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Cardiac Myosin Activator
Omecamtiv Mecarbil for Heart Failure (COMET-HF Trial)
Phase 3
Recruiting
Research Sponsored by Cytokinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to the first event of cv death, hf event, lvad implantation, cardiac transplantation, or stroke, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
Awards & highlights
Pivotal Trial
Summary
This trial aims to determine if a new drug, omecamtiv mecarbil, can lower the chances of hospitalization, heart transplantation, or death in patients with heart failure and severely reduced heart
Who is the study for?
This trial is for people with chronic heart failure who have a severely reduced ejection fraction, which means their hearts are not pumping blood well. Participants should meet specific health criteria but the provided details on eligibility are incomplete.
What is being tested?
The study is testing Omecamtiv Mecarbil (OM), an experimental drug, to see if it can help reduce complications from heart failure like hospital stays, needing a transplant, or risk of death. Some participants will receive OM while others will get a placebo for comparison.
What are the potential side effects?
Specific side effects of Omecamtiv Mecarbil aren't listed here, but common side effects in heart failure treatments may include changes in blood pressure, dizziness, abnormal heart rhythms, and potential kidney problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to the first event of cv death, hf event, lvad implantation, cardiac transplantation, or stroke, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to the first event of cv death, hf event, lvad implantation, cardiac transplantation, or stroke, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
Secondary study objectives
Time to CV death
Time to all-cause death
Time to first event of Stroke
+4 moreSide effects data
From 2020 Phase 1 trial • 70 Patients • NCT041758086%
Post procedural complication
4%
Oropharyngeal pain
3%
Rash papular
3%
Post procedural erythema
1%
Headache
1%
Insomnia
1%
Nasal congestion
1%
Rash
1%
Nausea
1%
Nasopharyngitis
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part B: Placebo
Part A: Omecamtiv Mecarbil 25 mg
Overall
Part B: Omecamtiv Mecarbil 50 mg
Part B: Moxifloxacin 400 mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Omecamtiv MecarbilExperimental Treatment1 Intervention
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 primary composite endpoint events have occurred.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to placebo will receive placebo twice daily until at least 850 primary composite endpoint events have occurred.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omecamtiv Mecarbil (OM)
2019
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
CytokineticsLead Sponsor
42 Previous Clinical Trials
15,634 Total Patients Enrolled
13 Trials studying Heart Failure
9,995 Patients Enrolled for Heart Failure
Cytokinetics MDStudy DirectorCytokinetics
4 Previous Clinical Trials
813 Total Patients Enrolled