NCT06736574 · Cytokinetics
Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
(COMET-HF)
What this study is about
The purpose of this study is to find out if the experimental 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.
View original scientific description
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.
Interventions
DRUG
Omecamtiv Mecarbil (OM)
Oral Tablet
DRUG
Placebo
Oral Tablet
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Are currently hospitalized with the primary reason of HF, or had an HF event within 6 months prior to screening
- Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
- Systolic blood pres
Where
- Alexander City, Alabama
- Birmingham, Alabama
- Tucson, Arizona
- Beverly Hills, California
- La Jolla, California
- Loma Linda, California
- Los Angeles, California
- Orange, California
- Sacramento, California
- San Diego, California
- San Francisco, California
- Santa Clara, California
And 68 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations