RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure (REDEFINE-HF)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508581-15-00

Acronym

202301CPC

Enrollment

1136

Registered

2024-06-24

Start date

2024-10-08

Completion date

Unknown

Last updated

2025-12-15

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

Conditions

Heart condition

Brief summary

The primary study endpoint is a composite of total (first and subsequent) HF events (HF hospitalization or urgent visit for worsening HF) and CV death.

Detailed description

Secondary endpoints include treatment group difference in: 1.Time to first occurrence of the composite of CV death or HF event; 2. Total HF events; 3. Change from baseline to month 6 in KCCQ-TSS; 4. Time to CV death 5. Time to death from any cause

Interventions

DRUGFinerenone

DRUGBAY 94-8862

DRUGBAY 94-8862 coated tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Secondary endpoints include treatment group difference in: 1.Time to first occurrence of the composite of CV death or HF event; 2. Total HF events; 3. Change from baseline to month 6 in KCCQ-TSS; 4. Time to CV death 5. Time to death from any cause	—

Primary

Measure	Time frame
The primary study endpoint is a composite of total (first and subsequent) HF events (HF hospitalization or urgent visit for worsening HF) and CV death.	—

Countries

Croatia, Czechia, Germany, Greece, Hungary, Italy, Lithuania, Poland, Spain

Outcome results

None listed

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