FINALITY-HF
Research type
Research Study
Full title
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)
IRAS ID
1011499
Contact name
Vanessa Carrillo Cisneros Cisneros
Contact email
Sponsor organisation
CPC Clinical Research
Eudract number
2023-508875-35
Clinicaltrials.gov Identifier
Research summary
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonist (sMRA).
Medical guidelines in Europe and the US recommend a family of medications called mineralocorticoid receptor antagonists (MRAs) to reduce hospitalization and improve survival in patients with heart failure. Earlier generation MRAs (such as spironolactone or eplerenone) are not suitable for or tolerated by some patients due to their side effect profile (including high potassium levels in the blood, low blood pressure, sexual side effects such as breast tissue development in men, and worsening kidney function). Finerenone is a next generation (newer) MRA drug developed to avoid or minimize these side effects. This study will find out whether finerenone can lower the risk of heart failure and death in patients with heart failure who are unable to take the earlier generation MRAs. Approximately 2600 participants are expected to take part in the study.
Finerenone is produced by Bayer and has been shown to lower the risk of heart attack, cardiovascular death, kidney failure, and heart failure in patients with type 2 diabetes and kidney disease. It is approved for treatment of patients with type 2 diabetes and chronic kidney disease by health agencies throughout the world, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The use of finerenone in this study is investigational for heart failure.REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0025
Date of REC Opinion
4 Mar 2025
REC opinion
Further Information Favourable Opinion