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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519219-32-00

Acronym

CY 1033

Enrollment

770

Registered

2025-06-03

Start date

2025-06-23

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Reduced Ejection Fraction

Brief summary

Time to the first event of the following components: • CV death • HF event

Detailed description

1. Time to first HF event, CV death, LVAD implantation/transplantation or stroke, 2. Time to the first HF hospitalization, 3. Time to the first HF event, CV death, LVAD implantation/cardiac transplant, or stroke in a subgroup of patients with severe heart failure, 4. Time to the first event of irreversible morbidity/mortality, 5. Time to CV death, 6. Time to first event of stroke, 7. Time to all-cause death

Interventions

DRUGOmecamtiv Mecarbil

DRUGMatching Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to the first event of the following components: • CV death • HF event	—

Secondary

Measure	Time frame
1. Time to first HF event, CV death, LVAD implantation/transplantation or stroke, 2. Time to the first HF hospitalization, 3. Time to the first HF event, CV death, LVAD implantation/cardiac transplant, or stroke in a subgroup of patients with severe heart failure, 4. Time to the first event of irreversible morbidity/mortality, 5. Time to CV death, 6. Time to first event of stroke, 7. Time to all-cause death	—

Measure

Time frame

—

Countries

France, Germany, Greece, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026