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 (78) 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
Arizona
Glendale, AZ Investigative Site 10096
RECRUITING
Glendale
California
Huntington Beach, CA Investigative Site 10031
RECRUITING
Huntington Beach
Los Angeles, CA Investigative Site 10089
RECRUITING
Los Angeles
Florida
Brooksville, FL Investigative Site 10077
RECRUITING
Brooksville
Miramar, FL Investigative Site 10113
NOT_YET_RECRUITING
Miramar
Idaho
Boise, Idaho Investigative Site 10073
RECRUITING
Boise
Illinois
Chicago, IL Investigative Site 10062
RECRUITING
Chicago
Indiana
Indianapolis, IN Investigative Site 10008
RECRUITING
Indianapolis
Indianapolis, IN Investigative Site 10074
RECRUITING
Indianapolis
Merrillville, IN Investigative Site 10064
RECRUITING
Merrillville
Kentucky
Louisville, KY Investigative Site 10006
RECRUITING
Louisville
Louisville, KY Investigative Site 10086
NOT_YET_RECRUITING
Louisville
Paducah, KY Investigative Site 10079
RECRUITING
Paducah
Massachusetts
Boston, MA Investigative Stie 10087
RECRUITING
Boston
Minnesota
Minneapolis, MN Investigative Site 10091
RECRUITING
Minneapolis
Mississippi
Tupelo, MS Investigative Site 10100
NOT_YET_RECRUITING
Tupelo
New York
Stony Brook, NY Investigative Site 10017
RECRUITING
Stony Brook
Ohio
Centerville, OH Investigative Site 10119
RECRUITING
Centerville
Cincinnati, OH Investigative Site 10088
RECRUITING
Cincinnati
Oklahoma
Bartlesville, OK Investigative Site 10095
RECRUITING
Bartlesville
South Carolina
Charleston, SC Investigative Site 10056
RECRUITING
Charleston
Tennessee
Memphis, TN Investigative Site 10059
RECRUITING
Memphis
Virginia
Salem, VA Investigative Site 10048
RECRUITING
Salem
Vermont
Burlington, VT Investigative Site 10053
RECRUITING
Burlington
Wisconsin
Milwaukee, WI Investigative Site 10061
RECRUITING
Milwaukee
Other Locations
Argentina
Córdoba, Córdoba Investigative Site 20014
RECRUITING
Córdoba
Australia
Melbourne, VIC Investigative Site 50005
RECRUITING
Melbourne
Brazil
Aracaju, Sergipe Investigative Site 21015
RECRUITING
Aracaju
Aracaju, Sergipe Investigative Site 21058
RECRUITING
Aracaju
Atibaia, São Paulo Investigative Site 21057
RECRUITING
Atibaia
Belo Horizonte, Minais Gerais Investigative Site 21013
RECRUITING
Belo Horizonte
Belo Horizonte, Minas Gerais Investigative Site 21051
RECRUITING
Belo Horizonte
Curitiba, Paraná Investigative Site 21038
RECRUITING
Curitiba
Fortaleza, Ceará Investigative Site 21055
ACTIVE_NOT_RECRUITING
Fortaleza
Passo Fundo, Rio Grande do Sul Investigative Site 21042
RECRUITING
Passo Fundo
Porto Alegre, Rio Grande do Sul Investigative Site 21025
RECRUITING
Porto Alegre
Recife, Recife Investigative Site 21001
RECRUITING
Recife
Rio De Janeiro, Rio De Janeiro Investigative Site 21016
RECRUITING
Rio De Janeiro
Salvador, Bahia Investigative Site 21032
RECRUITING
Salvador
Santo André, Sao Paulo Investigative Site 21043
NOT_YET_RECRUITING
Santo André
São José Dos Campos, Sao Paulo Investigative Site 21012
RECRUITING
São José Dos Campos
São Paulo, São Paulo Investigative Site 21035
RECRUITING
São Paulo
São Paulo, São Paulo Investigative Site 21041
RECRUITING
São Paulo
São Paulo, São Paulo Investigative Site 21048
RECRUITING
São Paulo
São Paulo, São Paulo Investigative Site 21049
RECRUITING
São Paulo
São Paulo, São Paulo Investigative Site 21062
RECRUITING
São Paulo
Teresina, Piaui Investigative Site 21050
RECRUITING
Teresina
Canada
Cambridge, ON Investigative Site 11003
RECRUITING
Cambridge
Edmonton, AB Investigative Site 11018
RECRUITING
Edmonton
Edmonton, Alberta Investigative Site 11011
RECRUITING
Edmonton
Sudbury, ON Investigative Site 11016
RECRUITING
Greater Sudbury
Kamloops, BC Investigative Site 11021
RECRUITING
Kamloops
North Vancouver, BC Investigative Site11020
NOT_YET_RECRUITING
North Vancouver
North York, Ontario Investigative Site 11007
RECRUITING
North York
Regina, SK Investigative Site 11022
RECRUITING
Regina
Surrey, British Columbia Investigative Site 11012
RECRUITING
Surrey
Toronto, ON Investigative Site 11019
RECRUITING
Toronto
Toronto, Ontario Investigative Site 11008
RECRUITING
Toronto
Vancouver, BC Investigative Site 11017
RECRUITING
Vancouver
Croatia
Zagreb, Grad Zagreb Investigative Site 30005
RECRUITING
Zagreb
Germany
Berlin, Berlin Investigative Site 32001
RECRUITING
Berlin
Greece
Athens, Investigative Site 33007
RECRUITING
Athens
India
Ahmedabad, Gujarat Investigative Site 51006
RECRUITING
Ahmedabad
Chennai, Tamil Nadu Investigative site 51008
RECRUITING
Chennai
Italy
Varese, Varese Investigative Site 35004
RECRUITING
Varese
Lithuania
Alytus, Lithuania Investigative Site 36005
RECRUITING
Alytus
Malaysia
Alor Setar, Kedah Investigative Site 52006
RECRUITING
Alor Star
Kajang, Selangor Investigative Site 52008
RECRUITING
Kajang
Kuala Lumpur, Wilayah Persekutuan Investigative Site 52007
RECRUITING
Kuala Lumpur
Kuantan, Pahang Investigative Site 52004
RECRUITING
Kuantan
Mexico
CULIACÁN, Flores Investigative Site 23002
NOT_YET_RECRUITING
Culiacán
Culiacan, Sinaloa Investigative Site 23006
RECRUITING
Culiacán
Morelia, Michoacan Investigative Site 23007
NOT_YET_RECRUITING
Morelia
Peru
Lima, Lima Investigative Site 24011
RECRUITING
Lima
Republic of Korea
Seodaemun-gu, Seoul Investigative Site 53001
RECRUITING
Seoul
Spain
Barcelona, Spain Investigative Site 38010
RECRUITING
Barcelona
Santiago De Compostela, Galicia Investigative Site 38008
RECRUITING
Santiago De Compostela
Taiwan
Taipei, Taiwan Investigative Site 55008
RECRUITING
Taipei
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