AzTrials
AzTrials

Heart FailurePhase 3COMET-HFNCT06736574

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction

A Phase 3 study testing Omecamtiv Mecarbil (OM) in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Cytokinetics at 213 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Omecamtiv Mecarbil (OM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,800 participants
Where
213 sitesin 10 countries
Study dates
19 Dec 2024to Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients who meet all the following criteria at screening may be included in the study:
  • Are between ≥ 18 years and ≤ 85 years at the signing of informed consent
  • Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening
  • Are receiving oral loop diuretics on a regular schedule
  • Patients without AFF on screening ECG:
  • LVEF < 30% within 6 months of screening
Show all 17Show fewer
  • Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL)
  • Patients with AFF on screening ECG:
  • LVEF < 25% within 6 months of screening
  • Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL)
  • Not currently taking digoxin
  • Meet one of the following criteria for a recent HF event:
  • Are currently hospitalized with the primary reason of HF
  • Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or
  • Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic.
  • Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
  • Systolic blood pressure ≤ 140 mmHg

Who cannot join

  • Any of the following criteria will exclude potential patients from the study:
  • Have AFF on the screening ECG and are currently taking digoxin
  • Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and/or any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening
  • Are admitted to a long-term care facility or hospice
  • Have a projected survival of < 12 months due to non-cardiovascular causes based on clinical judgment
  • Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening
Show all 14Show fewer
  • Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening
  • Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure)
  • Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receiving dialysis at screening
  • Have previously had a solid organ transplant
  • Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening
  • Have received omecamtiv mecarbil in a previous clinical trial
  • Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP
  • Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease

Trial locations and contacts

213 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Cytokinetics MD contact

(650) 624-2929

medicalaffairs@cytokinetics.com

213 sites in 10 countries

United States90 sites, 83 recruiting

  • Capital Cardiology Associates

    Albany, New York, 12205

    Recruiting

  • Advanced Cardiovascular, LLC

    Alexander City, Alabama, 35010

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Recruiting

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309

    Recruiting

  • Emory Clinic

    Atlanta, Georgia, 30322

    Recruiting

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

    Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

    Recruiting

  • Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center

    Bangor, Maine, 04401

    Recruiting

  • National Heart Institute

    Beverly Hills, California, 90211

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Recruiting

  • Cardiology Associates of Fairfield County, P.C

    Bridgeport, Connecticut, 06606

    Recruiting

  • Advanced Heart Care, LLC

    Bridgewater, New Jersey, 08807

    Recruiting

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

    Recruiting

  • WakeMed Heart & Vascular - Cary Cardiology

    Cary, North Carolina, 27518

    Recruiting

  • Clinical and Translational Research Center - University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7064

    Recruiting

  • Medical University of South Carolina - Gazes Research Institute

    Charleston, South Carolina, 29425

    Recruiting

  • The Lindner Research Center at the Christ Hospital

    Cincinnati, Ohio, 45219

    Recruiting

  • CHF Heart Clinical (Subject Visits & IP Shipments)

    Clearwater, Florida, 33756

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Recruiting

  • Duke University Hospital

    Durham, North Carolina, 27710

    Recruiting

  • Monmouth Cardiology Associates, LLC

    Eatontown, New Jersey, 07724

    Recruiting

  • Medresearch Inc

    El Paso, Texas, 79902

    Withdrawn

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

    Recruiting

  • Holy Cross Medical Group - Cardiology Associates

    Fort Lauderdale, Florida, 33308

    Recruiting

  • University of Texas Medical Branch - UTMB

    Galveston, Texas, 77555

    Recruiting

  • Stern Cardiovascular Foundation, Inc.

    Germantown, Tennessee, 38138

    Recruiting

  • Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health

    Greensboro, North Carolina, 27401

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Recruiting

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Recruiting

  • South Florida Research Solutions, LLC

    Hollywood, Florida, 33351

    Recruiting

  • The Queen's Medical Center - Punchbowl

    Honolulu, Hawaii, 96813

    Recruiting

  • CHI St. Luke's Health Baylor College of Medicine Medical Center

    Houston, Texas, 77030

    Recruiting

  • Midwest Heart and Vascular Specialists, LLC

    Independence, Missouri, 64057

    Withdrawn

  • UF Health Jacksonville

    Jacksonville, Florida, 32209

    Recruiting

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Recruiting

  • Tennova Healthcare-Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

    Recruiting

  • UC San Diego Health - Sulpizio Cardiovascular Center

    La Jolla, California, 92037

    Recruiting

  • Nutrition Research Center (SPH)

    Loma Linda, California, 92350

    Recruiting

  • Keck Medical Center of USC (outpatient clinic)

    Los Angeles, California, 90033

    Recruiting

  • UCLA Medical Center Cardiovascular Clinic

    Los Angeles, California, 90095

    Recruiting

  • Northwell Health North Shore University Hospital

    Manhasset, New York, 11030

    Recruiting

  • K&R Research LLC

    Marion, Ohio, 43302

    Withdrawn

  • Broward Research Center

    Miami Beach, Florida, 33140

    Recruiting

  • Medical College of Wisconsin / Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Cardiovascular Research of Northwest Indiana, LLC.

    Munster, Indiana, 46321

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Recruiting

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Recruiting

  • Yale New Haven Health Heart & Vascular Center Outpatient Services

    New Haven, Connecticut, 06519

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Recruiting

  • Columbia University Medical Center / New York - Presbyterian

    New York, New York, 10032

    Recruiting

  • Deaconess Heart Group

    Newburgh, Indiana, 47630

    Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

    Withdrawn

  • Ocala Cardiovascular Research

    Ocala, Florida, 34471

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Recruiting

  • University of California, Irvine Medical Center

    Orange, California, 92868

    Recruiting

  • AdventHealth

    Orlando, Florida, 32803

    Recruiting

  • AHMG Cardiology and Surgery

    Overland Park, Kansas, 66211

    Recruiting

  • Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Baylor Scott & White Medical Center- The Hearth Hospital

    Plano, Texas, 75093

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Recruiting

  • Hudson Valley Cardiovascular Practice

    Poughkeepsie, New York, 12601

    Recruiting

  • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

    Rapid City, South Dakota, 57701

    Recruiting

  • Reid Physician Associates

    Richmond, Indiana, 47374

    Recruiting

  • Sutter Institute for Medical Research (SIMR)

    Sacramento, California, 95816

    Recruiting

  • UC Davis Health

    Sacramento, California, 95817

    Recruiting

  • University of Utah Health

    Salt Lake City, Utah, 84132

    Recruiting

  • San Diego Cardiac Center

    San Diego, California, 92123

    Recruiting

  • California Pacific Medical Center Van Ness Campus

    San Francisco, California, 94109

    Recruiting

  • University of Hospitals North Ohio Heart

    Sandusky, Ohio, 44870

    Withdrawn

  • Kaiser Permanente Santa Clara

    Santa Clara, California, 95051

    Recruiting

  • Providence Advanced Heart Disease and Transplant

    Spokane, Washington, 99204

    Recruiting

  • Washington University Center for Advanced Medicine

    St Louis, Missouri, 63110

    Recruiting

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

    Withdrawn

  • Stanford University Hospital / Stanford Health Care

    Stanford, California, 94303

    Recruiting

  • USF Health South Tampa Center for Advanced Healthcare

    Tampa, Florida, 33606

    Recruiting

  • Saint Josephs Hospitals

    Tampa, Florida, 33607

    Recruiting

  • Montefiore Medical Center (Moses Campus)

    The Bronx, New York, 10467

    Recruiting

  • Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

    Torrance, California, 90502

    Recruiting

  • Pima Heart and Vascular Clinical Research

    Tucson, Arizona, 85741

    Withdrawn

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388

    Recruiting

  • Oklahoma State University Center for Health Sciences

    Tulsa, Oklahoma, 74127

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

China24 sites, 24 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100032

    Recruiting

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, 130033

    Recruiting

  • People's Hospital of Hunan Province

    Changsha, Hunan, 410011

    Recruiting

  • Affiliated Hospital of Chifeng University

    Chifeng, Inner Mongolia, 024005

    Recruiting

  • Chongqing Emergency Medical Center

    Chongqing, Chongqing Municipality, 400014

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

    Recruiting

  • The Affiliated Panyu Central Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 511400

    Recruiting

  • Hainan General Hospital

    Haikou, 570311

    Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

    Recruiting

  • The First Affiliated Hospital of University of South China

    Hengyang, 421001

    Recruiting

  • Heze Municipal Hospital

    Heze, Shandong, 274002

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272029

    Recruiting

  • Lanzhou University Second

    Lanzhou, Gansu, 730030

    Recruiting

  • Zhejiang Province Taizhou Hospital

    Linhai, Taizhou, 317000

    Recruiting

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang, Henan, 471031

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530020

    Recruiting

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

    Recruiting

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300020

    Recruiting

  • Teda International Cardiovascular Hospital

    Tianjin, Tianjin Municipality, 300457

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

    Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

    Recruiting

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 44000

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

Spain17 sites, 17 recruiting

  • Hospital Universitario A Coruña

    A Coruña, A Coruña, 15006

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

    Recruiting

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120

    Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

    Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

    Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

    Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, Salamanca, 37007

    Recruiting

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla, 41013

    Recruiting

  • Hospital Universitari Joan XXIII de Tarragona

    Tarragona, Tarragona, 43005

    Recruiting

  • Hospital San Juan de la Cruz

    Úbeda, Jaen, 23400

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

    Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, Valencia, 46026

    Recruiting

  • CHUVI - H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

    Recruiting

Other trials in Spain

Canada15 sites, 14 recruiting

  • Mazankowski Alberta Heart Institute / University of Alberta Hospital

    Edmonton, Alberta, T6G2B7

    Recruiting

  • Kelowna General Hospital

    Kelowna, British Columbia, V1Y1T2

    Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Recruiting

  • London Health Sciences Centre

    London, Ontario, N6A5A5

    Recruiting

  • Montreal Heart Institute

    Montreal, Quebec, H1T1C8

    Recruiting

  • Oakville Trafalgar Memorial Hospital - Halton Healthcare

    Oakville, Ontario, L6M0L8

    Recruiting

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1L0H8

    Withdrawn

  • SMH - Cardiology Clinical Trials Inc.

    Surrey, British Columbia, V3V0C6

    Recruiting

  • CISSSL - Hopital Pierre-Le Gardeur

    Terrebonne, Quebec, J6V 2H2

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N1J7

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

    Recruiting

  • UHN-Toronto General Hospital

    Toronto, Ontario, M5G2C4

    Recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z1Y6

    Recruiting

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R1B2

    Recruiting

  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H2A6

    Recruiting

Other trials in Canada

Germany15 sites, 15 recruiting

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, Hesse, 61231

    Recruiting

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

  • Helios Klinikum Erfurt GmbH

    Erfurt, Germany, 99089

    Recruiting

  • Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie

    Frankfurt am Main, Hesse, 60590

    Recruiting

  • Universitaetsmedizin Goettingen

    Göttingen, Lower Saxony, 37075

    Recruiting

  • UKE, Klinik fur Kardiologie

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Recruiting

  • UKE, Klinik für Kardiologie

    Hamburg, Free and Hanseatic City of Hamburg, 20246

    Recruiting

  • Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum

    Heidelberg, Baden-Wurttemberg, 69120

    Recruiting

  • Uniklinikum Saarland

    Homburg, Saarland, 66424

    Recruiting

  • Universitaetsklinikum Jena

    Jena, Germany, 07747

    Recruiting

  • Asklepios Klinik Langen-Seligenstadt GmbH

    Langen, Hesse, 63225

    Recruiting

  • Marienhaus Klinikum Mainz GmbH

    Mainz, Germany, 55131

    Recruiting

  • Dr. med. Jens Taggeselle

    Markkleeberg, Saxony, 04416

    Recruiting

  • LMU Klinikum - Medizinische Klinik und Poliklinik I

    München, Bavaria, 81377

    Recruiting

  • Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz

    Würzburg, Bavaria, 97078

    Recruiting

Other trials in Germany

Poland12 sites, 12 recruiting

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15276

    Recruiting

  • Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II

    Krakow, 31202

    Recruiting

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi

    Lodz, 90549

    Recruiting

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi

    Lodz, 92213

    Recruiting

  • Szpital Sw. Anny w Miechowie

    Miechów, 32200

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Opolu

    Opole, 45401

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 61848

    Recruiting

  • Poradnia AKA-MED Centrum Sp. z o.o.

    Ruda Śląska, 41710

    Recruiting

  • Tomasz Blicharski Lubelskie Centrum Diagnostyczne

    Świdnik, 21040

    Recruiting

  • Wojewodzki Szpital Zespolony im. L. Rydygiera

    Torun, 87100

    Recruiting

  • Balsammedica Sp. z o.o.

    Warsaw, Masovian Voivodeship, 01249

    Recruiting

  • Centralny Szpital Kliniczny UCK WUM

    Warsaw, Masovian Voivodeship, 02-097

    Recruiting

Other trials in Poland

France11 sites, 11 recruiting

  • Hospices Civils de Lyon - Hôpital Louis Pradel

    Bron, Rhône, 69677

    Recruiting

  • Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon

    La Tronche, Isère, 38700

    Recruiting

  • CHU de Montpellier- Hôpital Arnaud de Villeneuve

    Montpellier, Occitanie, 34295

    Recruiting

  • L'Hôpital Privé Du Confluent

    Nantes, Pays de la Loire Region, 44277

    Recruiting

  • Hôpital Lariboisière - APHP

    Paris, Île-de-France Region, 75010

    Recruiting

  • Hôpital Européen Georges Pompidou

    Paris, Île-de-France Region, 75015

    Recruiting

  • APHP - Hôpital Bichât

    Paris, Île-de-France Region, 75018

    Recruiting

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine, 35033

    Recruiting

  • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)

    Toulon, Var, 83100

    Recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, Haute-Garonne, 31059

    Recruiting

  • Polyclinique Vauban

    Valenciennes, Hauts-de-France, 59300

    Recruiting

Other trials in France

Greece10 sites, 10 recruiting

  • University General Hospital of Alexandroupolis

    Alexandroupoli, Evros, 68100

    Recruiting

  • General Hospital of Athens ''G. Gennimatas''

    Athens, Attica, 11527

    Recruiting

  • General Hospital of Athens ''Hippokratio''

    Athens, Attica, 11527

    Recruiting

  • General Hospital of Nea Ionia ''Konstantopouleio-Patision''

    Athens, Attica, 14233

    Recruiting

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H

    Chaïdári, Attica, 12462

    Recruiting

  • General Hospital of Chalkida

    Chalcis, Euboea, 34100

    Recruiting

  • Papageorgiou General Hospital of Thessaloniki

    Efkarpia, Thessaloniki, 56403

    Recruiting

  • University General Hospital of Larissa

    Larissa, Larissa, 41110

    Recruiting

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, Thessaloniki, 54636

    Recruiting

  • General Hospital ''Asklepieio Voulas''

    Voula, Attica, 16673

    Recruiting

Other trials in Greece

Italy10 sites, 10 recruiting

  • Ospedale di Arzignano

    Arzignano, Lombardy, 36071

    Recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

    Recruiting

  • ASST Spedali Civili di Brescia

    Brescia, BS, 25123

    Recruiting

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna

    Cona, 44124

    Recruiting

  • Centro Cardiologico Monzino

    Milan, Lombardy, 20138

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132

    Recruiting

  • A.O. Perugia - Ospedale S.Maria della Misericordia

    Perugia, Province of Perugia, 06129

    Recruiting

  • Ospedale Infermi

    Rimini, Emilia-Romagna, 47923

    Recruiting

  • IRCCS San Raffaele

    Roma, 00163

    Recruiting

  • IRCCS Multimedica

    Sesto San Giovanni, Lombardy, 20099

    Recruiting

Other trials in Italy

United Kingdom9 sites, 9 recruiting

  • Basingstoke and North Hampshire Hospital

    Basingstoke, RG249NA

    Recruiting

  • Castle Hill Hospital

    Cottingham, HU165JQ

    Recruiting

  • Russells Hall Hospital

    Dudley, DY12HQ

    Recruiting

  • Ulster Hospital

    Dundonald, BT161RH

    Recruiting

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G514TF

    Recruiting

  • Glasgow Royal Infirmary

    Glasgow, G40SF

    Recruiting

  • Harefield Hospital

    Harefield, Greater London, UB96JH

    Recruiting

  • Southampton General Hospital

    Southampton, Hampshire, SO166YD

    Recruiting

  • Great Western Hospitals

    Swindon, SN36BB

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

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.

Read the 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.

Being tested
Omecamtiv Mecarbil (OM), Placebo
Keywords
CK-1827452, omecamtiv mecarbil
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omecamtiv Mecarbil (OM)Drug

    Oral Tablet

  • PlaceboDrug

    Oral Tablet

Study groups in NCT06736574
Study groupRoleWhat they receive
Omecamtiv MecarbilExperimentalParticipants randomized to omecamtiv mecarbil will be dosed based on their omecamtiv mecarbil plasma concentration at 25, 37.5 or 50 mg twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.
Receives: Drug: Omecamtiv Mecarbil (OM)
PlaceboPlacebo comparatorParticipants randomized to placebo will receive placebo twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke

    Efficacy of omecamtiv mecarbil compared with placebo on the risk of HF outcomes in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy per local standard of care.

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

Secondary outcomes (7)

  1. Time to the first event of CV death or HF event

    Effect of omecamtiv mecarbil compared with placebo on risk of CV death and HF event

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

  2. Time to the first HF hospitalization

    Effect of omecamtiv mecarbil compared with placebo on risk of HF hospitalization

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

  3. Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF

    Effect of omecamtiv mecarbil compared with placebo on risk of HF outcomes in patients with severe HF, defined as patients with NYHA class 3-4 symptoms and a HF event within the last 3 months

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

  4. Time to the first event of CV death, LVAD implantation/cardiac transplantation, or stroke

    Effect of omecamtiv mecarbil compared with placebo on risk of irreversible morbidity/mortality related to HFrEF

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

  5. Time to CV death

    Effect of omecamtiv mecarbil compared with placebo on risk of CV mortality

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

  6. Time to first event of stroke

    Effect of omecamtiv mecarbil compared with placebo on risk of stroke

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

  7. Time to all-cause death

    Effect of omecamtiv mecarbil compared with placebo on risk of all-cause mortality

    Measured: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study start19 Dec 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06736574
Sponsor's protocol ID
CY 1033
Other IDs
2024-519219-32-00
Acronym
COMET-HF
Status last verified
Jul 2026
First submitted
3 Dec 2024
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aksentijevic D, Sedej S, Fauconnier J, Paillard M, Abdellatif M, Streckfuss-Bomeke K, Ventura-Clapier R, van der Velden J, de Boer RA, Bertero E, Dudek J, Sequeira V, Maack C. Mechano-energetic uncoupling in heart failure. Nat Rev Cardiol. 2025 Oct;22(10):773-797. doi: 10.1038/s41569-025-01167-6. Epub 2025 Jun 22.

    PubMed 40544170

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omecamtiv Mecarbil (OM) in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Cytokinetics at 213 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 213 sites in United States, China, Spain, Canada, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cytokinetics MD ((650) 624-2929, medicalaffairs@cytokinetics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke (time frame: From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06736574, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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