NCT06736574From ClinicalTrials.govRecruiting

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

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)

Heart Failure
Heart Failure With Reduced Ejection Fraction

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Cytokinetics
Enrolment target: 1,800
Started: 19 December 2024
Main results due: September 2027
Study sites: 208
Registry updated: 24 September 2026

Can you take part?

Ages 18 years to 85 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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 sites(208)

Advanced Cardiovascular, LLC
Alexander City, Alabama, United States
Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
Pima Heart and Vascular Clinical Research
Tucson, Arizona, United States
Withdrawn
National Heart Institute
Beverly Hills, California, United States
Recruiting
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States
Recruiting
Nutrition Research Center (SPH)
Loma Linda, California, United States
Recruiting
Keck Medical Center of USC (outpatient clinic)
Los Angeles, California, United States
Recruiting
UCLA Medical Center Cardiovascular Clinic
Los Angeles, California, United States
Recruiting
University of California, Irvine Medical Center
Orange, California, United States
Recruiting
Sutter Institute for Medical Research (SIMR)
Sacramento, California, United States
Recruiting
UC Davis Health
Sacramento, California, United States
Recruiting
San Diego Cardiac Center
San Diego, California, United States
Recruiting
California Pacific Medical Center Van Ness Campus
San Francisco, California, United States
Recruiting
Kaiser Permanente Santa Clara
Santa Clara, California, United States
Recruiting
Stanford University Hospital / Stanford Health Care
Stanford, California, United States
Recruiting
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States
Recruiting
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
Recruiting
Cardiology Associates of Fairfield County, P.C
Bridgeport, Connecticut, United States
Recruiting
Hartford Hospital
Hartford, Connecticut, United States
Recruiting
Yale New Haven Health Heart & Vascular Center Outpatient Services
New Haven, Connecticut, United States
Recruiting
CHF Heart Clinical (Subject Visits & IP Shipments)
Clearwater, Florida, United States
Recruiting
Holy Cross Medical Group - Cardiology Associates
Fort Lauderdale, Florida, United States
Recruiting
South Florida Research Solutions, LLC
Hollywood, Florida, United States
Recruiting
UF Health Jacksonville
Jacksonville, Florida, United States
Recruiting
Broward Research Center
Miami Beach, Florida, United States
Recruiting
Ocala Cardiovascular Research
Ocala, Florida, United States
Recruiting
AdventHealth
Orlando, Florida, United States
Recruiting
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States
Recruiting
Grady Health System
Atlanta, Georgia, United States
Recruiting
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Recruiting
Emory Clinic
Atlanta, Georgia, United States
Recruiting
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Recruiting
The Queen's Medical Center - Punchbowl
Honolulu, Hawaii, United States
Recruiting
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Recruiting
Cardiovascular Research of Northwest Indiana, LLC.
Munster, Indiana, United States
Recruiting
Deaconess Heart Group
Newburgh, Indiana, United States
Recruiting
Reid Physician Associates
Richmond, Indiana, United States
Recruiting
The University of Kansas Medical Center
Kansas City, Kansas, United States
Recruiting
AHMG Cardiology and Surgery
Overland Park, Kansas, United States
Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, United States
Recruiting
Eastern Main Medical Center dba Northern Light Eastern Maine Medical Center
Bangor, Maine, United States
Recruiting
University of Maryland Medical Center
Baltimore, Maryland, United States
Recruiting
Tufts Medical Center
Boston, Massachusetts, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Recruiting
Midwest Heart and Vascular Specialists, LLC
Independence, Missouri, United States
Withdrawn
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Recruiting
Washington University Center for Advanced Medicine
St Louis, Missouri, United States
Recruiting
St. Louis Heart and Vascular
St Louis, Missouri, United States
Withdrawn
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
Advanced Heart Care, LLC
Bridgewater, New Jersey, United States
Recruiting
Monmouth Cardiology Associates, LLC
Eatontown, New Jersey, United States
Recruiting
Capital Cardiology Associates
Albany, New York, United States
Recruiting
Northwell Health North Shore University Hospital
Manhasset, New York, United States
Recruiting
Mount Sinai Hospital
New York, New York, United States
Recruiting
Columbia University Medical Center / New York - Presbyterian
New York, New York, United States
Recruiting
Montefiore Medical Center (Moses Campus)
The Bronx, New York, United States
Recruiting
WakeMed Heart & Vascular - Cary Cardiology
Cary, North Carolina, United States
Recruiting
Clinical and Translational Research Center - University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Recruiting
Duke University Hospital
Durham, North Carolina, United States
Recruiting
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina, United States
Recruiting

Showing 60 of 208 sites — filter to narrow it down. 200 of the 208 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06736574. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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