Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure with Preserved Ejection Fraction,, Mineralocorticoid receptor antagonist (MRA)
Eligibility Criteria
Inclusion Criteria:
- Participant (male or female) must be aged 40 years and older.
- Diagnosis of heart failure with New York Heart Association(NYHA) class II-IV, ambulatory or hospitalized primarily for heart failure.
- On diuretic treatment for at least 30 days prior to randomization.
- Documented left ventricular ejection fraction (LVEF) of ≥40% measured by any modality within the last 12 months.
- Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: left atrial diameter (LAD) ≥3.8cm, left atrial area (LAA) ≥20cm2, left atrial volume index (LAVI) >30 mL/m2, left ventricular mass index (LVMI) ≥115 g/m2 (♂)/ 95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm
n-terminal prohormone B-type natriuretic peptide (NT-proBNP) ≥300 pg/mL (BNP ≥100 pg/mL) in sinus rhythm and patient does not have an ongoing diagnosis of paroxysmal atrial fibrillation or NT-proBNP ≥900 pg/mL (BNP ≥300 pg/mL) in atrial fibrillation (or if atrial fibrillation status is unknown or if patient has an ongoing diagnosis of paroxysmal atrial fibrillation) for participants obtained at the following time:
- Within 90 days prior to randomization if patient had been hospitalized for heart failure (HF) requiring initiation or change in HF therapy or if patient had an urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization OR
- Within 30 days prior to randomization if patient has not been hospitalized for HF nor had an urgent HF visit within the past 90 days.
- Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.
Exclusion Criteria:
- Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m² at either screening or randomization visit.
- Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
- Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization
- Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization
- Coronary artery bypass graft surgery in the 90 days prior to randomization
- Percutaneous coronary intervention in the 30 days prior to randomization
- Stroke or transient ischemic cerebral attack within 90 days prior to randomization
- Probable alternative cause of participants' HF symptoms that in the opinion of the investigator primarily accounts for patient's dyspnea such as significant pulmonary disease, anemia or obesity. Specifically, patients with the below are excluded: Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of primary pulmonary arterial hypertension, Hemoglobin <10 g/dl, Valvular heart disease considered by the investigator to be clinically significant, Body Mass Index (BMI) >50 kg/m2 at screening
- Systolic blood pressure(SBP) ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at least 2-minute apart, at screening or at randomization.
- Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, ritonavir, indinavir, cobicistat, clarithromycin) or moderate or potent CYP3A4 inducers, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period.
Sites / Locations
- Cardiology, PC
- Eastern Shore Research Institute, LLC | Fairhope, AL
- Mobile Heart Specialists, PC
- University of Arizona Health Science Center
- Heart Clinic Arkansas
- WestSide Medical
- California Heart Specialists
- UC Irvine Medical Center
- Sutter Heart & Vascular Institute
- NorthBay Clinical Research, LLC | Santa Rosa, CA
- Harbor - UCLA Medical Center
- Blue Coast Research Center, LLC
- Interventional Cardio Medical- DCT Department
- Interventional Cardiology Medical Group | West Hills, CA
- VA Eastern Colorado Health Care System
- Colorado Springs Cardiology
- South Denver Cardiology Associates, PC
- Cardiovascular and Vein Center of Florida
- Nova Clinical Research | Brandenton, FL
- Cardiology Associates Research Company
- Malcom Randall VA Medical Ctr
- LifeSpring Research Foundation, LLC
- Southwest Florida Research
- East Coast Institute for Research, LLC - St Augustine
- Cardiology Partners
- IACT Health
- Atlanta Heart Specialists, LLC
- Advocate Illinois Masonic Medical Center
- Advocate Good Samaritan Hospital
- Advocate Condell Medical Center
- Edward Hospital-Main Campus
- Captain James A. Lovell Federal Health Care Center
- Methodist Medical Center of Illinois
- Midwest Cardiovascular Research and Education Foundation
- Reid Physician Associates | Cardiology Department
- Kansas Nephrology Research Institute, LLC
- Baptist Health Paducah
- Cardiovascular Associates Research, LLC
- Heart Clinic of Hammond
- Louisiana Heart Center Research - Slidell
- Southern Clinical Research, LLC
- Maine Medical Partners-Maine Health Cardiology
- Maryland Cardiovascular Specialists
- John Hopkins Outpatient Center
- Suburban Hospital
- Cardiovascular Specialists of Central Maryland, PA
- Henry Ford Health System
- Aa Mrc, Llc
- Western Michigan University School of Medicine
- M Health Fairview
- M Health Fairview Heart Clinic - Fulton
- St. Cloud Hospital
- Baptist Heart -Cardiology - DCT Dept
- University of Mississippi Medical Center
- Harry S. Truman Memorial Veterans Hospital
- Clinical Research Consultants
- St. Luke's Mid America Heart Institute
- Mercy Hospital Springfield
- Logan Health Research
- Nebraska Heart Institute- Grand Island
- CHI Health Nebraska Heart
- Advanced Heart Care, LLC | Bridgewater, NJ
- NJ Medcare/NJ Heart
- Garden State Heart Care
- Cardiac Care & Vascular Medicine
- Hudson Valley Cardiovascular Practice, PC
- Division of Cardiovascular Research at Peconic Bay Med Ctr
- Laurelton Heart Specialists
- Saratoga Clinical Research, LLC
- Stony Brook University Medical Center
- Northwell Health Phys. Partners Cardiology at Valley Stream
- Kernodle Clinic West, Private Diagnostic Clinic PLLC
- University of North Carolina
- Wake Forest Baptist Health
- Kettering Health Network
- Rama Research LLC | Marion, OH
- Mercy Health - St. Elizabeth Youngstown Hospital
- South Oklahoma Heart Research, LLC
- Capital Area Research, LLC
- Doylestown Cardiology Associates-VIAA
- Kent Hospital
- Trident Cardiology Associates, PA
- Carolina Heart Specialists
- PMG Research of Charleston
- Monument Health Clinical Research
- Sanford USD Medical Center
- The Stern Cardiovascular Foundation, Inc.
- Apex Cardiology, LLC
- Memphis VA Medical Center
- Cardiovascular Research of Knoxville
- Seton Heart Institute
- Texas Health Physicians Group - Dallas
- Southwest Family Medicine Associates
- Texas Health Physicians Group - Fort Worth
- University of Texas Medical Branch at Galveston
- Houston Heart & Vascular Associates
- South Texas Cardiovascular Consultants, PLLC / Kerrville, TX
- North Dallas Research Associate | McKinney, TX
- ClinRx Research, LLC
- South Texas Cardiovascular Consultants, PLLC /San Antonio,TX
- Clinical Advancement Center, PLLC
- Northwest Houston Heart Center
- University of Utah Health Care
- IMG Cardiology- Fairfax
- Virginia Heart
- Virginia Heart
- Sentara Norfolk General Hospital
- Salem VA Medical Center
- Selma Medical Associates
- William S. Middleton Memorial Veterans Hospital
- Aurora Saint Luke's Medical Center
- Aspirus Research Institute
- IMOBA Investigaciones Clinicas
- Clínica Coronel Suarez
- Hospital Italiano de La Plata | Clinical Research Department
- Centro de Investigación Médica Lanús
- Sanatorio Modelo Quilmes
- Corporación Médica de General San Martín
- Instituto de Investigaciones Clínicas Zárate
- Hospital Militar Central "CIR. MY. C. Argerich"
- Centro de Investigaciones Metabólicas
- Instituto Cardiovascular de Buenos Aires
- Centro de Investigaciones Clínicas
- Centro de Especialidades Médicas
- Instituto Cardiovascular
- Instituto Médico de la Fundación Estudios Clinicos
- Instituto de Cardiología
- Inst. de Cardiología de Corrientes Juana Francisca Cabral
- Clínica Privada del Prado
- Instituto Médico DAMIC- Fundación Rusculleda
- Centro de Investigaciones Clinicas del Litoral
- John Hunter Hospital
- The Wesley Hospital
- Royal Brisbane and Women's Hospital
- Flinders Medical Centre
- GenesisCare Leabrook
- GenesisCare Ringwood
- The Prince Charles Hospital
- Klinikum Klagenfurt am Wörthersee
- Universitätsklinikum St. Pölten
- Krankenhaus St. Josef Braunau
- Medizinische Universität Graz
- Landeskrankenhaus Feldkirch
- Uniklinikum Salzburg - Landeskrankenhaus
- Universitätsklinikum AKH Wien
- Imed19-privat
- Klinik Floridsdorf - Krankenhaus Nord
- Santa Casa de Misericórdia da Bahia
- Hospital do Coração do Brasil
- Hospital das Clínicas de Goiânia
- QUANTA Diagnósticos e Terapia
- Núcleo de Pesquisa Clínica do Hospital Angelina Caron
- Fundação Universidade de Caxias do Sul
- Hospital de Clínicas de Porto Alegre
- Hospital Mae de Deus
- Hospital Nossa Senhora da Conceição
- MK Consultoria Médico Científica Ltda/Angiocor Blumenau
- Hospital Felício Rocho
- Inst. Pesq. Clínica de Campinas - Saraiva & Berlinger
- ICM - Instituto do Coração de Marília
- Centro Avançado de Pesquisa para Diagnóstico - CAPED
- IMC - Instituto de Moléstias Cardiovasculares Tatui
- Santa Casa de Misericórdia de Votuporanga
- PUC Campinas
- Eurolatino Pesquisas Médicas Ltda.
- Clínica do Coração
- Ambulatory facility for specialized outpatient medical care
- MHAT Haskovo
- MHAT Zdrave
- ¿ultidisc. hosp. for act. treatm. Sveti Georgi - Pernik OOD
- Medical Center Medconsult Pleven
- Medical centre Hipokrat - N EOOD
- Multiprofile Hospital for Active Treatment Medline Clinic
- Multiprofile Hospital for Active Treatment Sveta Karidad | Cardiology Department
- MHAT Shumen AD
- MHAT Hadzhi Dimitar
- Second Medical Center Sofia EOOD
- Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
- NMTH Tzar Boris III
- MHAT National Cardiology Hospital EAD
- Medical Center Hera
- UMHAT Tsaritsa Joanna-ISUL EAD Sofia
- Multiprofile Hospital for Active Treatment Sveta Sofia
- MHAT Trakia
- MHAT Dr Stefan Cherkezov
- MHAT Sveti Pantaleymon - Yambol
- Fraser Clinical Trials, Inc.
- St. Boniface Hospital
- G.A. Research Associates, Ltd.
- Queen Elizabeth II Health Sciences Centre
- Brampton Clinical Trials
- Cambridge Cardiac Care Center
- Vizel Cardiac Research
- London Health Sciences Centre
- KMH Cardiology Clinics Inc.
- North York Diagnostic and Cardiac Centre
- Oakville Cardiovascular Research
- Office of Dr. James Cha, MD
- Kawartha Cardiology Clinical Trials
- Corcare
- Medicus MFC Inc.
- Women's College Hospital
- Mount Sinai Hospital
- Centre intégré de santé et de services sociaux de Laval, Hôp
- Clinique Sante Cardio MC
- Centre Hospitalier de l'Université de Montréal-CHUM
- McGill University Health Centre - Glen Site
- Fujian Provincial Hospital
- Lanzhou University Second Hospital
- The First Affiliated Hospital,Sun Yat-Sen University
- Guangdong Provincial People's Hospital
- Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ.
- The First Affiliated Hospital of Guangzhou University of TCM
- Nanfang Hospital, Southern Medical University
- The First Affiliated Hospital of Jinan University
- Guizhou Provincial People's Hospital
- Hainan Provincial People's Hospital
- Hainan Third People's Hospital (Province Nongken Sanya Hopt)
- The First Hospital of Hebei Medical Univesity
- Daqing Oilfield General Hospital
- Xinxiang Central Hospital
- Changsha Central Hospital
- Hunan Provincial People's Hospital
- The Third Xiangya Hospital of Central South University
- Huai'an First People's Hospital, Nanjing Medical University
- The First People's Hospital of Lianyungang
- The Second Affiliated Hospital of Nanjing Medical university
- NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School
- Zhongda Hospital Southeast University
- Jiangsu Province Hospital
- Nanjing Jiangning Hospital
- 1st Affiliated hospital of Soochow University
- The First Hospital of Jilin University
- Jilin Province People's Hospital
- Panjin Liaohe Oilfield Gem Flower Hospital
- The First People's Hospital of Yinchuan
- General Hospital of Ningxia Medical University
- Jinan Central Hospital
- Shanxi Provincial People's Hospital
- The First Affiliated Hospital of Xi'an Jiaotong University
- Shaanxi Provincial People's Hospital
- West China Hospital Sichuan University
- SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos
- People's Hospital of Xinjiang Uygur Autonomous Region
- The First Affiliated Hospital of Xinjiang Medical University
- 1st Affiliated Hospital of College Medicine, Zhejiang Univ.
- Beijing Anzhen Hospital, Capital Medical University
- Beijing Friendship Hospital, Capital Medical University
- Beijing Tsinghua Changgung Hospital
- Shanghai East Hospital Affiated to Tongji University
- Shanghai Tongji Hospital of Tongji University
- Tianjin People's Hospital
- Hospital General de Medellin
- Rodrigo Botero S.A.S
- Servicios de Salud Universidad de Antioquia
- Sociedad Médica Rionegro SOMER S.A.
- Clínica de la Costa SAS
- IPS Centro Cientifico Asistencial S.A.S
- Corazón IPS S.A.S.
- Caja de Compensación Familiar CAFAM
- Fundación Cardiomet CEQUIN Eje Cafetero
- Instituto del Corazón de Bucaramanga
- Mediservis del Tolima IPS S.A.S
- IPS Centro Médico Imbanaco de Cali S.A.
- Fundacio del Caribe para la Investigacio Bio-Medica (BIOS)
- Fundación Cardioinfantil
- Hospital Universitario Clínica San Rafael
- Hospital San Vicente Fundación
- Fundacion Cardiovascular Santa Maria
- Hospital Universitario de San Ignacio
- Kardiologie MUDr. Libor Nechvatal s.r.o.
- Kardiologicka ambulance Brno s.r.o.
- Fakultni nemocnice Brno
- Kardiologicka ambulance
- Kardio Chlumec s.r.o.- Kardiologická ambulance
- Poliklinika Dolni Brezany
- Fakultni Nemocnice Hradec Kralove
- LUNACOR, Centrum pro choroby srdce a cev
- Kromerizska nemocnice a.s.
- Krajska Nemocnice Liberec
- KardioBusak s.r.o.
- Kardiologicka a interni ambulance
- Fakultni nemocnice Plzen
- Polabska zdravotni, s.r.o.
- Affidea Praha s.r.o
- Vseobecna fakultni nemocnice v Praze
- Institut Klinicke a Experimentalni Mediciny
- Fakultni nemocnice v Motole
- Ustredni vojenska nemocnice Praha
- Kardio s.r.o.
- Nemocnice Podlesi
- Angiocor s.r.o.
- Nemocnice Znojmo
- Aarhus Universitetshospital, Skejby
- Sydvestjysk Sygehus Esbjerg | Kardiologisk Forskningsenhed
- Capital Region | Gentofte Hospital - Cardiology Research
- Capital Region | Herlev Hospital - Department of Heart Disease
- Region Midtjylland | Regionshospitalet Godstrup - Clinic for Heart Research
- Holbæk Sygehus
- Hvidovre Hospital
- Regionshospitalet Randers
- Odense University Hospital | Svendborg Hospital - Cardiovascular Research Unit
- HUS Jorvin sairaala
- Tampereen yliopistollinen sairaala, keskussairaala
- Turun yliopistollinen keskussairaala
- Herzklinik Ulm GbR
- Klinikum der Universität Würzburg
- Medizinische Hochschule Hannover (MHH)
- Städt. Kliniken Bielefeld gGmbH
- Sana-Klinikum Remscheid GmbH
- Forschungszentrum Ruhr - KliFoCenter GmbH
- KAT General Hospital of Athens
- University General Hospital of Alexandroupolis
- General Hosp of Athens "Korgialenio-Benakeio" RCH
- HIPPOKRATION General Hospital of Athens
- G. GENNIMATAS General State Hospital of Athens
- General Hospital of Athens "ALEXANDRA"
- University General Hospital ATTIKON
- University General Hospital of Heraklion
- University General Hospital of Larissa
- Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
- University General Hospital of Patra
- Hippokration General Hospital of Thessaloniki
- Prince of Wales Hospital Hong Kong
- Queen Mary Hospital
- Queen Elizabeth Hospital Hong Kong
- Princess Margaret Hospital
- Cardiomobile Egeszsegugyi Szolgaltato Kft.
- Budai Irgalmasrendi Korhaz
- University of Semmelweis/ Semmelweis Egyetem
- University of Semmelweis/ Semmelweis Egyetem
- Uzsoki Utcai Korhaz
- Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
- Eszak-Pesti Centrumkorhaz-Honvedkorhaz
- Bugat Pal Korhaz
- Pharma4Trial Kft.
- Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely
- Borsod-Abauj-Zemplen Varmegyei Korhaz es Egyetemi Oktatokorhaz
- Kanizsai Dorottya Hospital
- Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.
- Coromed Smo Kft
- Da Vinci Maganklinika
- SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
- Tolna Varmegyei Balassa Janos Korhaz
- Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz
- Max Super Speciality Hospital, Saket
- Safdarjung Hospital
- Deenanath Mangeshkar Hospital
- KEM hospital
- Madras Medical Mission Institute
- Assuta Ashdod
- Barzilai Ashkelon University Medical Center | Cardiology Department
- Rambam Health Corporation
- Bnai Zion Medical Center
- Lady Davis Carmel Medical Center
- Hadassah Hebrew University Hospital Ein Kerem
- Meir Medical Center
- Health Corporation of Galilee Medical Center
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Tel-Aviv Sourasky Medical Center
- Poriya Medical Center | Cardiology Department
- Health Corporation of the Ziv Medical Center (R.A.)
- Shamir Medical Center (Assaf Harofeh)
- A.O.U. Mater Domini
- A.O.U. Policlinico Federico II Napoli
- AUSL di Bologna
- A.O.U. di Bologna Policlinico S.Orsola Malpighi
- A.O.U. di Ferrara
- AUSL di Piacenza
- ASST Papa Giovanni XXIII
- ASST del Garda
- ASST Spedali Civili di Brescia
- ASST di Cremona
- Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
- IRCCS Centro Cardiologico Monzino S.p.A
- IRCCS Istituti Clinici Scientifici Maugeri SpA SB
- ASST di Monza
- ASST della Brianza
- Fondazione IRCCS Policlinico San Matteo
- ASST Sette Laghi
- A.O.U. Maggiore della Carità
- AUSL Toscana Sud-Est
- A.O.U. Senese
- A.O. di Perugia
- A.O.U.I. Verona
- Kasugai Municipal Hospital
- TOYOTA Memorial Hospital
- Funabashi Municipal Medical Center
- Steel Memorial Yawata Hospital
- Onga Nakama Medical Association Onga Hospital
- Ogaki Municipal Hospital
- Shobara Red Cross Hospital
- Hyogo Prefectural Harima-Himeji General Medical Center
- National Hospital Organization Kobe Medical Center
- Higashi Takarazuka Satoh Hospital
- JA Toride Medical Center
- Public Central Hospital of Matto Ishikawa
- National Hospital Organization Kanazawa Medical Center
- Iwate Prefectural Central Hospital
- Mitoyo General Hospital
- Kagawa Prefectural Central Hospital
- Kitasato University Hospital
- Sagamihara Kyodo Hospital
- Japan Red Cross Society Azumino Hospital
- National Hospital Organization Shinshu Ueda Medical Center
- R.I.A.C Naha City Hospital
- Kishiwada Tokushukai Hospital
- Takatsuki Red Cross Hospital
- Ageo Central General Hospital
- Kawaguchi Cardiovascular and Respiratory Hospital
- Saitama Sekishinkai Hospital
- National Hospital Organization Hamada Medical Center
- Nishiarai Heart Central Clinic
- Minamino Cardiovascular Hospital
- National Hospital Organization Tokyo Medical Center
- Toho University Omori Medical Center
- Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
- National Hospital Organization Iwakuni Clinical Center
- JCHO Shimonoseki Medical Center
- Fukuoka University Nishijin Hospital
- Gifu Prefectural General Medical Center
- National Hospital Organization Kumamoto Medical Center
- Kumamoto University Hospital
- Miyazaki Medical Association Hospital
- Shinrakuen Hospital
- Oita Prefectural Hospital
- The Sakakibara Heart Institute of Okayama
- Osaka Police Hospital
- Osaka General Medical Center
- Social Corporation Keigakukai Minamiosaka Hospital
- Toyama University Hospital
- Seiyu Memorial Hospital
- Chungbuk National University Hospital
- Yonsei University Wonju Christian Hospital
- Hallym University Sacred Heart Hospital
- Bundang Cha Hospital
- Pusan National University Hospital
- Dong-A University Hospital
- Chung Nam National University Hospital
- Chonnam National University Hospital
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Daugavpils Regional Hospital
- Jelgava Outpatient Clinic
- Liepaja Regional Hospital
- 1st Riga Clinical Hospital
- P. Stradins Clinical University Hospital
- GK Neiroklinika
- Gita Rancane - cardiology private practice
- UAB "Klinikiniai sprendimai" Alytus
- LUHS Kauno Hospital (Laisves ave.)
- LUHS Kauno Hospital (Josvainiu str.)
- Saules family medicine center
- Klaipeda Seamen's Hospital
- Siauliai Republican hospital
- Vilnius University Hospital Santaros Klinikos
- Institute Jantung Negara
- University Malaya Medical Centre
- Hospital Raja Permaisuri Bainun
- Gleneagles Penang Medical Center
- Hospital Pulau Pinang
- Sarawak Heart Centre
- Hospital Serdang
- Centro de Investigación Médica Dr. Alberto Bazzoni SA de CV
- Fundación de Atencion e Investigacion Medica Lindavista SC
- Hospital de Jesús
- Hospital General de Acapulco
- Consultorio de Medicina Especializada del Sector Privado
- Centro de Estudios Clinicos de Queretaro S. C. (CECLIQ)
- Hospital Ángeles de Xalapa
- Hospital Cardiologica Aguascalientes
- Centro de Investigacion y Atencion Integral Durango S.C.
- Ziekenhuis Groep Twente
- Tergooiziekenhuizen-Blaricum
- Deventer Ziekenhuis
- Slingeland Ziekenhuis
- Ziekenhuis Gelderse Vallei
- Catharina Ziekenhuis
- Universitair Medisch Centrum Groningen
- Ziekenhuis St. Jansdal
- Maastricht UMC
- Diaconessenhuis Meppel
- Antonius Ziekenhuis Sneek
- Maxima Medisch Centrum, locatie Veldhoven
- University of Auckland
- Christchurch Heart Institute
- Dunedin Hospital
- P3 Research Ltd Hawkes Bay
- Hutt Hospital
- Nelson Hospital
- P3 Research
- MICS Centrum Medyczne Bydgoszcz
- KLIMED Marek Klimkiewicz
- Uniwersyteckie Centrum Medycyny Morskiej i Tropikalnej
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni
- CLINICAL MEDICAL RESEARCH Sp. z o. o.
- Unicardia Specjalistyczne Centrum Leczenia Ch.Serca i Naczyn
- IMEDICA Centrum Medyczne
- NZOZ "Twoja Przychodnia" Sp. z o.o.
- Zechowicz Medeusz-Plus Lekarska Spolka Partnerska
- Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
- Uniwersytecki Szpital Kliniczny w Poznaniu
- Szpital Specjalistyczny SPZOZ
- NZOZ Pro-Cordis Sopockie Centrum Badan Kardiologicznych
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- Gessek Jacek Prywatny Gabinet Lekarski
- Hospital da Senhora da Oliveira | Clinical Research Department
- Centro Hospitalar Universitario Cova de Beira | Clinical Research Department
- ULSM - Hospital Pedro Hispano
- Hospital da Luz - Setubal
- Hospital Prof. Dr. Fernando Fonseca
- BlueClinical | Centro Hospitalar Baixo Vouga - Unidade Aveiro - Gabinete de Ensaios Clinicos
- Centro Hospitalar e Universitario de Coimbra, E.P.E. | Department of Cardiology, Research Unit
- ULSG - Unidade Local de Saude da Guarda
- Centro Hospitalar de Leiria | Santo Andre Hospital - Research Center
- Centro Hospitalar de Lisboa Ocidental | Clin Res Dept
- Hospital da Luz - Lisboa
- Centro Hospitalar Universitario do Porto
- CMI. Dr. Podoleanu Cristian
- Spitalul Clinic Municipal de Urgenta "Timisoara"
- Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare
- Emergency County Hospital, Braila
- S.C Thera Card S.R.L
- Emergency Institute for Cardiovascular Diseases
- Spitatul Universitar de Urgenta Bucuresti
- Emergency Institute for Cardiovascular Diseases
- Spitalul Clinic de Urgenta "Sf. Pantelimon"
- Emergency Clinical County Hospital Craiova
- Sf. Ap. Andrei Emergency Clinical County Hospital Galati
- S.C. CARDIOMED S.R.L. Iasi
- S.C. Sal Med SRL
- S.C. Cardio Med S.R.L.
- Municipal Clinical Emergency Hospital of Timisoara
- Timisoara Institute of Cardiovascular Diseases
- SBHI of Sverdlovsk Region Aramil City Hospital
- First City Clinical Hospital n.a. E.E. Volosevich
- Altai Regional Cardiological Dispensary
- SBEI "Chita State Medical Academy"
- Izhevsk City Clinical Hospital #9
- Kazan Federal University
- Clinical Diagnostic Center
- Sci-Res. Institute of Complex Cardiovascular Disorders
- Center of cardiology and neurology
- Research center of therapy and prophylactic medicine
- City clinical hospital n.a. V.V. Vinogradov
- Moscow State University n.a. M.V. Lomonosov
- City Clinical Hospital #51
- Russian Clinical and Research Center of Gerontology
- State Novosibirsk Regional Clinical Hospital
- Omsk Region "Clinical Health Unit No. 9"
- Penza Regional Clinical Hospital n.a. N.N. Burdenko
- Perm Regional Hospital for War Veterans
- Rostov-on-Don Emergency Clinical Hospital
- SBI of the Ryazan region "Regional clinical hospital"
- Samara Regional Clinical Cardiology Dispensary n.a. Polyakov
- Clinical Hospital #3 n.a. S.R. Mirotvortsev
- Scien. Res. Inst. of Emergency Care n.a. I.I. Dzhanelidze
- St. Petersburg Clinical Hospital of RAS
- LLC Astarta
- Scientific Research Institute of Cardiology
- Tomsk Regional Clinical Hospital
- Sverdlovsk Regional Clinical Hospital #1
- Stredoslovensky ustav srdcovych a cievnych chorob, a.s.
- ALIAN s.r.o.
- Narodny ustav srdcovych a cievnych chorob, a.s
- Nemocnica svateho Michala, a.s.
- Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto
- Centrum interv. neuroradiologie a endovaskularnej liecby
- Kardiosanus | Bratislava, Slovakia
- Nemocnica s poliklinikou Brezno, n.o.
- Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho
- JG-COR s.r.o.
- Medical Group Kosice s.r.o. | Kosice, Slovakia
- KARDIO-ANGIO s.r.o.
- KardioMed s.r.o.
- MEDI M&M, s.r.o.
- Kardiocentrum Nitra | Cardiology Clinic - Outpatient Department
- KARDIOMED NZ s.r.o.
- MEDISPOL s.r.o.
- COR, s.r.o
- Medivasa s.r.o.
- Complejo Hospitalario Universitario de Ferrol | Hospital Naval - Unidad de Hipertensión Arterial
- Hospital del Servei Valencià de Salud de la Vega Baja
- Hospital Central de Asturias
- Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
- Hospital Santa María del Puerto
- Jose Manuel Pascual Pascual S.A. | Hospital Virgen del Camino - Internal Medicine Department
- Jose Manuel Pascual Pascual S.A. | Hospital Virgen de las Montanas - Internal Medicine Department
- Hospital Dr. Negrín
- Hospital Universitario Virgen de la Victoria | Cardiology Department
- Hospital Alta Resolucion de Utrera | Cardiology Service Department
- Hospital San Rafael
- Hospital del Mar
- Ciutat Sanitaria i Universitaria de la Vall d'Hebron
- Hospital Universitario Virgen de las Nieves|Cardiologia
- Hospital Universitario Arnau de Vilanova de Lleida
- Hospital Sanitas La Zarzuela | Cardiologia
- Hospital Ramón y Cajal | Medicina Interna
- Hospital Universitario 12 de Octubre
- Complejo Hospitalario Ntra. Sra. de Valme
- Hospital Clínico Universitario de Valencia
- Hospital General Universitario de Valencia
- La Fe University and Polytechnic Hospital | Cardiology Department
- Hospital de Manises
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Changhua Christian Hospital
- Mackay Memorial Hospital - Hsinchu Branch
- Taichung Veterans General Hospital
- National Taiwan University Hospital
- Taipei Medical University Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital at Linkou
- Afyonkarahisar Saglik Bilimleri Universitesi
- Saglik Bilimleri Universitesi Antalya EA Hastanesi
- Trakya Univ. Tip Fak.
- Eskisehir Osmangazi Universitesi Tip Fakultesi
- Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
- Istanbul Universitesi Kardiyoloji Enstitusu
- Istanbul Mehmet Akif Ersoy Gogus Kalp Damar Cerrahisi E.A.H.
- Dokuz Eylul Universitesi Tip Fakultesi
- Erciyes Universitesi Tip Fakultesi
- Kocaeli Universitesi Tip Fakultesi
- Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
- Kutahya Saglik Bilimleri Uni. Evliya Celebi Egitim ve Arasti
- Mersin Universitesi Tip Fakultesi
- Cherkasy Regional Cardiological Center
- "Clinical Emergency Hospital" of Dnipro City Council
- National Institute of Therapy named after L.T.Maloyi
- Regional Dispensary of Radiation Protection of Population
- Miska Klinichna likarnya No 8
- City Clinical Hospital # 1
- Institute of Cardiology AMS
- Medbud-Clinic LLC
- Railway Clinical Hospital #2
- LLC Medical Centre CONSILIUM MEDICAL
- Lviv regional clinical medical & diagnostic cardiology cente
- Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
- Zakarpatsky Oblasnyi Kardiologichnyi Dyspanser
- Vinnytsia City Clinical Hospital #1
- Regional Clinical Hospital - Vinnytsya
- Regional medical center of cardio-vascular disease
- Zaporizhia Municipal Clinical Hospital No.10
- Zaporizhzhya City Emergency Care Hospital
- Communal Institution Central City Hospital 1 of Zhytomyr
- Royal Bournemouth General Hospital
- Poole Hospital NHS Trust
- Queen Elizabeth University Hospital
- North Hampshire Hospital
- Lister Hospital
- Blackpool Victoria Hospital
- University Hospitals Leicester
- Wansbeck General Hospital
- Russells Hall Hospital
- St Richard's Hospital
- Castle Hill Hospital
- Glasgow Royal Infirmary | Glasgow Clinical Research Facility
- Manchester Royal Infirmary
- Great Western Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm 1_BAY94-8862
Arm 2_Placebo
Adult patients receive BAY94-8862
Adult patients receive placebo