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

April 29, 2026 updated by: Cytokinetics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Cytokinetics MD
Phone Number: (650) 624-2929
Email: medicalaffairs@cytokinetics.com

Study Locations

Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G2B7
    - Recruiting
    - Mazankowski Alberta Heart Institute / University of Alberta Hospital
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y1T2
    - Recruiting
    - Kelowna General Hospital
  - Surrey, British Columbia, Canada, V3V0C6
    - Recruiting
    - SMH - Cardiology Clinical Trials Inc.
  - Vancouver, British Columbia, Canada, V6Z1Y6
    - Recruiting
    - St. Paul's Hospital
  - Victoria, British Columbia, Canada, V8R1B2
    - Recruiting
    - Victoria Heart Institute Foundation
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H2A6
    - Recruiting
    - St. Boniface Hospital
- Ontario
  - Kingston, Ontario, Canada, K7L 2V7
    - Recruiting
    - Kingston Health Sciences Centre
  - London, Ontario, Canada, N6A5A5
    - Recruiting
    - London Health Sciences Centre
  - Oakville, Ontario, Canada, L6M0L8
    - Recruiting
    - Oakville Trafalgar Memorial Hospital - Halton Healthcare
  - Toronto, Ontario, Canada, M5B1W8
    - Recruiting
    - St. Michael's Hospital
  - Toronto, Ontario, Canada, M5G2C4
    - Recruiting
    - UHN-Toronto General Hospital
  - Toronto, Ontario, Canada, M4N1J7
    - Recruiting
    - Sunnybrook Health Sciences Centre
- Quebec
  - Montreal, Quebec, Canada, H1T1C8
    - Recruiting
    - Montreal Heart Institute
  - Sherbrooke, Quebec, Canada, J1L0H8
    - Recruiting
    - Diex Recherche Sherbrooke
  - Terrebonne, Quebec, Canada, J6V 2H2
    - Recruiting
    - CISSSL - Hopital Pierre-Le Gardeur
France
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31059
    - Recruiting
    - Centre Hospitalier Universitaire de Toulouse
- Hauts-de-France
  - Valenciennes, Hauts-de-France, France, 59300
    - Recruiting
    - Polyclinique Vauban
- Ille-et-Vilaine
  - Rennes, Ille-et-Vilaine, France, 35033
    - Recruiting
    - CHU de Rennes - Hôpital Pontchaillou
- Isère
  - La Tronche, Isère, France, 38700
    - Recruiting
    - Centre Hospitalier Universitaire Grenoble Alpes - Site Nord Michallon
- Occitanie
  - Montpellier, Occitanie, France, 34295
    - Recruiting
    - CHU de Montpellier- Hôpital Arnaud de Villeneuve
- Pays de la Loire Region
  - Nantes, Pays de la Loire Region, France, 44277
    - Recruiting
    - L'Hôpital Privé du Confluent
- Var
  - Toulon, Var, France, 83100
    - Recruiting
    - Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer (C.H.I.T.S)
- Île-de-France Region
  - Paris, Île-de-France Region, France, 75010
    - Recruiting
    - Hôpital Lariboisière - APHP
  - Paris, Île-de-France Region, France, 75015
    - Recruiting
    - Hôpital Europeen Georges Pompidou
  - Paris, Île-de-France Region, France, 75018
    - Recruiting
    - APHP - Hopital Bichat
Germany
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Germany, 69120
    - Recruiting
    - Heidelberg University Hospital, Clinic for Cardiology, Angiology and Pneum
- Bavaria
  - München, Bavaria, Germany, 81377
    - Recruiting
    - LMU Klinikum - Medizinische Klinik und Poliklinik I
  - Würzburg, Bavaria, Germany, 97078
    - Recruiting
    - Universitätsklinik Würzburg Deutsches Zentrum für Herzinsuffizienz
- Free and Hanseatic City of Hamburg
  - Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
    - Recruiting
    - UKE, Klinik für Kardiologie
- Germany
  - Erfurt, Germany, Germany, 99089
    - Recruiting
    - Helios Klinikum Erfurt GmbH
  - Jena, Germany, Germany, 07747
    - Recruiting
    - Universitaetsklinikum Jena
  - Mainz, Germany, Germany, 55131
    - Recruiting
    - Marienhaus Klinikum Mainz GmbH
- Hesse
  - Bad Nauheim, Hesse, Germany, 61231
    - Recruiting
    - Kerckhoff-Klinik GmbH
  - Frankfurt am Main, Hesse, Germany, 60590
    - Recruiting
    - Universitaetsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie
  - Langen, Hesse, Germany, 63225
    - Recruiting
    - Asklepios Klinik Langen-Seligenstadt GmbH
- Lower Saxony
  - Göttingen, Lower Saxony, Germany, 37075
    - Recruiting
    - Universitaetsmedizin Goettingen
- North Rhine-Westphalia
  - Bonn, North Rhine-Westphalia, Germany, 53127
    - Recruiting
    - Universitätsklinikum Bonn
- Saxony
  - Markkleeberg, Saxony, Germany, 04416
    - Recruiting
    - Dr. med. Jens Taggeselle
Greece
- Attica
  - Athens, Attica, Greece, 11527
    - Recruiting
    - General Hospital of Athens ''G. Gennimatas''
  - Athens, Attica, Greece, 11527
    - Recruiting
    - General Hospital of Athens ''Hippokratio''
  - Athens, Attica, Greece, 14233
    - Recruiting
    - General Hospital of Nea Ionia ''Konstantopouleio-Patision''
  - Chaïdári, Attica, Greece, 12462
    - Recruiting
    - University General Hospital ''ATTIKON'' - General Hospital of West Attica H
  - Voula, Attica, Greece, 16673
    - Recruiting
    - General Hospital ''Asklepieio Voulas''
- Euboea
  - Chalcis, Euboea, Greece, 34100
    - Recruiting
    - General Hospital of Chalkida
- Evros
  - Alexandroupoli, Evros, Greece, 68100
    - Recruiting
    - University General Hospital of Alexandroupolis
- Larissa
  - Larissa, Larissa, Greece, 41110
    - Recruiting
    - University General Hospital of Larissa
- Thessaloniki
  - Efkarpia, Thessaloniki, Greece, 56403
    - Recruiting
    - Papageorgiou General Hospital of Thessaloniki
  - Thessaloniki, Thessaloniki, Greece, 54636
    - Recruiting
    - AHEPA University General Hospital of Thessaloniki
Italy
- - Cona, Italy, 44124
    - Recruiting
    - Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna
  - Roma, Italy, 00163
    - Recruiting
    - IRCCS San Raffaele
- BS
  - Brescia, BS, Italy, 25123
    - Recruiting
    - ASST Spedali Civili Di Brescia
- Emilia-Romagna
  - Rimini, Emilia-Romagna, Italy, 47923
    - Recruiting
    - Ospedale Infermi
- Lombardy
  - Arzignano, Lombardy, Italy, 36071
    - Recruiting
    - Ospedale di Arzignano
  - Bergamo, Lombardy, Italy, 24127
    - Recruiting
    - Asst Papa Giovanni Xxiii
  - Milan, Lombardy, Italy, 20138
    - Recruiting
    - Centro Cardiologico Monzino
  - Sesto San Giovanni, Lombardy, Italy, 20099
    - Recruiting
    - IRCCS MultiMedica
- MI
  - Milan, MI, Italy, 20132
    - Recruiting
    - IRCCS Ospedale San Raffaele
- Province of Perugia
  - Perugia, Province of Perugia, Italy, 06129
    - Recruiting
    - A.O. Perugia - Ospedale S.Maria della Misericordia
Poland
- - Bialystok, Poland, 15276
    - Recruiting
    - Uniwersytecki Szpital Kliniczny W Bialymstoku
  - Krakow, Poland, 31202
    - Recruiting
    - Krakowski Szpital Specjalistyczny im. Sw. Jana Pawla II
  - Lodz, Poland, 90549
    - Recruiting
    - SPZOZ Uniwersytecki Szpital Kliniczny nr 2 UM w Lodzi
  - Lodz, Poland, 92213
    - Recruiting
    - SPZOZ Centralny Szpital Kliniczny UM w Lodzi
  - Miechów, Poland, 32200
    - Recruiting
    - Szpital Sw. Anny w Miechowie
  - Opole, Poland, 45401
    - Recruiting
    - Uniwersytecki Szpital Kliniczny w Opolu
  - Poznan, Poland, 61848
    - Recruiting
    - Uniwersytecki Szpital Kliniczny w Poznaniu
  - Ruda Śląska, Poland, 41710
    - Recruiting
    - Poradnia AKA-MED Centrum Sp. z o.o.
  - Torun, Poland, 87100
    - Recruiting
    - Wojewodzki Szpital Zespolony im. L. Rydygiera
  - Świdnik, Poland, 21040
    - Recruiting
    - Tomasz Blicharski Lubelskie Centrum Diagnostyczne
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 01249
    - Recruiting
    - Balsammedica Sp. z o.o.
  - Warsaw, Masovian Voivodeship, Poland, 02-097
    - Recruiting
    - Centralny Szpital Kliniczny Uck Wum
Spain
- A Coruña
  - A Coruña, A Coruña, Spain, 15006
    - Recruiting
    - Hospital Universitario A Coruña
  - Santiago de Compostela, A Coruña, Spain, 15706
    - Recruiting
    - Hospital Clínico Universitario de Santiago
- Barcelona
  - Barcelona, Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Barcelona, Spain, 08025
    - Recruiting
    - Hospital De La Santa Creu I Sant Pau
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    - Recruiting
    - Hospital Universitari de Bellvitge
- Jaen
  - Úbeda, Jaen, Spain, 23400
    - Recruiting
    - Hospital San Juan de la Cruz
- Lugo
  - Lugo, Lugo, Spain, 27003
    - Recruiting
    - Hospital Universitario Lucus Augusti
- Madrid
  - Madrid, Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre
  - Madrid, Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
  - Majadahonda, Madrid, Spain, 28222
    - Recruiting
    - Hospital Universitario Puerta de Hierro
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Recruiting
    - Hospital Universitario Virgen de la Arrixaca
- Pontevedra
  - Vigo, Pontevedra, Spain, 36312
    - Recruiting
    - CHUVI - H.U. Alvaro Cunqueiro
- Salamanca
  - Salamanca, Salamanca, Spain, 37007
    - Recruiting
    - Hospital Universitario de Salamanca
- Sevilla
  - Seville, Sevilla, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocio
- Tarragona
  - Tarragona, Tarragona, Spain, 43005
    - Recruiting
    - Hospital Universitari Joan Xxiii de Tarragona
- Valencia
  - Valencia, Valencia, Spain, 46010
    - Recruiting
    - Hospital Clinico Universitario de Valencia
  - Valencia, Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitari i Politecnic La Fe de Valencia
United Kingdom
- - Basingstoke, United Kingdom, RG249NA
    - Recruiting
    - Basingstoke and North Hampshire Hospital
  - Cottingham, United Kingdom, HU165JQ
    - Recruiting
    - Castle Hill Hospital
  - Dudley, United Kingdom, DY12HQ
    - Recruiting
    - Russells Hall Hospital
  - Dundonald, United Kingdom, BT161RH
    - Recruiting
    - Ulster Hospital
  - Glasgow, United Kingdom, G40SF
    - Recruiting
    - Glasgow Royal Infirmary
  - Swindon, United Kingdom, SN36BB
    - Recruiting
    - Great Western Hospitals
- Greater London
  - Harefield, Greater London, United Kingdom, UB96JH
    - Recruiting
    - Harefield Hospital
- Hampshire
  - Southampton, Hampshire, United Kingdom, SO166YD
    - Recruiting
    - Southampton General Hospital
- Scotland
  - Glasgow, Scotland, United Kingdom, G514TF
    - Recruiting
    - Queen Elizabeth University Hospital
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Recruiting
    - Advanced Cardiovascular, LLC
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - University of Alabama at Birmingham
- Arizona
  - Tucson, Arizona, United States, 85741
    - Withdrawn
    - Pima Heart and Vascular Clinical Research
- California
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - National Heart Institute
  - La Jolla, California, United States, 92037
    - Recruiting
    - UC San Diego Health - Sulpizio Cardiovascular Center
  - Loma Linda, California, United States, 92350
    - Recruiting
    - Nutrition Research Center (SPH)
  - Los Angeles, California, United States, 90033
    - Recruiting
    - Keck Medical Center of USC (outpatient clinic)
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA Medical Center Cardiovascular Clinic
  - Orange, California, United States, 92868
    - Recruiting
    - University of California, Irvine Medical Center
  - Sacramento, California, United States, 95817
    - Recruiting
    - UC Davis Health
  - Sacramento, California, United States, 95816
    - Recruiting
    - Sutter Institute for Medical Research (SIMR)
  - San Diego, California, United States, 92123
    - Recruiting
    - San Diego Cardiac Center
  - San Francisco, California, United States, 94109
    - Recruiting
    - California Pacific Medical Center Van Ness Campus
  - Santa Clara, California, United States, 95051
    - Recruiting
    - Kaiser Permanente Santa Clara
  - Stanford, California, United States, 94303
    - Recruiting
    - Stanford University Hospital / Stanford Health Care
  - Torrance, California, United States, 90502
    - Recruiting
    - Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - Rocky Mountain Regional VA Medical Center
- Connecticut
  - Bridgeport, Connecticut, United States, 06606
    - Recruiting
    - Cardiology Associates of Fairfield County, P.C
  - Hartford, Connecticut, United States, 06102
    - Recruiting
    - Hartford Hospital
  - New Haven, Connecticut, United States, 06519
    - Recruiting
    - Yale New Haven Health Heart & Vascular Center Outpatient Services
- Florida
  - Clearwater, Florida, United States, 33756
    - Recruiting
    - CHF Heart Clinical (Subject Visits & IP Shipments)
  - Fort Lauderdale, Florida, United States, 33308
    - Recruiting
    - Holy Cross Medical Group - Cardiology Associates
  - Hollywood, Florida, United States, 33351
    - Recruiting
    - South Florida Research Solutions, LLC
  - Jacksonville, Florida, United States, 32209
    - Recruiting
    - UF Health Jacksonville
  - Miami Beach, Florida, United States, 33140
    - Recruiting
    - Broward Research Center
  - Ocala, Florida, United States, 34471
    - Recruiting
    - Ocala Cardiovascular Research
  - Orlando, Florida, United States, 32803
    - Recruiting
    - AdventHealth
  - Tampa, Florida, United States, 33606
    - Recruiting
    - USF Health South Tampa Center for Advanced Healthcare
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Recruiting
    - Grady Health System
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory Clinic
  - Atlanta, Georgia, United States, 30309
    - Recruiting
    - Piedmont Atlanta Hospital
  - Fayetteville, Georgia, United States, 30214
    - Recruiting
    - Piedmont Fayette Hospital
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Recruiting
    - The Queen's Medical Center - Punchbowl
- Illinois
  - Naperville, Illinois, United States, 60540
    - Recruiting
    - Midwest Cardiovascular Institute
- Indiana
  - Munster, Indiana, United States, 46321
    - Recruiting
    - Cardiovascular Research of Northwest Indiana, LLC.
  - Newburgh, Indiana, United States, 47630
    - Recruiting
    - Deaconess Heart Group
  - Richmond, Indiana, United States, 47374
    - Recruiting
    - Reid Physician Associates
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - The University of Kansas Medical Center
  - Overland Park, Kansas, United States, 66211
    - Recruiting
    - AHMG Cardiology and Surgery
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - University Medical Center New Orleans
- Maine
  - Bangor, Maine, United States, 04401
    - Recruiting
    - Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - University of Maryland Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Hospital
- Missouri
  - Independence, Missouri, United States, 64057
    - Recruiting
    - Midwest Heart and Vascular Specialists, LLC
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - Saint Luke's Hospital of Kansas City
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University Center for Advanced Medicine
  - St Louis, Missouri, United States, 63136
    - Withdrawn
    - St. Louis Heart and Vascular
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - Recruiting
    - University of Nebraska Medical Center
- New Jersey
  - Bridgewater, New Jersey, United States, 08807
    - Recruiting
    - Advanced Heart Care, LLC
  - Eatontown, New Jersey, United States, 07724
    - Recruiting
    - Monmouth Cardiology Associates, LLC
- New York
  - Albany, New York, United States, 12205
    - Recruiting
    - Capital Cardiology Associates
  - Manhasset, New York, United States, 11030
    - Recruiting
    - Northwell Health North Shore University Hospital
  - New York, New York, United States, 10029
    - Recruiting
    - Mount Sinai Hospital
  - New York, New York, United States, 10032
    - Recruiting
    - Columbia University Medical Center / New York - Presbyterian
  - The Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Medical Center (Moses Campus)
- North Carolina
  - Cary, North Carolina, United States, 27518
    - Recruiting
    - WakeMed Heart & Vascular - Cary Cardiology
  - Chapel Hill, North Carolina, United States, 27599-7064
    - Recruiting
    - Clinical and Translational Research Center - University of North Carolina at Chapel Hill
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Hospital
  - Greensboro, North Carolina, United States, 27401
    - Recruiting
    - Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Wake Forest University Health Sciences
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - The Lindner Research Center at The Christ Hospital
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hospitals Cleveland Medical Center
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic
  - Marion, Ohio, United States, 43302
    - Withdrawn
    - K&R Research LLC
  - Sandusky, Ohio, United States, 44870
    - Recruiting
    - University of Hospitals North Ohio Heart
- Oklahoma
  - Tulsa, Oklahoma, United States, 74127
    - Recruiting
    - Oklahoma State University Center for Health Sciences
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health and Science University
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Recruiting
    - Capital Area Research, LLC
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Penn State Health Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina - Gazes Research Institute
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Recruiting
    - Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Recruiting
    - Stern Cardiovascular Foundation, Inc.
  - Knoxville, Tennessee, United States, 37934
    - Recruiting
    - Tennova Healthcare-Turkey Creek Medical Center
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt University Medical Center
  - Tullahoma, Tennessee, United States, 37388
    - Recruiting
    - Tennessee Center for Clinical Trials
- Texas
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Baylor University Medical Center
  - Dallas, Texas, United States, 75390
    - Recruiting
    - The University of Texas Southwestern Medical Center
  - El Paso, Texas, United States, 79902
    - Recruiting
    - Medresearch Inc
  - Galveston, Texas, United States, 77555
    - Recruiting
    - University of Texas Medical Branch - UTMB
  - Houston, Texas, United States, 77030
    - Recruiting
    - CHI St. Luke's Health Baylor College of Medicine Medical Center
  - Plano, Texas, United States, 75093
    - Recruiting
    - Baylor Scott & White Medical Center- The Hearth Hospital
- Utah
  - Murray, Utah, United States, 84107
    - Recruiting
    - Intermountain Medical Center
  - Salt Lake City, Utah, United States, 84132
    - Recruiting
    - University of Utah Health
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Recruiting
    - Sentara Norfolk General Hospital
- Washington
  - Spokane, Washington, United States, 99204
    - Recruiting
    - Providence Advanced Heart Disease and Transplant
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Medical College of Wisconsin / Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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
- 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

Exclusion Criteria:

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
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omecamtiv Mecarbil Participants 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.	Drug: Omecamtiv Mecarbil (OM) Oral Tablet
Placebo Comparator: Placebo Participants randomized to placebo will receive placebo twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.	Drug: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first event of CV death or HF event 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	Effect of omecamtiv mecarbil compared with placebo on risk of CV death and HF event	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
Time to the first HF hospitalization 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	Effect of omecamtiv mecarbil compared with placebo on risk of HF hospitalization	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
Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF 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	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	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
Time to the first event of CV death, 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	Effect of omecamtiv mecarbil compared with placebo on risk of irreversible morbidity/mortality related to HFrEF	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
Time to CV death 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	Effect of omecamtiv mecarbil compared with placebo on risk of CV mortality	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
Time to first event of 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	Effect of omecamtiv mecarbil compared with placebo on risk of stroke	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
Time to all-cause death 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	Effect of omecamtiv mecarbil compared with placebo on risk of all-cause mortality	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytokinetics

Investigators

Study Director: Cytokinetics MD, Cytokinetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CY 1033
2024-519219-32-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Heart Failure

Clinical Trials on Placebo

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