A randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists (FINALITY-HF)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508875-35-00

Acronym

202304CPC

Enrollment

740

Registered

2025-06-20

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-01-13

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 endpoint is the time to first occurrence of cardiovascular death or a heart failure event.

Detailed description

Secondary endpoints include treatment group differences in: Timing and occurrence of total (first and recurrent) events of cardiovascular (CV) death and heart failure (HF) events. Timing and occurrence of total (first and recurrent) HF events. Change in Kansas City Cardiomyopathy Questionnaire – Total Symptom Score (KCCQ-TSS) from baseline to Month 6. Time to CV death. Time to all-cause death.

Interventions

DRUGFinerenone

DRUGPlacebo for bay 94-8862

DRUGBAY 94-8862

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the time to first occurrence of cardiovascular death or a heart failure event.	—

Secondary

Measure	Time frame
Secondary endpoints include treatment group differences in: Timing and occurrence of total (first and recurrent) events of cardiovascular (CV) death and heart failure (HF) events. Timing and occurrence of total (first and recurrent) HF events. Change in Kansas City Cardiomyopathy Questionnaire – Total Symptom Score (KCCQ-TSS) from baseline to Month 6. Time to CV death. Time to all-cause death.	—

Countries

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

Outcome results

None listed

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