
Facility Name
Specialized Hospital for Active Treatment in Cardiology - Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Diagnostic - Consulting Center I-Sliven
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - National Heart Hospital
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Plzeň-Lochotín
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
General University Hospital II.department of Internal Medicine-cardiology and angiology
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
IKEM
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Bispebjerg Og Frederiksberg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Sydvestjysk Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Hopital Henri Mondor
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Grenoble - Hopital Albert Michallon
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital de Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Hopital Cardiologique
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Rouen - Hopital Charles Nicolle
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Herzzentrum Uniklinik Köln Klinik III für Innere Medizin
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
City
Würzburg
ZIP/Postal Code
97074
Country
Germany
Facility Name
Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
City
Wroclaw
ZIP/Postal Code
50-513
Country
Poland
Facility Name
Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Cardiomed
City
Craiova
ZIP/Postal Code
200505
Country
Romania
Facility Name
SAL MED Pitesti
City
Pitesti
ZIP/Postal Code
110437
Country
Romania
Facility Name
Cmi Dr Podoleanu Cristian
City
Targu-Mures
ZIP/Postal Code
540503
Country
Romania
Facility Name
Ekaterinburg City Clinical Hospital #14
City
Ekaterinburg
ZIP/Postal Code
620039
Country
Russian Federation
Facility Name
Federal State Budget Scientific Institution
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Krasnodar Regional Clinical Hospital
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital No.51
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
National Medical Research Center of Cardiology of MoH of Russian Federation
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
State Healthcare Institution, Regional Clinical Cardiology Dispensary
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Federal State Budgetary Institution
City
St Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution Of Yaroslavl Region
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska Universitetsjukhuset
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Royal Papworth Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2RX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
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