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Using omecamtiv mecarbil 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)

Phase 3 Interventional Cytokinetics · NCT06736574

This study is testing if a new drug called omecamtiv mecarbil can help people with severe chronic heart failure live longer and avoid serious heart problems.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1800 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorCytokinetics Industry-sponsored
Locations185 sites (Alexander City, Alabama and 184 other locations)
Trial IDNCT06736574 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of omecamtiv mecarbil, an investigational drug, in patients with chronic heart failure and severely reduced ejection fraction. Participants will be randomized to receive either the drug or a placebo, and the study aims to determine if the treatment can reduce the risk of cardiovascular death, heart failure events, or the need for heart transplantation. The study will conclude when a specified number of participants experience a heart failure event or cardiovascular death, with an interim analysis planned for efficacy and futility.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with chronic heart failure and severely reduced ejection fraction who are currently hospitalized or have had a recent heart failure event.

Not a fit: Patients with heart failure who do not meet the specific ejection fraction and NT-proBNP criteria, or those currently taking digoxin, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of severe complications associated with heart failure, improving patient outcomes.

How similar studies have performed: Previous studies have shown promise with similar approaches, but this specific drug and its application in this patient population are being evaluated in a novel context.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Alexander City, Alabama and 184 other locations

+135 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureHeart Failure With Reduced Ejection FractionCK-1827452omecamtiv mecarbil
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.