Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCytokinetics
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
LVEF < 30% within 6 months of screening
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Omecamtiv Mecarbil (OM)
DrugOral Tablet
Placebo
DrugOral Tablet
Treatment groups
1,800 Participants
are divided into 2 treatment groupsGroup A: Omecamtiv MecarbilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
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.
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 yearsSecondary outcomes
1
Time to the first event of CV death or HF event
Effect of omecamtiv mecarbil compared with placebo on risk of CV death and HF event
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 years2
Time to the first HF hospitalization
Effect of omecamtiv mecarbil compared with placebo on risk of HF hospitalization
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 years3
Time to the first event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke in a subgroup of patients with severe HF
Effect of omecamtiv mecarbil compared with placebo on risk of HF outcomes in patients with severe HF, defined as patients with NYHA class 3-4 symptoms and a HF event within the last 3 months
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 years4
Time to the first event of CV death, LVAD implantation/cardiac transplantation, or stroke
Effect of omecamtiv mecarbil compared with placebo on risk of irreversible morbidity/mortality related to HFrEF
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 yearsSponsors and contacts
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Source ClinicalTrials.gov