What is omecamtiv mecarbil studying for heart failure?

Omecamtiv mecarbil is being studied to see if it can reduce risks like hospitalization, heart transplant, or death in people with heart failure who have a severely weakened heart. Researchers want to understand how this drug affects serious heart-related events over time. The study is sponsored by Cytokinetics and aims to provide new information for patients with this condition.

Who may be eligible for this heart failure clinical trial?

Adults between 18 and 85 years with chronic heart failure and severely reduced heart function may be eligible. Participants need to be on regular oral diuretics and have had recent heart failure events or worsening symptoms. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 18Years - 85Years

All Genders

ID06736574

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

Led by Cytokinetics · Updated on 2026-05-05

1800

Participants Needed

185

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the drug omecamtiv mecarbil to see if it can reduce the risks associated with heart failure in patients who have severely reduced heart pumping ability, known as ejection fraction. This phase 3 study focuses on whether the drug can lower the chances of cardiovascular death, heart failure events, the need for heart assist devices or transplantation, and stroke in symptomatic patients. The study is supported by Cytokinetics and is designed to provide important information on how this drug may affect these serious outcomes. Participants will be randomly assigned to one of two groups one group will receive omecamtiv mecarbil tablets at doses of 25, 37.5, or 50 mg twice daily based on blood levels of the drug, while the other group will receive placebo tablets twice daily. Treatment will continue until at least 850 participants have experienced a heart failure event or cardiovascular death. The study includes a plan for an interim review based on these events and is expected to last about three years. During the study, participants will be closely monitored for heart failure events, cardiovascular death, stroke, and other serious outcomes. Researchers will measure the time until the first occurrence of these events from the start of treatment. Regular assessments will evaluate safety and treatment effects. The total participation time for each person may be up to three years, with ongoing follow-up until the study ends.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged between 18 and 85 years at the time of consent
Have chronic heart failure with reduced ejection fraction for at least 3 months before screening
Currently taking oral loop diuretics on a regular schedule
For patients without atrial fibrillation/flutter (AFF) on screening ECG: left ventricular ejection fraction (LVEF) less than 30% within 6 months, and elevated NT-proBNP 1000 pg/mL (BNP 300 pg/mL)
For patients with AFF on screening ECG: LVEF less than 25% within 6 months, NT-proBNP 3000 pg/mL (BNP 900 pg/mL), and not currently taking digoxin
Have had a recent heart failure event such as current hospitalization for heart failure, or heart failure event within 12 months, or outpatient worsening requiring increased diuretic treatment for at least 1 week
Established on standard heart failure therapies for at least 30 days prior to screening
Systolic blood pressure 140 mmHg

You will not qualify if you...

Have atrial fibrillation/flutter on screening ECG and are currently taking digoxin
Had recent events or procedures affecting heart function within 3 months, such as acute coronary syndrome, cardiac surgery, valve surgery, or cardiac device therapies
Currently admitted to long-term care or hospice
Have a life expectancy less than 12 months due to non-heart related causes
Receiving intravenous inotropes or vasopressors within 3 days prior to screening
Receiving mechanical heart support or ventilation within 7 days prior to screening
Receiving intravenous diuretics, vasodilators, or oxygen therapy within 12 hours prior to screening (except for nighttime oxygen for sleep apnea or heart failure)
Have severely reduced kidney function (eGFR less than 20 mL/min/1.73m2) or are on dialysis
Have had a solid organ transplant before
Are currently in or recently ended participation in another investigational drug or device study within 30 days
Have previously received omecamtiv mecarbil in a past trial
Are pregnant, planning pregnancy, or breastfeeding during the study or within 5 days after treatment ends
Have primary infiltrative heart disease or severe valve disease

Research Team

Cytokinetics MD

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