Testing Omecamtiv Mecarbil (OM) against a placebo for heart failure
Official title: 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)
Interventions
Omecamtiv Mecarbil (OM)
Oral Tablet
Placebo
Oral Tablet
Canadian Sites (15)
Mazankowski Alberta Heart Institute / University of Alberta Hospital
Edmonton, Alberta, Canada
Kelowna General Hospital
Kelowna, British Columbia, Canada
SMH - Cardiology Clinical Trials Inc.
Surrey, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Oakville Trafalgar Memorial Hospital - Halton Healthcare
Oakville, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
UHN-Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec, Canada
CISSSL - Hopital Pierre-Le Gardeur
Terrebonne, Quebec, Canada
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Adult patients who meet all the following criteria at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → may be included in the study:
- +Are between ≥ 18 years and ≤ 85 years at the signing of informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +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 endpointPrimary endpointThe single main question the study is designed to answer.Read more →) 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
- −Any of the following criteria will exclude potential patients from the study:
- −Have AFF on the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → ECG and are currently taking digoxin
- −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 trialInterventional studyA study where participants are given something to see what happens.Read more →
- −Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease
- −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 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Omecamtiv Mecarbil (OM), PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 85 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,800 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke — measured over From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06736574 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Omecamtiv Mecarbil (OM)Drug
Oral Tablet
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Oral Tablet
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 85 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 85 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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.
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 19 locations, including: Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada; Winnipeg, Manitoba, Canada, and 13 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (7)
Henry Ford Hospital
Detroit, Michigan, United States
Capital Cardiology Associates
Albany, New York, United States
Northwell Health North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center / New York - Presbyterian
New York, New York, United States
Montefiore Medical Center (Moses Campus)
The Bronx, New York, United States
Providence Advanced Heart Disease and Transplant
Spokane, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.