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
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Provide electronic or written informed consent, either personally or through a legally authorized representative

• Age ≥18 years

• Current hospitalization or recently discharged with the primary diagnosis of heart failure

• Heart failure signs and symptoms at the time of hospital admission

• Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)

• Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF

Locations
United States
Colorado
Aurora, CO Investigative Site
NOT_YET_RECRUITING
Aurora
Denver, CO Investigative Site
NOT_YET_RECRUITING
Denver
Florida
Boca Raton, FL Investigative Site
RECRUITING
Boca Raton
Missouri
Kansas City, MO Investigative Site
RECRUITING
Kansas City
Contact Information
Primary
Marc Bonaca
info@cpcmed.org
303-860-9900
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2026-04
Participants
Target number of participants: 5200
Treatments
Experimental: Finerenone
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: St. Luke's Hospital, Kansas City, Missouri, Bayer
Leads: Colorado Prevention Center

This content was sourced from clinicaltrials.gov