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 (309) 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 written informed consent
• Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
• Current hospitalization or recently discharged (during or within 30 days of discharge) 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) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF
Locations
United States
Alabama
Birmingham, AL Investigative Site 10012
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Birmingham
Fairhope, AL Investigative Site 10004
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Fairhope
Huntsville, AL Investigative Site 10026
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Huntsville
Arizona
Glendale, AZ Investigative Site 10096
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Glendale
Phoenix, AZ Investigative Site 10115
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Phoenix
Scottsdale, AZ Investigative Site 10003
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Scottsdale
California
Chula Vista, CA Investigative Site 10111
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Chula Vista
Huntington Beach, CA Investigative Site 10031
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Huntington Beach
Los Angeles, CA Investigative Site 10089
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Los Angeles
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Sacramento
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San Francisco
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Tarzana
Van Nuys, CA Investigative Site 10109
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Van Nuys
West Hills, CA Investigative Site 10013
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West Hills
Colorado
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Aurora
Denver, CO Investigative Site 10005
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Denver
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Bradenton
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Brooksville
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Indianapolis
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Merrillville
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Cynthiana
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Lexington
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Paducah
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Baton Rouge
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Boston
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Bowie
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Kansas City
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Omaha
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Malaysia
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Ashford
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Brighton
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Cardiff
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Chester
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Dudley
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Glasgow
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London
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London
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Manchester
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Plymouth
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Southampton
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Swindon
Contact Information
Primary
Marc Bonaca
info@cpcmed.org
303-860-9900
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2027-12
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