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

Conditions

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Omecamtiv Mecarbil (OM) — DRUG
  Oral Tablet
• Placebo — DRUG
  Oral Tablet

Study Details

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.

Key Dates

Start date

Dec 19, 2024

Status verified

Feb 2026

Primary completion

Sep 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

1,800 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Omecamtiv Mecarbil
  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 participants experience a HF event or CV death, whichever comes first.
• Placebo Comparator: Placebo
  Participants randomized to placebo will receive placebo twice daily until at least 850 participants experience a HF event or CV death, whichever comes first.

Primary Outcome Measure

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 ]

Central Contacts

• Cytokinetics MD
  (650) 624-2929
  [email protected]

Locations (88)

Find similar trials in Alexander City, AL

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