REDEFINE-HF
Research type
Research Study
Full title
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)
IRAS ID
1009334
Contact name
Andrejs Faibusevics
Contact email
Sponsor organisation
CPC Clinical Research
Eudract number
2023-508581-15
Clinicaltrials.gov Identifier
Research summary
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment hospitalized heart failure patients with mildly reduced or preserved ejection fraction.
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
The trial is sponsored by CPC Clinical Research, an academic research organization affiliated with University of Colorado and performed at study sites globally.
This is a randomized study and if the patient meets all eligibility criteria he/she will be enrolled into the study, in which participants will receive the study drug finerenone or matching placebo.
The primary objective of the trial is to determine whether finerenone reduces heart failure events and CV death compared with placebo in patients hospitalized with acute decompensated heart failure with moderately reduced or preserved ejection fraction.
Participation in this clinical trial will in no way preclude access to standard care for your patient. He/she will obtain the best opportunities for assistance and treatment currently available.
Personal data of participants collected for the purpose of conducting the research will be treated in full compliance with the laws and regulations in force. The results of the study may be published, but patient‘s identity will not be disclosed.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
24/EM/0055
Date of REC Opinion
24 Apr 2024
REC opinion
Further Information Favourable Opinion