Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial
— VICTOROfficial title:
A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction
| Verified date | February 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.
| Status | Active, not recruiting |
| Enrollment | 6000 |
| Est. completion date | June 15, 2025 |
| Est. primary completion date | March 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - History of chronic HF [New York Heart Association (NYHA) Class II to IV] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization. - Left ventricular ejection fraction (LVEF) of =40%, assessed within 12 months before randomization by any imaging method. - Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels. - A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention. Exclusion Criteria: - Has SBP <100 mm Hg or symptomatic hypotension. - Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device. - Amyloidosis or sarcoidosis. - Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization. - Hypertrophic cardiomyopathy. - Acute myocarditis or Takotsubo cardiomyopathy. - History of heart transplant. - Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia. - Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization. - History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization. - Malignancy or other noncardiac condition limiting life expectancy to <3 years. - Requires continuous home oxygen for severe pulmonary disease. - Interstitial lung disease. - Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization. - Recent history (within the last year) of drug or alcohol abuse or dependence. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Médico Viamonte-Clinical Research ( Site 4361) | Buenos Aires | Caba |
| Argentina | CEDIC ( Site 4363) | Caba | Buenos Aires |
| Argentina | Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 4352) | Ciudad Autónoma de Buenos Aires | Buenos Aires |
| Argentina | DIM Clínica Privada ( Site 4359) | Ramos Mejía | Buenos Aires |
| Argentina | Fundacion Estudios Clinicos ( Site 4356) | Rosario | Santa Fe |
| Argentina | Centro de Investigaciones Clinicas del Litoral ( Site 4354) | Santa Fe | |
| Argentina | Instituto de Investigaciones Clinicas Zarate ( Site 4360) | Zárate | Buenos Aires |
| Australia | Royal Adelaide Hospital-Cardiology ( Site 0456) | Adelaide | South Australia |
| Australia | Flinders Medical Centre-Cardiology Research ( Site 0455) | Bedford Park | South Australia |
| Australia | Core Research Group ( Site 0452) | Brisbane | Queensland |
| Australia | Royal Brisbane and Women's Hospital-Cardiology Research ( Site 0453) | Brisbane | Queensland |
| Australia | The Prince Charles Hospital-Cardiology Research Centre ( Site 0451) | Brisbane | Queensland |
| Australia | St. John of God Subiaco Hospital ( Site 0457) | Subiaco | Western Australia |
| Austria | Krankenhaus St. Josef Braunau ( Site 0354) | Braunau | Oberosterreich |
| Austria | Medizinische Universität Graz-Department of Cardiology ( Site 0351) | Graz | Steiermark |
| Austria | Uniklinikum Salzburg-Universitätsklinik für Innere Medizin II, Kardiologie, Internistische Intensiv | Salzburg | |
| Austria | Imed19-privat ( Site 0353) | Vienna | Wien |
| Austria | Klinik Floridsdorf-Karl Landsteiner Institute for Cardiovascular and Critical Care Research c/o Dep | Wien | |
| Brazil | Centro de Pesquisa Clinica do Coracao ( Site 0561) | Acaraju | Sergipe |
| Brazil | Instituto de Pesquisa clinica de Campinas ( Site 0551) | Campinas | Sao Paulo |
| Brazil | PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR ( Site 0555) | Curitiba | Parana |
| Brazil | Hospital de Messejana Dr Carlos Alberto Studart Gomes ( Site 0560) | Fortaleza | Ceara |
| Brazil | Universidade Federal de Goias-Serviço de Cardiologia ( Site 0553) | Goiania | Goias |
| Brazil | Hospital Mae de Deus ( Site 0564) | Porto Alegre | Rio Grande Do Sul |
| Brazil | CAPED Centro Avancado Pesquisa e Diagnostica ( Site 0552) | Ribeirao Preto | Sao Paulo |
| Brazil | Hospital de Clínicas de Ribeirão Preto ( Site 0559) | Ribeirão Preto | Sao Paulo |
| Brazil | Hospital Pro-Cardiaco ( Site 0556) | Rio de Janeiro | |
| Brazil | Incor - Instituto do Coracao ( Site 0557) | Sao Paulo | |
| Canada | Heritage Medical Research Clinic ( Site 0679) | Calgary | Alberta |
| Canada | Cambridge Cardiac Care Centre ( Site 0658) | Cambridge | Ontario |
| Canada | University Of Alberta Hospital ( Site 0669) | Edmonton | Alberta |
| Canada | NSHA-QEII Health Sciences Centre-Dickson Bldg-Cardiology ( Site 0664) | Halifax | Nova Scotia |
| Canada | Hôpital de la Cité-de-la-Santé ( Site 0673) | Laval | Quebec |
| Canada | G A Research Associates ( Site 0652) | Moncton | New Brunswick |
| Canada | Institut de Cardiologie de Montreal ( Site 0661) | Montreal | Quebec |
| Canada | Montreal General Hospital ( Site 0653) | Montreal | Quebec |
| Canada | PACE Cardiology ( Site 0675) | Newmarket | Ontario |
| Canada | North York Diagnostic and Cardiac Centre ( Site 0682) | North York | Ontario |
| Canada | Oakville Cardiovascular Research LP ( Site 0657) | Oakville | Ontario |
| Canada | Private Practice - Dr. James Cha ( Site 0655) | Oshawa | Ontario |
| Canada | Kawartha Cardiology Clinical Trials ( Site 0654) | Peterborough | Ontario |
| Canada | Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer | Sherbrooke | Quebec |
| Canada | Unité de Recherche Clinique du CISSS des Laurentides ( Site 0668) | St-Jerome | Quebec |
| Canada | Hopital Pierre-Le Gardeur ( Site 0674) | Terrebonne | Quebec |
| Canada | Corcare-Corcare Cardiovascular Research ( Site 0660) | Toronto | Ontario |
| Canada | Medicus MFC Research Clinic ( Site 0676) | Toronto | Ontario |
| Canada | Diex Recherche Trois-Rivieres ( Site 0677) | Trois-Rivieres | Quebec |
| Canada | Victoria Heart Institute Foundation ( Site 0680) | Victoria | British Columbia |
| Canada | St. Boniface General Hospital ( Site 0667) | Winnipeg | Manitoba |
| Chile | IC La Serena Research ( Site 0769) | La Serena | Coquimbo |
| Chile | Clinica Alemana Osorno ( Site 0768) | Osorno | Los Lagos |
| Chile | Cardio Sur ( Site 0756) | Santiago | Region M. De Santiago |
| Chile | Clinica Dermacross ( Site 0760) | Santiago | Region M. De Santiago |
| Chile | Clínica Ensenada ( Site 0753) | Santiago | Region M. De Santiago |
| Chile | Enroll SpA ( Site 0755) | Santiago | Region M. De Santiago |
| Chile | Espacio Eme ( Site 0762) | Santiago | Region M. De Santiago |
| Chile | Hospital y CRS El Pino ( Site 0763) | Santiago | Region M. De Santiago |
| Chile | Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0754) | Santiago | Region M. De Santiago |
| Chile | Centro De Estudios Cardiologicos Y De Medicina Interna ( Site 0752) | Temuco | Araucania |
| Chile | Clinical Research Chile SpA ( Site 0761) | Valdivia | Los Rios |
| Chile | ONCOCENTRO APYS ( Site 0770) | Viña del Mar | Valparaiso |
| China | BAO TOU CENTRAL HOSPITAL ( Site 0866) | Bao Tou | Inner Mongolia |
| China | Aero Space Center Hospital ( Site 0918) | Beijing | Beijing |
| China | Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 0856) | Beijing | Beijing |
| China | Beijing Friendship Hospital-Cardology ( Site 0865) | Beijing | Beijing |
| China | Beijing Tsinghua Changgung Hospital ( Site 0911) | Beijing | Beijing |
| China | China-Japan Union Hospital-department of cardiology ( Site 0916) | Changchun | Jilin |
| China | Changsha Central Hospital ( Site 0854) | Changsha | Hunan |
| China | Hunan Provincial People's Hospital ( Site 0857) | ChangSha | Hunan |
| China | The Third Xiangya Hospital of Central South University-Cardiology ( Site 0860) | Changsha | Hunan |
| China | Xiangya Hospital Central South University-Cardiological Department ( Site 0899) | Changsha | Hunan |
| China | West China Hospital Sichuan University ( Site 0904) | Cheng Du | Sichuan |
| China | The Second Affiliated Hospital Chongqing Medical University-Department of Cardiology ( Site 0908) | Chongqing | Chongqing |
| China | The First People's Hospital of Foshan ( Site 0898) | Foshan | Guangdong |
| China | Guangdong Provincial People's Hospital-Cardiology ( Site 0852) | Guangzhou | Guangdong |
| China | Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Cardiology ( Site 0868) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Jinan University ( Site 0897) | Guangzhou | Guangdong |
| China | Hainan General Hospital ( Site 0894) | Haikou | Hainan |
| China | The First Affiliated Hospital, Zhejiang University ( Site 0907) | Hangzhou | Zhejiang |
| China | The Second Affiliated hospital of Zhejiang University school of medicine ( Site 0909) | Hangzhou | Zhejiang |
| China | Zhejiang Provincial People's Hospital ( Site 0914) | Hangzhou | Zhejiang |
| China | The First Hospital of Harbin Medical University-Cardiology ( Site 0903) | Harbin | Heilongjiang |
| China | Anhui Provincil Hospital South District ( Site 0920) | Hefei | Anhui |
| China | Lanzhou university second hospital-Lanzhou university second hospital ( Site 0863) | Lanzhou | Gansu |
| China | People's Hospital of Lishui City-department of cardiovascular ( Site 0862) | Lishui | Zhejiang |
| China | The Second Affiliated Hospital of Nanchang University-Cardiology ( Site 0912) | Nanchang | Jiangxi |
| China | Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Cardiolggy | Nanjing | Jiangsu |
| China | The Second Affiliated Hospital of Nanjing Medical University-Cardiology ( Site 0900) | Nanjing | Jiangsu |
| China | Shanghai Jiaotong University School of Medicine Ruijin Hospital-Cardiology Department ( Site 0855) | Shanghai | Shanghai |
| China | Shanghai Tongji Hospital-Cardiovascular Department ( Site 0905) | Shanghai | Shanghai |
| China | Shanghai Xuhui Central Hospital-Cardiovascular Department ( Site 0872) | Shanghai | Shanghai |
| China | Shanghai Yangpu District Central Hospital-Cardiology ( Site 0876) | Shanghai | Shanghai |
| China | Zhongshan Hospital,Fudan University-Cardiology ( Site 0851) | Shanghai | Shanghai |
| China | The People's Hospital of Liaoning Province ( Site 0859) | Shenyang | Liaoning |
| China | The University of Hong Kong - Shenzhen Hospital-Cardiovascular department ( Site 0895) | Shenzhen | Guangdong |
| China | Siping Central People's Hospital-Cardiovascular Department ( Site 0915) | Siping | Jilin |
| China | The Second Hospital of Tianjin Medical University-Endocrinology ( Site 0902) | Tianjin | Tianjin |
| China | Tianjin Chest Hospital-Cardiology ( Site 0901) | Tianjin | Tianjin |
| China | Tianjin People' s Hospital ( Site 0867) | Tianjin | Tianjin |
| China | Chongqing Three Gorges Central Hospital ( Site 0913) | Wanzhou | Chongqing |
| China | The First Affiliated Hospital of Wenzhou Medical University-Vasculocardiology Department ( Site 0874 | Wenzhou | Zhejiang |
| China | Wuhan Union Hospital ( Site 0919) | Wuhan | Hubei |
| China | Wuxi No.2 People's Hospital-Cardiology Department ( Site 0877) | Wuxi | Jiangsu |
| China | Wuxi People's Hospital-Cardiovascular Department ( Site 0870) | Wuxi | Jiangsu |
| China | The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit | Xi'an | Shaanxi |
| China | Shaanxi provincial people's hospital ( Site 0853) | Xian | Shaanxi |
| China | The Affiliated Hospital of Xuzhou Medical College ( Site 0910) | Xuzhou | Jiangsu |
| China | Northern Jiangsu People's Hospital ( Site 0861) | Yangzhou | Jiangsu |
| China | Affiliated Hospital of Jiangsu University-Cardiology Department ( Site 0917) | Zhenjiang | Jiangsu |
| Colombia | Clinica de la Costa S.A.S. ( Site 0954) | Barranquilla | Atlantico |
| Colombia | Corazon IPS ( Site 0964) | Barranquilla | Atlantico |
| Colombia | IPS Centro Científico Asistencial S.A.S ( Site 0952) | Barranquilla | Atlantico |
| Colombia | Instituto Del Corazón De Bucaramanga ( Site 0960) | Bucaramanga | Santander |
| Colombia | Centro de Investigaciones Clinicas SAS ( Site 0957) | Cali | Valle Del Cauca |
| Colombia | Clínica Imbanaco S.A.S ( Site 0963) | Cali | Valle Del Cauca |
| Colombia | Fundacion Valle del Lili- CIC-Internal Medicine ( Site 0962) | Cali | Valle Del Cauca |
| Colombia | IPS Médicos Internistas de Caldas ( Site 0959) | Manizales | Caldas |
| Colombia | Centro Cardiovascular Colombiano Clínica Santa María ( Site 0951) | Medellín | Antioquia |
| Colombia | Fundación Centro de Investigación Clínica CIC ( Site 0955) | Medellín | Antioquia |
| Colombia | Rodrigo Botero S.A.S ( Site 0953) | Medellín | Antioquia |
| Colombia | Fundación Cardiovascular de Colombia ( Site 0961) | Piedecuesta | Santander |
| Czechia | Fakultní nemocnice Brno Bohunice-Interni kardiologicka klinika ( Site 1058) | Brno | Brno-mesto |
| Czechia | Fakultni Nemocnice u sv. Anny v Brne-I. interni kardioangiologicka klinika ( Site 1066) | Brno | Jihomoravsky Kraj |
| Czechia | MUDr. Libor Nechvatal s.r.o. , Kardiologie ( Site 1057) | Brno | Jihomoravsky Kraj |
| Czechia | Vojenská Nemocnice Brno-Internal department ( Site 1055) | Brno | Brno-mesto |
| Czechia | KardioBusak s.r.o. ( Site 1051) | Louny | |
| Czechia | Klinika Dr. Pirka ( Site 1065) | Mladá Boleslav | Mlada Boleslav |
| Czechia | Institut Klinicke a Experimentalni Mediciny-Klinika kardiologie ( Site 1052) | Prague | Praha 4 |
| Czechia | Ustredni vojenska nemocnice-Oddeleni kardiologie ( Site 1054) | Praha | Praha 6 |
| Czechia | Vseobecna fakultni nemocnice v Praze-Centrum srdecního selhání ( Site 1059) | Praha 2 | |
| Czechia | Nemocnice Slany-Interna - kardiologicka ambulance ( Site 1063) | Slany | Stredocesky Kraj |
| Czechia | KIGE ( Site 1060) | Znojmo | |
| Denmark | Aarhus Universitetshospital, Skejby ( Site 1160) | Aarhus | Midtjylland |
| Denmark | Rigshospitalet-Cardiology ( Site 1161) | Copenhagen | Hovedstaden |
| Denmark | Amager Hospital ( Site 1163) | CPH | Hovedstaden |
| Denmark | Sydvestjysk Sygehus Esbjerg-Hjertemedicinsk Projekt ( Site 1154) | Esbjerg | Syddanmark |
| Denmark | Herlev and Gentofte Hospital-Department of Cardiology ( Site 1158) | Hellerup | Hovedstaden |
| Denmark | Nordsjællands Hospital - Hillerød ( Site 1159) | Hillerod | Hovedstaden |
| Denmark | Sygehus Vendsyssel Hjoerring ( Site 1164) | Hjorring | Nordjylland |
| Denmark | Holbæk Sygehus-Cardiology ( Site 1152) | Holbaek | Sjaelland |
| Denmark | Hvidovre Hospital-259 ( Site 1151) | Hvidovre | Hovedstaden |
| Denmark | Roskilde Sygehus ( Site 1162) | Roskilde | Sjaelland |
| Denmark | Slagelse Sygehus-Ambulatorium for Hjertesygdomme ( Site 1153) | Slagelse | Sjaelland |
| Denmark | Svendborg Hospital Odense Universitets hospital-Kardiologisk Forskningsenhed ( Site 1156) | Svendborg | Syddanmark |
| Denmark | Regionshospitalet Viborg ( Site 1166) | Viborg | Midtjylland |
| France | CHD Vendee ( Site 1361) | La Roche-sur-Yon | Vendee |
| France | Centre Hospitalier Louis Pasteur ( Site 1360) | Le Coudray | Eure-et-Loir |
| France | Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 1356) | Le Kremlin-Bicêtre | Paris |
| France | Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1364) | Lyon | Rhone |
| France | Centre Hospitalier Universitaire de Nice - Hopital Pasteur-Service cardiologie ( Site 1353) | Nice | Alpes-Maritimes |
| France | Pitie Salpetriere University Hospital ( Site 1363) | Paris | Ile-de-France |
| France | CHU Bordeaux Haut-Leveque ( Site 1362) | Pessac | Aquitaine |
| France | CHU Charles Nicolle ( Site 1354) | Rouen | Haute-Normandie |
| France | Centre Hospitalier intercommunal de Toulon La Seyne sur Mer ( Site 1352) | Toulon | Provence-Alpes-Cote-d Azur |
| France | CHU Rangueil-Cardiology ( Site 1351) | Toulouse | Haute-Garonne |
| France | Centre Hospitalier Régional Universitaire de Nancy - Hôpitau-Centre Investigation Clinique Plurithé | Vandoeuvre lès Nancy | Lorraine |
| Germany | Praxis Rankestrasse ( Site 1461) | Berlin | |
| Germany | Klinikum Coburg ( Site 1464) | Coburg | Bayern |
| Germany | St. Vinzenz-Hospital-Cardiology ( Site 1455) | Cologne | Nordrhein-Westfalen |
| Germany | Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien ( Site 1477) | Dresden | Sachsen |
| Germany | Herzzentrum Dresden GmbH Universitätsklinik ( Site 1469) | Dresden | Sachsen |
| Germany | Staedtisches Klinikum Dresden-2. Medizinische Klinik ( Site 1468) | Dresden | Sachsen |
| Germany | Katholisches Krankenhaus St. Johann Nepomuk ( Site 1462) | Erfurt | Thuringen |
| Germany | ClinPhenomics CVC GmbH ( Site 1457) | Frankfurt | Hessen |
| Germany | Klinikum Frankfurt Höchst ( Site 1463) | Frankfurt | Hessen |
| Germany | Universitätsmedizin Greifswald ( Site 1470) | Greifswald | Mecklenburg-Vorpommern |
| Germany | Cardiologicum Hamburg ( Site 1467) | Hamburg | |
| Germany | Medizinische Hochschule Hannover ( Site 1476) | Hannover | Niedersachsen |
| Germany | Universitaetsklinikum Heidelberg-Klinik für Kardiologie, Angiologie und Pneumologie ( Site 1475) | Heidelberg | Baden-Wurttemberg |
| Germany | Asklepios Klinik Langen ( Site 1473) | Langen | Hessen |
| Germany | Klinikum Leverkusen ( Site 1453) | Leverkusen | Nordrhein-Westfalen |
| Germany | Klinikum Ludwigshafen ( Site 1456) | Ludwigshafen | Rheinland-Pfalz |
| Germany | Kliniken Maria Hilf-Klinik für Kardiologie ( Site 1454) | Mönchengladbach | Nordrhein-Westfalen |
| Germany | Marienhaus Klinikum St. Elisabeth Neuwied ( Site 1452) | Neuwied | Rheinland-Pfalz |
| Germany | Kardiologische Gemeinschaftspraxis ( Site 1460) | Nuremberg | Bayern |
| Germany | Gemeinschaftspraxis Dr. Fabian Krämer, Dr. Ulrich Overhoff ( Site 1459) | Siegen | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Wuerzburg ( Site 1458) | Wuerzburg | Bayern |
| Greece | University Hospital of Alexandroupolis-First Department of Internal Medicine ( Site 1551) | Alexanroupolis | Evros |
| Greece | General Hospital of Athens "G. Gennimatas"-General Hospital of Athens "G.Gennimatas" ( Site 1561) | Athens | Attiki |
| Greece | General Hospital of Athens Hippokratio ( Site 1552) | Athens | Attiki |
| Greece | Konstantopoulio General Hospital-Cardiology Clinic ( Site 1553) | Athens | Attiki |
| Greece | Alexandra Hospital-HEART FAILURE AND CARDIO-ONCOLOGY UNIT ( Site 1559) | Athina | Attiki |
| Greece | ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1556) | Chaidari | Attiki |
| Greece | University Hospital of Ioannina-2nd Department of Cardiology ( Site 1554) | Ioannina | Dytiki Ellada |
| Greece | University General Hospital of Larissa ( Site 1555) | Larissa | Thessalia |
| Greece | Hygeia Hospital-6th cardiology clinic ( Site 1560) | Marousi | Attiki |
| Greece | AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 1558) | Thessaloniki | |
| Greece | European Interbalkan Medical Center-2nd Department of Cardiology ( Site 1557) | Thessaloniki | |
| Guatemala | Clinica Medica ( Site 1651) | Guatemala | |
| Guatemala | Unidad De Diagnostico Cardiologico ( Site 1654) | Guatemala | |
| Guatemala | Unidad De Diagnostico Cardiologico ( Site 1652) | Guatemala City | |
| Hong Kong | Grantham Hospital ( Site 1753) | Aberdeen | |
| Hong Kong | Queen Mary Hospital-Medicine - Cardiology ( Site 1752) | Hksar | |
| Hong Kong | Princess Margaret Hospital ( Site 1755) | Hong Kong | |
| Hong Kong | Prince of Wales Hospital ( Site 1751) | Shatin | |
| Hungary | DRC Gyógyszervizsgáló Központ ( Site 1869) | Balatonfüred | Veszprem |
| Hungary | Private Practice - Dr. Lakatos Ferenc ( Site 1854) | Békéscsaba | Bekes |
| Hungary | Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 1851) | Budapest | |
| Hungary | Óbudai Egészségügyi Centrum ( Site 1861) | Budapest | |
| Hungary | Semmelweis University-Városmajori Szív- és Érgyógyászati Klinika ( Site 1855) | Budapest | |
| Hungary | Szent Rókus Kórház ( Site 1858) | Budapest | |
| Hungary | Békés Megyei Központi Kórház Pándy Kálmán Tagkórház-Cardiology ( Site 1878) | Gyula | Bekes |
| Hungary | Bacs-Kiskun Megyei Korhaz-I. Belgyógyászat - Kardiológia ( Site 1873) | Kecskemét | Bacs-Kiskun |
| Hungary | Flor Ferenc Hospital of Pest County-5th Department of Internal Medicine ( Site 1852) | Kistarcsa | Pest |
| Hungary | TaNa Med ( Site 1866) | Mosonmagyaróvár | Gyor-Moson-Sopron |
| Hungary | Medifarma 98 Kft-Outpatient Clinic ( Site 1859) | Nyiregyhaza | |
| Hungary | CoroMed ( Site 1867) | Pécs | Baranya |
| Hungary | Pécsi Tudományegyetem Klinikai Központ ( Site 1865) | Pécs | Baranya |
| Hungary | Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1874) | Szeged | Csongrad |
| Hungary | CMed Rehabilitacios es Diagnosztikai Kozpont ( Site 1877) | Székesfehérvár | Szekesfehervar |
| Hungary | Tolna Megyei Balassa János Kórház ( Site 1868) | Szekszárd | Szekszard |
| Hungary | OEC Clinical Research - Zalaegerszeg ( Site 1864) | Zalaegerszeg | |
| Ireland | St. James's Hospital-Cardiology ( Site 1951) | Dublin | |
| Ireland | St. Michael's Hospital ( Site 1955) | Dun Laoghaire | Dublin |
| Israel | Assuta Ashdod Medical Center-Cardiology ( Site 2063) | Ashdod | |
| Israel | Hillel Yaffe Medical Center-Heart Institute ( Site 2058) | Hadera | |
| Israel | Rambam Health Care Campus-Cardiology ( Site 2053) | Haifa | |
| Israel | Hadassah Medical Center-Heart Institute ( Site 2062) | Jerusalem | |
| Israel | Shaare Zedek Medical Center-Cardiology ( Site 2055) | Jerusalem | |
| Israel | Galilee Medical Center-Cardiology ( Site 2051) | Nahariya | |
| Israel | Rabin Medical Center-Cardiology - CHF ( Site 2052) | Petah-Tikva | |
| Israel | Sheba Medical Center-Leviev Heart Center ( Site 2064) | Ramat Gan | |
| Israel | Kaplan Medical Center-Heart Institution ( Site 2054) | Rehovot | |
| Israel | Yitzhak Shamir Medical Center-Cardiology ( Site 2060) | Zerifin | |
| Italy | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII-Cardiologia 1 ( Site 2151) | Bergamo | |
| Italy | IRCCS - AOU di Bologna-Dept. of Medical and Surgical sciences ( Site 2158) | Bologna | |
| Italy | Azienda Ospedaliera Spedali Civili di Brescia-Cardiology- Day Hospital ( Site 2154) | Brescia | |
| Italy | Azienda Ospedaliero Universitaria S.Anna ( Site 2152) | Cona | Emilia-Romagna |
| Italy | ASST Grande Ospedale Metropolitano Niguarda-Unità Ricerche Cliniche della Cardiologia 4 ( Site 2159) | Milan | Milano |
| Italy | Centro Cardiologico Monzino-Heart Failure Unit ( Site 2153) | Milano | Lombardia |
| Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-U.O.C. Cardiologia ( Site 2161) | Milano | Lombardia |
| Italy | Fondazione IRCCS Policlinico San Matteo-Cardiology ( Site 2157) | Pavia | |
| Italy | University of Perugia ( Site 2164) | Perugia | |
| Italy | Policlinico Umberto I ( Site 2166) | Roma | Lazio |
| Italy | IRCCS San Raffaele Pisana-riabilitazione cardiologica ( Site 2156) | Rome | Roma |
| Italy | ospedale le scotte ( Site 2163) | Siena | Toscana |
| Italy | Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino ( Site 2165) | Torino | |
| Italy | Cattinara Hospital-Cardiovascular Department ( Site 2162) | Trieste | Friuli-Venezia Giulia |
| Korea, Republic of | Hallym University Sacred Heart Hospital-Cardiovascular center ( Site 3556) | Anyang-si | Kyonggi-do |
| Korea, Republic of | Pusan National University Hospital-Internal Medicine ( Site 3553) | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Chungbuk National University Hospital-Internal medicine ( Site 3551) | Cheongju-si | Chungbuk |
| Korea, Republic of | Chonnam National University Hospital ( Site 3558) | Gwangju-si | Kwangju-Kwangyokshi |
| Korea, Republic of | Chungnam national university hospital ( Site 3554) | Jung-gu | Taejon-Kwangyokshi |
| Korea, Republic of | Gachon University Gil Medical Center ( Site 3559) | Namdong-gu | Incheon |
| Korea, Republic of | Seoul National University Hospital ( Site 3557) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System ( Site 3552) | Seoul | |
| Korea, Republic of | Yonsei University-Wonju Severance Christian Hospital ( Site 3555) | Wonju | Kang-won-do |
| Malaysia | Hospital Sultanah Bahiyah-Department of Cardiology ( Site 2355) | Alor Setar | Kedah |
| Malaysia | Hospital Queen Elizabeth II ( Site 2359) | Kota Kinabalu | Sabah |
| Malaysia | Sarawak Heart Centre ( Site 2352) | Kota Samarahan | Sarawak |
| Malaysia | Hospital Sultanah Nur Zahirah-Jabatan Perubatan ( Site 2360) | Kuala Terengganu | Terengganu |
| Malaysia | Hospital Tengku Ampuan Afzan ( Site 2353) | Kuantan | Pahang |
| Malaysia | Hospital Universiti Sains Malaysia-Medical Department ( Site 2357) | Kubang Kerian | Kelantan |
| Malaysia | University Malaya Medical Centre ( Site 2351) | Lembah Pantai | Kuala Lumpur |
| Malaysia | UiTM Sungai Buloh Campus ( Site 2354) | Sungai Buloh | Selangor |
| Mexico | Hospital General de Acapulco ( Site 2469) | Acapulco | Guerrero |
| Mexico | Fundación Cardiovascular de Aguascalientes A.C. ( Site 2473) | Aguascalientes | |
| Mexico | Medivest Centro de Investigación Integral ( Site 2460) | Chihuahua City | Chihuahua |
| Mexico | Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2468) | Ciudad Madero | Tamaulipas |
| Mexico | Cardiocent de Guadalajara S.C. ( Site 2464) | Guadalajara | Jalisco |
| Mexico | Instituto Jalisciense de Metabolismo SC ( Site 2467) | Guadalajara | Jalisco |
| Mexico | Unidad de Investigaci?n Cl?nica Cardiometabolica de Occidente ( Site 2466) | Guadalajara | Jalisco |
| Mexico | Centro de Estudios de Alta Especialidad de Sinaloa ( Site 2463) | Mazatlán | Sinaloa |
| Mexico | Medical Care and Research SA de CV ( Site 2461) | Merida | Yucatan |
| Mexico | Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2454) | Mexico | Distrito Federal |
| Mexico | HOSPITAL GENERAL DE MEXICO DR. EDUARDO LICEAGA ( Site 2478) | México | Distrito Federal |
| Mexico | Centro de Imagen y Tecnología en Intervención Cardiovascular ( Site 2477) | Mexico City | Distrito Federal |
| Mexico | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 2474) | Mexico City | Distrito Federal |
| Mexico | Unidad biomedica avanzada monterrey ( Site 2462) | Monterrey | Nuevo Leon |
| Mexico | Centro de Investigacion Clinica de Oaxaca ( Site 2457) | Oaxaca | |
| Mexico | Oaxaca Site Management Organization ( Site 2459) | Oaxaca | |
| Mexico | Grupo Ollin Care ( Site 2476) | Pachuca | Hidalgo |
| Mexico | Centro de Atención e Investigación Cardiovascular del Potosí ( Site 2453) | San Luis Potosí | San Luis Potosi |
| Mexico | Unidad Médica para la Salud Integral ( Site 2472) | San Nicolás de los Garza | Nuevo Leon |
| Mexico | Centro de Investigacion Cardiovascular y Metabólica ( Site 2465) | Tijuana | Baja California |
| Mexico | CIMAB SA de CV ( Site 2456) | Torreon | Coahuila |
| Mexico | Consultorio de Medicina Especilizada del Sector Privado ( Site 2455) | Xalapa | Veracruz |
| Mexico | Hospital Angeles Xalapa ( Site 2451) | Xalapa-Enríquez | Veracruz |
| New Zealand | Auckland City Hospital ( Site 2659) | Auckland | |
| New Zealand | Middlemore Clinical Trials ( Site 2658) | Auckland | |
| New Zealand | North Shore Hospital-Cardiology Research ( Site 2656) | Auckland | |
| New Zealand | Christchurch Heart Institute ( Site 2651) | Christchurch | Canterbury |
| New Zealand | Dunedin Hospital-Cardiology Department ( Site 2653) | Dunedin | Otago |
| New Zealand | Waikato Hospital-Cardiology Clinical Trials Unit ( Site 2654) | Hamilton | Waikato |
| New Zealand | Hutt Valley District Health board HVDHB-Cardiology Research Unit ( Site 2652) | Lower Hutt | Wellington |
| Peru | Hospital Alberto Sabogal Sologuren ( Site 2851) | Bellavista | Qallaw |
| Peru | Instituto Nacional Cardiovascular INCOR Carlos Peschiera Carrillo - EsSalud ( Site 2855) | Jesús María | Lima |
| Peru | Clínica El Golf-Cardiologia ( Site 2857) | Lima | |
| Peru | Clínica Javier Prado ( Site 2853) | Lima | |
| Peru | Clínica Providencia ( Site 2856) | Lima | |
| Peru | Clínica Vesalio-Cardiology ( Site 2854) | Lima | |
| Peru | Hospital Cayetano Heredia-Servicio de cardiologia ( Site 2852) | Lima | |
| Peru | Clínica Belén ( Site 2858) | Piura | |
| Peru | Centro de investigacion Clínica Trujillo-Medical specialties ( Site 2860) | Trujillo | La Libertad |
| Poland | NZOZ Centrum Medyczne KERmed ( Site 3066) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Polsko-Amerykanskie Kliniki Serca PAKS Malopolskie Centrum Sercowo-Naczyniowe ( Site 3062) | Chrzanow | Malopolskie |
| Poland | Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii Lek. med. Krzysztof Cymerman | Gdynia | Pomorskie |
| Poland | Polsko-Amerykanskie Kliniki Serca ( Site 3077) | Kedzierzyn-Kozle | Opolskie |
| Poland | Centrum Medyczne Zdrowa J. Trebacz, W. Zajdel Sp. J. ( Site 3061) | Krakow | Malopolskie |
| Poland | Beata Miklaszewicz & Dariusz Dabrowski CARDIAMED s.j. ( Site 3070) | Legnica | Dolnoslaskie |
| Poland | NZOZ Twoja Przychodnia ( Site 3051) | Lublin | Lubelskie |
| Poland | SP ZOZ w Pulawach- Oddzial Kardiologii ( Site 3071) | Pulawy | Lubelskie |
| Poland | Centrum Medyczne Medyk ( Site 3065) | Rzeszow | Podkarpackie |
| Poland | Centrum Medyczne Dr Sudnik s.c. Wanda i Jerzy Sudnik ( Site 3073) | Sokolka | Podlaskie |
| Poland | Private Practice - Dr. Robert Witek-Osrodek Badan Klinicznych "METABOLICA" Lek. Robert Witek ( Site | Tarnów | Malopolskie |
| Poland | Praktyka Lekarska Lidia Pawlowicz ( Site 3053) | Torun | Kujawsko-pomorskie |
| Poland | Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu-Oddz.Klin.Kardiologii i Int.T.Kard. ( Si | Torun | Kujawsko-pomorskie |
| Poland | ETG Warszawa ( Site 3052) | Warszawa | Mazowieckie |
| Poland | Instytut Chorób Serca, Zaklad Badan Klinicznych Chorób Ukladu Krazenia ( Site 3057) | Wrocaw | Dolnoslaskie |
| Puerto Rico | Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 3151) | Bayamon | |
| Puerto Rico | Private Practice - Dr. Yolanda Figueroa-Torres ( Site 3156) | Humacao | |
| Puerto Rico | Research and Cardiovascular Corp. ( Site 3152) | Ponce | |
| Puerto Rico | Caparra Internal Medicine ( Site 3155) | Rio Grande | |
| Puerto Rico | VA Caribbean Healthcare System ( Site 3157) | San Juan | |
| Russian Federation | Ivanovo Regional Healthcare Institution Cardiology Dispensary ( Site 3265) | Ivanovo | Ivanovskaya Oblast |
| Russian Federation | Interregional Clinical Diagnostic Center-Department of Clinical Trials ( Site 3307) | Kazan | Tatarstan, Respublika |
| Russian Federation | Krasnodar Regional Clinical Hospital Number 1 S.V. Ochapovskogo ( Site 3281) | Krasnodar | Krasnodarskiy Kray |
| Russian Federation | State budgetary Healthcare Institution of the city of Moscow "V. V. Vinogradov City Clinical Hospita | Moscow | Moskva |
| Russian Federation | Omsk Regional Clinical Health Service Number 9 ( Site 3296) | Omsk | Omskaya Oblast |
| Russian Federation | Perm Regional Hospital for War Veterans ( Site 3272) | Perm | Permskiy Kray |
| Russian Federation | Rostov State Medical University ( Site 3259) | Rostov-on-Don | Rostovskaya Oblast |
| Russian Federation | Rostov-on-Don City Emergency Hospital ( Site 3271) | Rostov-on-Don | Rostovskaya Oblast |
| Russian Federation | Ryazan State Medical University named after Academician I.P. Pavlova ( Site 3260) | Ryazan | Ryazanskaya Oblast |
| Russian Federation | Almazov National Medical Research Centre ( Site 3320) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | First Pavlov State Medical University of Saint Petersburg ( Site 3288) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | First Pavlov State Medical University of Saint Petersburg-?ardiology department ( Site 3257) | Saint Petersburg | Leningradskaya Oblast |
| Russian Federation | Pokrovskaya Municipal Hospital ( Site 3252) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Pokrovskaya Municipal Hospital-1-st cardiology department ( Site 3251) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Astarta Clinic ( Site 3276) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | Institute for Medical Research ( Site 3316) | Sankt-Peterburg | |
| Russian Federation | Clinical Hospital S.R.Mirotvortseva name SSMU ( Site 3254) | Saratov | Saratovskaya Oblast |
| Russian Federation | City Hospital No. 4 ( Site 3269) | Sochi | Krasnodarskiy Kray |
| Russian Federation | Volgograd State Medical University ( Site 3258) | Volgograd | Volgogradskaya Oblast |
| Singapore | Changi General Hospital ( Site 3356) | Singapore | South East |
| Singapore | National Heart Centre Singapore ( Site 3351) | Singapore | Central Singapore |
| Singapore | National University Heart Centre, Singapore-Department of Cardiology ( Site 3355) | Singapore | South West |
| Singapore | Tan Tock Seng Hospital ( Site 3353) | Singapore | Central Singapore |
| South Africa | Tiervlei Trial Centre ( Site 3461) | Bellville, Cape Town | Western Cape |
| South Africa | Universitas Private Hospital-Cardiology Research ( Site 3453) | Bloemfontein | Free State |
| South Africa | Professor Ntsekhe Cardiology Clinic ( Site 3454) | Cape Town | Western Cape |
| South Africa | TREAD Research ( Site 3451) | Cape Town | Western Cape |
| South Africa | Enhancing Care Foundation ( Site 3456) | Durban | Kwazulu-Natal |
| South Africa | Excellentis Clinical Trial Consultants ( Site 3464) | George | Western Cape |
| South Africa | Lenasia Clinical Trial Centre - Johannesburg ( Site 3470) | Johannesburg | Gauteng |
| South Africa | Netcare Sunninghill Hospital ( Site 3457) | Johannesburg | Gauteng |
| South Africa | Midrand Medical Centre ( Site 3466) | Midrand | Gauteng |
| South Africa | Paarl Research Centre ( Site 3468) | Paarl | Western Cape |
| South Africa | Clinical Trial Systems ( Site 3452) | Pretoria | Gauteng |
| South Africa | University of Pretoria - Faculty of Health Sciences-CRU ( Site 3462) | Pretoria | Gauteng |
| South Africa | Jongaie Research ( Site 3469) | Pretoria West | Gauteng |
| South Africa | Chris Hani Baragwanath Academic Hospital ( Site 3455) | Soweto | Gauteng |
| Spain | CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 3666) | A Coruña | La Coruna |
| Spain | Hospital Germans Trias i Pujol ( Site 3664) | Badalona | Barcelona |
| Spain | Hospital Quiron Barcelona ( Site 3655) | Barcelona | Cataluna |
| Spain | Hospital Universitari Vall d'Hebron ( Site 3659) | Barcelona | |
| Spain | Parc de Salut Mar - Hospital del Mar ( Site 3663) | Barcelona | |
| Spain | Hospital Universitari de Bellvitge-Unitat Multidisciplinar d'Insuficiència Cardíaca Comunitària (UM | L'Hospitalet de Llobregat | Cataluna |
| Spain | Hospital Clinico San Carlos-Cardiology ( Site 3661) | Madrid | |
| Spain | Hospital Universitario La Paz ( Site 3665) | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal ( Site 3662) | Madrid | Madrid, Comunidad De |
| Spain | CHUS - Hospital Clinico Universitario-Cardiology - Clinical Research Unit ( Site 3651) | Santiago de Compostela | La Coruna |
| Spain | Hospital Universitario Virgen de Valme ( Site 3654) | Sevilla | |
| Spain | HOSPITAL CLINICO DE VALENCIA ( Site 3656) | Valencia | Valenciana, Comunitat |
| Sweden | Falu Lasarett-Dep of Cardiology ( Site 3756) | Falun | Dalarnas Lan |
| Sweden | Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 3753) | Gothenburg | Vastra Gotalands Lan |
| Sweden | Clemenstorgets Hjartmottagning ( Site 3755) | Lund | Skane Lan |
| Sweden | Universitetssjukhuset Örebro-Heart-Lung-Physiology Clinic ( Site 3754) | Örebro | Orebro Lan |
| Sweden | Skellefteå Lasarett-Research unit, floor 5 ( Site 3760) | Skellefteå | Vasterbottens Lan |
| Sweden | Karolinska Universitetssjukhuset Solna-Heart and Vascular theme ( Site 3759) | Solna | Stockholms Lan |
| Sweden | Akardo Med Site ( Site 3763) | Stockholm | Stockholms Lan |
| Sweden | Aleris Specialistvård Sabbatsberg ( Site 3762) | Stockholm | Stockholms Lan |
| Sweden | Västmanlands Sjukhus Västerås ( Site 3757) | Västerås | Vastmanlands Lan |
| Taiwan | Changhua Christian Hospital ( Site 3857) | Changhua County | Changhua |
| Taiwan | Mackay Memorial Hospital-Hsinchu ( Site 3852) | Hsinchu City | Hsinchu |
| Taiwan | Kaohsiung Medical University Hospital ( Site 3856) | Kaohsiung | |
| Taiwan | Taichung Veterans General Hospital ( Site 3855) | Taichung | |
| Taiwan | Taipei Veterans General Hospital-General Clinical Research Center ( Site 3851) | Taipei | |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 3854) | Taoyuan | |
| Turkey | Afyon Kocatepe Üniversitesi Tip Fakültesi-Cardiology Department ( Site 4058) | Afyonkarahisar | |
| Turkey | Ankara Bilkent Sehir Hastanesi-cardiology ( Site 4053) | Ankara | |
| Turkey | Hacettepe Universitesi ( Site 4061) | Ankara | |
| Turkey | Antalya Egitim ve Arastirma Hastanesi-Cardiology ( Site 4064) | Antalya | |
| Turkey | Ege University Medicine of Faculty-Cardilogy Department ( Site 4054) | Bornova | Izmir |
| Turkey | Eskisehir Osmangazi University-Cardiology ( Site 4052) | Eskisehir | |
| Turkey | Baskent Üniversitesi Istanbul Hastanesi ( Site 4057) | Istanbul | |
| Turkey | Dr. Siyami Ersek Gögüs Kalp Ve Damar Cerrahisi Egitim Ve Arastirma Hastanesi ( Site 4063) | Istanbul | |
| Turkey | Istanbul University Cerrahpasa Medical School Internal Diseases Institute-CARDIOLOGY INSTITUTE ( Sit | Istanbul | |
| Turkey | Dokuz Eylül Üniversitesi-CARDIOLOGY ( Site 4055) | Izmir | |
| Turkey | Medical Park zmir Hastanesi-cardiology ( Site 4059) | Izmir | |
| Turkey | Kocaeli Üniversitesi-Cardiology ( Site 4060) | Kocaeli | |
| Turkey | Mersin University ( Site 4056) | Mersin | |
| Ukraine | Clinical medical and diagnostic center Limited Liability Company "Simedgroup" ( Site 4284) | ?????-?????????? | Ivano-Frankivska Oblast |
| Ukraine | Cherkasy Regional Hospital-Cardiorheumatology ( Site 4283) | Cherkasy | Cherkaska Oblast |
| Ukraine | Communal non-profit enterprise "Cherkasy Regional Hospital of ?herkasy Regional Council" ( Site 4292 | Cherkasy | Cherkaska Oblast |
| Ukraine | Municipal Non-commercial Enterprise "Ivano-Frankivsk Regional Clinical Cardiology Center of Ivano-Fr | Ivano-Frankivsk | Ivano-Frankivska Oblast |
| Ukraine | Central clinical hospital - Ukrzalisnytsia-2nd Cardiology ( Site 4306) | Kharkiv | Kharkivska Oblast |
| Ukraine | Communal non-profit enterprise "City Clinical Hospital # 27" of Kharkiv City Council ( Site 4262) | Kharkiv | Kharkivska Oblast |
| Ukraine | L.T. Mala National Institute of Therapy of NAMS of Ukraine-Clinical Pharmacology and Pharmacogeneti | Kharkiv | Kharkivska Oblast |
| Ukraine | Municipal Non-Profit Enterprise -City clinical hospital No8 of Kharkiv city council ( Site 4278) | Kharkiv | Kharkivska Oblast |
| Ukraine | Khmelnytskyi Regional Cardiovascular Center-department of invasive cardiology and interventional ra | Khmelnytskyi | Khmelnytska Oblast |
| Ukraine | Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain | Kiev | Kyiv |
| Ukraine | Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 4257) | Kiev | Kyiv |
| Ukraine | Consultative - Diagnostic Centre of Pechersky District-Therapeutic department ( Site 4307) | Kyiv | |
| Ukraine | Medbud Clinic ( Site 4265) | Kyiv | Kyivska Oblast |
| Ukraine | MNE " Kyiv City Clinical Emergency Hospital" of Kyiv Regional Council (KCSA) ( Site 4256) | Kyiv | |
| Ukraine | State Institution National Scientific Center M.D. Strazhesko-Department of clinical arrhythmology a | Kyiv | |
| Ukraine | State Institution National Scientific Center M.D. Strazhesko-Essential Hypertension ( Site 4259) | Kyiv | Kyivska Oblast |
| Ukraine | State Institution National Scientific Center M.D. Strazhesko-Resuscitation and Intensive care ( Site | Kyiv | |
| Ukraine | Lutsk City Clinical Hospital-Center for Cardiovascular Disease ( Site 4255) | Lutsk | Volynska Oblast |
| Ukraine | Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 42 | Odesa | Odeska Oblast |
| Ukraine | Zakarpattya Regional Clinical Cardiology Dispensary-Dept. of Hospital Therapy, Uzhhorod National Un | Uzhgorod | Zakarpatska Oblast |
| Ukraine | Ukrayins'kyy Derzhavnyy Naukovo-Doslidnyy Instytut Rebilitatsiyi Invalidiv ( Site 4274) | Vinnytsia | Vinnytska Oblast |
| Ukraine | Communal Non-profit Enterprise "City Hospital #6" Zaporizhzhia City Counci-Therapy department ( Site | Zaporizhia | Zaporizka Oblast |
| Ukraine | Communal nonprofit enterprise "City Hospital #9" of Zaporizhzhia City Council ( Site 4251) | Zaporizhia | Zaporizka Oblast |
| Ukraine | Communal Enterprise "Hospital #1" of Zhytomyr City Council-Advisory and Treatment department of Sci | Zhytomyr | Zhytomyrska Oblast |
| United Kingdom | Craigavon Area Hospital ( Site 4162) | Belfast | Northern Ireland |
| United Kingdom | Ulster Hospital ( Site 4185) | Belfast | Lisburn And Castlereagh |
| United Kingdom | Blackpool Victoria Hospital ( Site 4161) | Blackpool | |
| United Kingdom | Layton Medical Centre ( Site 4184) | Blackpool | Lancashire |
| United Kingdom | Princess of Wales Hospital ( Site 4178) | Bridgend | Wales |
| United Kingdom | Chesterfield Royal Hospital ( Site 4159) | Calow Chesterfield | Derbyshire |
| United Kingdom | Cumberland Infirmary ( Site 4174) | Carlisle | Cumbria |
| United Kingdom | University Hospital Coventry & Warwickshire-Research & Development ( Site 4170) | Coventry | |
| United Kingdom | Carmel Medical Practice ( Site 4152) | Darlington | England |
| United Kingdom | Russells Hall Hospital ( Site 4153) | Dudley | England |
| United Kingdom | Ninewells Hospital and Medical School-Cardiology ( Site 4164) | Dundee | Dundee City |
| United Kingdom | King's College Hospital-Cardiac Research Department ( Site 4154) | London | England |
| United Kingdom | St. George's Hospital-Cardiology Clinical Academic Group ( Site 4156) | London | England |
| United Kingdom | William Harvey Heart Centre ( Site 4169) | London | London, City Of |
| United Kingdom | Prince Charles Hospital ( Site 4171) | Merthyr Tydfil | Great Britain |
| United Kingdom | The Adam Practice ( Site 4180) | Poole | |
| United Kingdom | University Hospital of North Tees ( Site 4172) | Stockton-On-Tees | |
| United Kingdom | Walsall Manor Hospital ( Site 4179) | West Midlands | Walsall |
| United Kingdom | West Cumberland Hospital ( Site 4176) | Whitehaven | Cumbria |
| United Kingdom | Worcestershire Royal Hospital-Cardiology Research Department ( Site 4181) | Worcester | Worcestershire |
| United States | Advanced Cardiovascular - Alexander City ( Site 0038) | Alexander City | Alabama |
| United States | Cambridge Medical Trials ( Site 0041) | Alexandria | Louisiana |
| United States | Emory University School of Medicine ( Site 0123) | Atlanta | Georgia |
| United States | Maryland Cardiovascular Specialists ( Site 0056) | Baltimore | Maryland |
| United States | University of Alabama at Birmingham - School of Medicine-Cardiology ( Site 0153) | Birmingham | Alabama |
| United States | Excel Medical Clinical Trials ( Site 0008) | Boca Raton | Florida |
| United States | CHEAR Center LLC ( Site 0009) | Bronx | New York |
| United States | Erie County Medical Center ( Site 0160) | Buffalo | New York |
| United States | Aultman Hospital-Cardiology Clinical Trials ( Site 0064) | Canton | Ohio |
| United States | Accellacare - Charleston ( Site 0141) | Charleston | South Carolina |
| United States | Mount Sinai Hospital ( Site 0050) | Chicago | Illinois |
| United States | University of Cincinnati Medical Center-Cardiology ( Site 0071) | Cincinnati | Ohio |
| United States | University of Missouri Hospital ( Site 0163) | Columbia | Missouri |
| United States | IACT Health ( Site 0106) | Columbus | Georgia |
| United States | New York Presbyterian Medical Group Hudson Valley Cardiology ( Site 0127) | Cortlandt Manor | New York |
| United States | Valley Clinical Trials, Inc. ( Site 0085) | Covina | California |
| United States | Dallas VA Medical Center ( Site 0084) | Dallas | Texas |
| United States | Southwest Family Medicine Associates ( Site 0131) | Dallas | Texas |
| United States | Universal Axon Clinical Research, LLC ( Site 0022) | Doral | Florida |
| United States | Doylestown Hospital-Cardiology ( Site 0030) | Doylestown | Pennsylvania |
| United States | Medresearch Inc ( Site 0043) | El Paso | Texas |
| United States | INOVA Fairfax Medical Campus ( Site 0136) | Falls Church | Virginia |
| United States | Holy Cross Hospital ( Site 0100) | Fort Lauderdale | Florida |
| United States | Mercy Gilbert Medical Center-Dignity Health Cardiology ( Site 0075) | Gilbert | Arizona |
| United States | Louisiana Heart Center - Hammond ( Site 0004) | Hammond | Louisiana |
| United States | The Heart Clinic - Hammond ( Site 0155) | Hammond | Louisiana |
| United States | Chicago Medical Research ( Site 0086) | Hazel Crest | Illinois |
| United States | Indago Research and Health Center Inc ( Site 0011) | Hialeah | Florida |
| United States | South Florida Research Solutions ( Site 0058) | Hollywood | Florida |
| United States | Cardiovascular Institute of the South ( Site 0072) | Houma | Louisiana |
| United States | West Houston Area Clinical Trial Consultants ( Site 0014) | Houston | Texas |
| United States | Heart Center Research, LLC ( Site 0156) | Huntsville | Alabama |
| United States | Franciscan Physician Network - Indiana Heart Physicians ( Site 0087) | Indianapolis | Indiana |
| United States | University of Iowa ( Site 0005) | Iowa City | Iowa |
| United States | Apex Research Foundation ( Site 0001) | Jackson | Tennessee |
| United States | Phillips Medical Services ( Site 0070) | Jackson | Mississippi |
| United States | The University of Mississippi Medical Center-Cardiovascular ( Site 0073) | Jackson | Mississippi |
| United States | East Coast Institute for Research, LLC ( Site 0047) | Jacksonville | Florida |
| United States | University of Florida - Jacksonville ( Site 0169) | Jacksonville | Florida |
| United States | NSC Research ( Site 0068) | Johns Creek | Georgia |
| United States | Logan Health Research ( Site 0017) | Kalispell | Montana |
| United States | South Texas Cardiovascular Consultants, PLLC-Research ( Site 0024) | Kerrville | Texas |
| United States | Cardiovascular Institute of the South, 3 ( Site 0096) | Lafayette | Louisiana |
| United States | Capitol Cardiology Associates - Lanham Office-Maryland Research Centers ( Site 0167) | Lanham | Maryland |
| United States | VA West Los Angeles Medical Center-Cardiology ( Site 0149) | Los Angeles | California |
| United States | Norton Healthcare-Norton Heart Specialist ( Site 0062) | Louisville | Kentucky |
| United States | Southeastern Cardiology and Cardiovascular-Duke HC CRU - Lumberton ( Site 0134) | Lumberton | North Carolina |
| United States | Georgia Arrhythmia Consultants and Research Institute ( Site 0042) | Macon | Georgia |
| United States | Carient Heart & Vascular - Manassas ( Site 0059) | Manassas | Virginia |
| United States | The Heart Center of Lake County Research Institute-Research ( Site 0147) | Merrillville | Indiana |
| United States | Cardiovascular Research Center of South Florida ( Site 0074) | Miami | Florida |
| United States | ProLive Medical Research ( Site 0032) | Miami | Florida |
| United States | IMA Clinical Research ( Site 0112) | Monroe | Louisiana |
| United States | Cardiovascular Research of Northwest Indiana ( Site 0036) | Munster | Indiana |
| United States | Vanderbilt University Medical Center-Vanderbilt Heart and Vascular Institue ( Site 0060) | Nashville | Tennessee |
| United States | Icahn School of Medicine at Mount Sinai ( Site 0161) | New York | New York |
| United States | Sentara Norfolk General Hospital ( Site 0114) | Norfolk | Virginia |
| United States | Valley Clinical Trials Inc ( Site 0006) | Northridge | California |
| United States | Cardiovascular Institute of the South ( Site 0081) | Opelousas | Louisiana |
| United States | Methodist Medical Center of Illinois ( Site 0098) | Peoria | Illinois |
| United States | OSF Healthcare Cardiovascular Institute ( Site 0122) | Peoria | Illinois |
| United States | Peace River Cardiovascular Center ( Site 0088) | Port Charlotte | Florida |
| United States | Pulse Heart Institute - Puyallup ( Site 0119) | Puyallup | Washington |
| United States | Amici Clinical Research LLC-Research ( Site 0037) | Raritan | New Jersey |
| United States | Renown Regional Medical Center-Renown Institute for Heart and Vascular Health ( Site 0168) | Reno | Nevada |
| United States | Dominion Medical Associates, Inc. ( Site 0089) | Richmond | Virginia |
| United States | Reid Physician Associates ( Site 0054) | Richmond | Indiana |
| United States | The Valley Hospital ( Site 0035) | Ridgewood | New Jersey |
| United States | BAYCARE MEDICAL GROUP ( Site 0099) | Safety Harbor | Florida |
| United States | East Coast Institute for Research - St. Augustine ( Site 0016) | Saint Augustine | Florida |
| United States | St. Louis Heart and Vascular, P.C.-Clinical Trials Unit ( Site 0029) | Saint Louis | Missouri |
| United States | Washington University-Department of Medicine ( Site 0044) | Saint Louis | Missouri |
| United States | South Texas Cardiovascular Consultants, PLLC-Research ( Site 0020) | San Antonio | Texas |
| United States | Cardiovascular Center of Sarasota ( Site 0154) | Sarasota | Florida |
| United States | Ascension Providence Hospital ( Site 0094) | Southfield | Michigan |
| United States | MultiCare Health System-MultiCare Cardiology - Inland Northwest ( Site 0102) | Spokane | Washington |
| United States | Cardiovascular Consultants of South Georgia, LLC ( Site 0137) | Thomasville | Georgia |
| United States | ProMedica Toledo Hospital-ProMedica Heart Failure Clinic ( Site 0061) | Toledo | Ohio |
| United States | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0010) | Torrance | California |
| United States | Tyler Cardiovascular Consultants ( Site 0039) | Tyler | Texas |
| United States | Blue Coast Research Center ( Site 0053) | Vista | California |
| United States | Cardiovascular Associates of the Delaware Valley ( Site 0097) | Washington Township | New Jersey |
| United States | Alliance for Multispecialty Research, LLC ( Site 0143) | Wichita | Kansas |
| United States | Accellacare - Wilmington ( Site 0090) | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Poland, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom,
Butler J, Usman MS, Anstrom KJ, Blaustein RO, Bonaca MP, Ezekowitz JA, Freitas C, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Soluble guanylate cyclase stimulators — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization | The first event of CV death or HF hospitalization as confirmed by a clinical events committee (CEC). | From date of randomization until the date of first occurrence of a CV death or HF hospitalization, assessed up to approximately 40 months | |
| Secondary | Time to First Occurrence of CV Death | The first event of CV death as confirmed by a CEC. | From date of randomization until the date of first occurrence of a CV death, assessed up to approximately 40 months | |
| Secondary | Time to First Occurrence of HF Hospitalization | The first event of HF hospitalization as confirmed by a CEC. | From date of randomization until the date of first occurrence of a HF hospitalization, assessed up to approximately 40 months | |
| Secondary | Time to Total HF Hospitalizations (Including First and Recurrent Events) | All events of HF hospitalization as confirmed by a CEC. | Up to approximately 40 months | |
| Secondary | Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization | The first event of death due to any cause or HF hospitalization as confirmed by a CEC. | From date of randomization until the date of first occurrence of death or HF hospitalization, assessed up to approximately 40 months | |
| Secondary | Time to All-Cause Mortality | The first event of death due to any cause as confirmed by a CEC. | From date of randomization until the date of death, assessed up to approximately 40 months | |
| Secondary | Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Selected NSAEs are nonserious AEs that meet any of the following criteria: AEs that lead to study intervention dose modification or discontinuation, AEs that lead to withdrawal from the study, or coronavirus disease (COVID-19) disease-related AEs. | Up to approximately 40 months | |
| Secondary | Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event, as judged medically or scientifically, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above. | Up to approximately 40 months | |
| Secondary | Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs) | Events of clinical interest will include: 1) Potential drug-induced liver injury (DILI) events defined as: elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory value that is greater than or equal to 3X the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN, as determined by way of protocol specified laboratory testing or unscheduled laboratory testing, 2) Symptomatic hypotension 3) Anemia. | Up to approximately 40 months |
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