Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Start Date
12/19/2024
Completion Date
12/1/2027
Summary
The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.
Detailed Description
This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF). Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed. Estimated duration of participation: Up to 3 years.
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
Omecamtiv Mecarbil (OM)
Placebo
Conditions
Locations
Advanced Cardiovascular, LLC
Alexander City, Alabama 35010
United States
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Pima Heart and Vascular Clinical Research
Tucson, Arizona 85741
United States
National Heart Institute
Beverly Hills, California 90211
United States
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California 92037
United States
Nutrition Research Center (SPH)
Loma Linda, California 92350
United States
Keck Medical Center of USC (outpatient clinic)
Los Angeles, California 90033
United States
UCLA Medical Center Cardiovascular Clinic
Los Angeles, California 90095
United States
University of California, Irvine Medical Center
Orange, California 92868
United States
Sutter Institute for Medical Research (SIMR)
Sacramento, California 95816
United States
UC Davis Health
Sacramento, California 95817
United States
San Diego Cardiac Center
San Diego, California 92123
United States
California Pacific Medical Center Van Ness Campus
San Francisco, California 94109
United States
Kaiser Permanente Santa Clara
Santa Clara, California 95051
United States
Stanford University Hospital / Stanford Health Care
Stanford, California 94303
United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California 90502
United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045
United States
Cardiology Associates of Fairfield County, P.C
Bridgeport, Connecticut 06606
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Yale New Haven Health Heart & Vascular Center Outpatient Services
New Haven, Connecticut 06519
United States
CHF Heart Clinical (Subject Visits & IP Shipments)
Clearwater, Florida 33756
United States
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale, Florida 33308
United States
South Florida Research Solutions, LLC
Hollywood, Florida 33351
United States
UF Health Jacksonville
Jacksonville, Florida 32209
United States
Broward Research Center
Miami Beach, Florida 33140
United States
Ocala Cardiovascular Research
Ocala, Florida 34471
United States
AdventHealth
Orlando, Florida 32803
United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida 33606
United States
Grady Health System
Atlanta, Georgia 30303
United States
Piedmont Atlanta Hospital
Atlanta, Georgia 30309
United States
Emory Clinic
Atlanta, Georgia 30322
United States
Piedmont Fayette Hospital
Fayetteville, Georgia 30214
United States
The Queen's Medical Center - Punchbowl
Honolulu, Hawaii 96813
United States
Midwest Cardiovascular Institute
Naperville, Illinois 60540
United States
Cardiovascular Research of Northwest Indiana, LLC.
Munster, Indiana 46321
United States
Deaconess Heart Group
Newburgh, Indiana 47630
United States
Reid Physician Associates
Richmond, Indiana 47374
United States
The University of Kansas Medical Center
Kansas City, Kansas 66160
United States
AHMG Cardiology and Surgery
Overland Park, Kansas 66211
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
Bangor, Maine 04401
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Midwest Heart and Vascular Specialists, LLC
Independence, Missouri 64057
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United States
Washington University Center for Advanced Medicine
St Louis, Missouri 63110
United States
St. Louis Heart and Vascular
St Louis, Missouri 63136
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Advanced Heart Care, LLC
Bridgewater, New Jersey 08807
United States
Monmouth Cardiology Associates, LLC
Eatontown, New Jersey 07724
United States
Capital Cardiology Associates
Albany, New York 12205
United States
Northwell Health North Shore University Hospital
Manhasset, New York 11030
United States
Mount Sinai Hospital
New York, New York 10029
United States
Columbia University Medical Center / New York - Presbyterian
New York, New York 10032
United States
Montefiore Medical Center (Moses Campus)
The Bronx, New York 10467
United States
WakeMed Heart & Vascular - Cary Cardiology
Cary, North Carolina 27518
United States
Clinical and Translational Research Center - University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599-7064
United States
Duke University Hospital
Durham, North Carolina 27710
United States
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina 27401
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
The Lindner Research Center at the Christ Hospital
Cincinnati, Ohio 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
K&R Research LLC
Marion, Ohio 43302
United States
University of Hospitals North Ohio Heart
Sandusky, Ohio 44870
United States
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma 74127
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Capital Area Research, LLC
Camp Hill, Pennsylvania 17011
United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
Philadelphia, Pennsylvania 19104
United States
Medical University of South Carolina - Gazes Research Institute
Charleston, South Carolina 29425
United States
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota 57701
United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee 38138
United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee 37934
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee 37388
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
The University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Medresearch Inc
El Paso, Texas 79902
United States
University of Texas Medical Branch - UTMB
Galveston, Texas 77555
United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas 77030
United States
Baylor Scott & White Medical Center- The Hearth Hospital
Plano, Texas 75093
United States
Intermountain Medical Center
Murray, Utah 84107
United States
University of Utah Health
Salt Lake City, Utah 84132
United States
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
Providence Advanced Heart Disease and Transplant
Spokane, Washington 99204
United States
Medical College of Wisconsin / Froedtert Hospital
Milwaukee, Wisconsin 53226
United States
Mazankowski Alberta Heart Institute / University of Alberta Hospital
Edmonton, Alberta T6G2B7
Canada
Kelowna General Hospital
Kelowna, British Columbia V1Y1T2
Canada
SMH - Cardiology Clinical Trials Inc.
Surrey, British Columbia V3V0C6
Canada
St. Paul's Hospital
Vancouver, British Columbia V6Z1Y6
Canada
Victoria Heart Institute Foundation
Victoria, British Columbia V8R1B2
Canada
St. Boniface Hospital
Winnipeg, Manitoba R2H2A6
Canada
Kingston Health Sciences Centre
Kingston, Ontario K7L 2V7
Canada
London Health Sciences Centre
London, Ontario N6A5A5
Canada
Oakville Trafalgar Memorial Hospital - Halton Healthcare
Oakville, Ontario L6M0L8
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N1J7
Canada
St. Michael's Hospital
Toronto, Ontario M5B1W8
Canada
UHN-Toronto General Hospital
Toronto, Ontario M5G2C4
Canada
Montreal Heart Institute
Montreal, Quebec H1T1C8
Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec J1L0H8
Canada
CISSSL - Hopital Pierre-Le Gardeur
Terrebonne, Quebec J6V 2H2
Canada
Peking University Third Hospital
Beijing, Beijing Municipality 100032
China
Lanzhou University Second
Lanzhou, Gansu 730030
China
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong 511400
China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong 518053
China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan 471031
China
People's Hospital of Hunan Province
Changsha, Hunan 410011
China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu 225001
China
Heze Municipal Hospital
Heze, Shandong 274002
China
Yuncheng Central Hospital
Yuncheng, Shanxi 44000
China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality 300020
China
Teda International Cardiovascular Hospital
Tianjin, Tianjin Municipality 300457
China
The First Affiliated Hospital of University of South China
Hengyang, 421001
China
Centre Hospitalier Universitaire de Toulouse
Toulouse, Haute-Garonne 31059
France
Polyclinique Vauban
Valenciennes, Hauts-de-France 59300
France
CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine 35033
France
Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
La Tronche, Isère 38700
France
CHU de Montpellier- Hôpital Arnaud de Villeneuve
Montpellier, Occitanie 34295
France
L'Hôpital Privé Du Confluent
Nantes, Pays de la Loire Region 44277
France
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, Rhône 69677
France
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)
Toulon, Var 83100
France
Hôpital Lariboisière - APHP
Paris, Île-de-France Region 75010
France
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region 75015
France
APHP - Hôpital Bichât
Paris, Île-de-France Region 75018
France
Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
Heidelberg, Baden-Wurttemberg 69120
Germany
LMU Klinikum - Medizinische Klinik und Poliklinik I
München, Bavaria 81377
Germany
Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz
Würzburg, Bavaria 97078
Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Hesse 61231
Germany
Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
Frankfurt am Main, Hesse 60590
Germany
Asklepios Klinik Langen-Seligenstadt GmbH
Langen, Hesse 63225
Germany
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony 37075
Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia 53127
Germany
Uniklinikum Saarland
Homburg, Saarland 66424
Germany
Dr. med. Jens Taggeselle
Markkleeberg, Saxony 04416
Germany
Helios Klinikum Erfurt GmbH
Erfurt, 99089
Germany
UKE, Klinik fur Kardiologie
Hamburg, 20246
Germany
UKE, Klinik für Kardiologie
Hamburg, 20246
Germany
Universitaetsklinikum Jena
Jena, 07747
Germany
Marienhaus Klinikum Mainz GmbH
Mainz, 55131
Germany
General Hospital of Athens ''G. Gennimatas''
Athens, Attica 11527
Greece
General Hospital of Athens ''Hippokratio''
Athens, Attica 11527
Greece
General Hospital of Nea Ionia ''Konstantopouleio-Patision''
Athens, Attica 14233
Greece
University General Hospital ''ATTIKON'' - General Hospital of West Attica H
Chaïdári, Attica 12462
Greece
General Hospital ''Asklepieio Voulas''
Voula, Attica 16673
Greece
General Hospital of Chalkida
Chalcis, Euboea 34100
Greece
University General Hospital of Alexandroupolis
Alexandroupoli, Evros 68100
Greece
Papageorgiou General Hospital of Thessaloniki
Efkarpia, Thessaloniki 56403
Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloniki 54636
Greece
University General Hospital of Larissa
Larissa, 41110
Greece
ASST Spedali Civili di Brescia
Brescia, BS 25123
Italy
Ospedale Infermi
Rimini, Emilia-Romagna 47923
Italy
Ospedale di Arzignano
Arzignano, Lombardy 36071
Italy
ASST Papa Giovanni XXIII
Bergamo, Lombardy 24127
Italy
Centro Cardiologico Monzino
Milan, Lombardy 20138
Italy
IRCCS Multimedica
Sesto San Giovanni, Lombardy 20099
Italy
IRCCS Ospedale San Raffaele
Milan, MI 20132
Italy
A.O. Perugia - Ospedale S.Maria della Misericordia
Perugia, Province Of Perugia 06129
Italy
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
Cona, 44124
Italy
IRCCS San Raffaele
Roma, 00163
Italy
Balsammedica Sp. z o.o.
Warsaw, Masovian Voivodeship 01249
Poland
Centralny Szpital Kliniczny UCK WUM
Warsaw, Masovian Voivodeship 02-097
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15276
Poland
Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
Krakow, 31202
Poland
SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
Lodz, 90549
Poland
SPZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, 92213
Poland
Szpital Sw. Anny w Miechowie
Miechów, 32200
Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45401
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 61848
Poland
Poradnia AKA-MED Centrum Sp. z o.o.
Ruda Śląska, 41710
Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Świdnik, 21040
Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera
Torun, 87100
Poland
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña 15706
Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Hospital San Juan de la Cruz
Úbeda, Jaen 23400
Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid 28222
Spain
Hospital Universitario Virgen de La Arrixaca
El Palmar, Murcia 30120
Spain
CHUVI - H.U. Alvaro Cunqueiro
Vigo, Pontevedra 36312
Spain
Hospital Universitario A Coruña
A Coruña, 15006
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Universitario Lucus Augusti
Lugo, 27003
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario de Salamanca
Salamanca, 37007
Spain
Hospital Universitario Virgen del Rocío
Seville, 41013
Spain
Hospital Universitari Joan XXIII de Tarragona
Tarragona, 43005
Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010
Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
Spain
Harefield Hospital
Harefield, Greater London UB96JH
United Kingdom
Southampton General Hospital
Southampton, Hampshire SO166YD
United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland G514TF
United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, RG249NA
United Kingdom
Castle Hill Hospital
Cottingham, HU165JQ
United Kingdom
Russells Hall Hospital
Dudley, DY12HQ
United Kingdom
Ulster Hospital
Dundonald, BT161RH
United Kingdom
Glasgow Royal Infirmary
Glasgow, G40SF
United Kingdom
Great Western Hospitals
Swindon, SN36BB
United Kingdom