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A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

NCT06008197 · Colorado Prevention Center
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Official 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)
About this study
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA) * Documented prior history of severe hyperkalemia in the setting of MRA use * Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or potassium \>5.0 mmol/L at screening * Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days * Hemodynamically significant (severe) uncorrected primary cardiac valvular disease * Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction * Probable alternative cause of participant's heart failure symptoms * Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers * Known hypersensitivity to the IP (active substance or excipients)
Study design
Enrollment target: 5200 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-01-17
Estimated completion: 2027-12
Last updated: 2026-02-20
Interventions
Drug: FinerenoneDrug: Placebo
Primary outcomes
  • Composite of total HF events and cardiovascular (CV) death. (Ongoing, up to ~30 months)
  • Number of serious adverse events. (Ongoing, up to ~30 months)
  • Number of adverse events leading to discontinuation of study drug. (Ongoing, up to ~30 months)
Sponsor
Colorado Prevention Center · other
With: St. Luke's Hospital, Kansas City, Missouri, Bayer
Contacts & investigators
ContactMarc Bonaca · contact · info@cpcmed.org · 303-860-9900
All locations (80)
Glendale, AZ Investigative Site 10096Recruiting
Glendale, Arizona, United States
Huntington Beach, CA Investigative Site 10031Recruiting
Huntington Beach, California, United States
Los Angeles, CA Investigative Site 10089Recruiting
Los Angeles, California, United States
Brooksville, FL Investigative Site 10077Recruiting
Brooksville, Florida, United States
Miramar, FL Investigative Site 10113Not Yet Recruiting
Miramar, Florida, United States
Boise, Idaho Investigative Site 10073Recruiting
Boise, Idaho, United States
Chicago, IL Investigative Site 10062Recruiting
Chicago, Illinois, United States
Indianapolis, IN Investigative Site 10074Recruiting
Indianapolis, Indiana, United States
Indianapolis, IN Investigative Site 10008Recruiting
Indianapolis, Indiana, United States
Merrillville, IN Investigative Site 10064Recruiting
Merrillville, Indiana, United States
Louisville, KY Investigative Site 10006Recruiting
Louisville, Kentucky, United States
Louisville, KY Investigative Site 10086Not Yet Recruiting
Louisville, Kentucky, United States
Paducah, KY Investigative Site 10079Recruiting
Paducah, Kentucky, United States
Boston, MA Investigative Stie 10087Recruiting
Boston, Massachusetts, United States
Minneapolis, MN Investigative Site 10091Recruiting
Minneapolis, Minnesota, United States
Tupelo, MS Investigative Site 10100Not Yet Recruiting
Tupelo, Mississippi, United States
Stony Brook, NY Investigative Site 10017Recruiting
Stony Brook, New York, United States
Centerville, OH Investigative Site 10119Recruiting
Centerville, Ohio, United States
Cincinnati, OH Investigative Site 10088Recruiting
Cincinnati, Ohio, United States
Bartlesville, OK Investigative Site 10095Recruiting
Bartlesville, Oklahoma, United States
Charleston, SC Investigative Site 10056Recruiting
Charleston, South Carolina, United States
Memphis, TN Investigative Site 10059Recruiting
Memphis, Tennessee, United States
Burlington, VT Investigative Site 10053Recruiting
Burlington, Vermont, United States
Salem, VA Investigative Site 10048Recruiting
Salem, Virginia, United States
Milwaukee, WI Investigative Site 10061Recruiting
Milwaukee, Wisconsin, United States
Córdoba, Córdoba Investigative Site 20014Recruiting
Córdoba, Córdoba Province, Argentina
Melbourne, VIC Investigative Site 50005Recruiting
Melbourne, Victoria, Australia
Fortaleza, Ceará Investigative Site 21055Active Not Recruiting
Fortaleza, Ceará I, Brazil
Salvador, Bahia Investigative Site 21032Recruiting
Salvador, Estado de Bahia, Brazil
Belo Horizonte, Minais Gerais Investigative Site 21013Recruiting
Belo Horizonte, Minais Gerais, Brazil
Belo Horizonte, Minas Gerais Investigative Site 21051Recruiting
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná Investigative Site 21038Recruiting
Curitiba, Paraná, Brazil
Teresina, Piaui Investigative Site 21050Recruiting
Teresina, Piauí, Brazil
Recife, Recife Investigative Site 21001Recruiting
Recife, Recife, Brazil
Rio De Janeiro, Rio De Janeiro Investigative Site 21016Recruiting
Rio de Janeiro, Rio de Janeiro, Brazil
Passo Fundo, Rio Grande do Sul Investigative Site 21042Recruiting
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul Investigative Site 21025Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Aracaju, Sergipe Investigative Site 21058Recruiting
Aracaju, Sergipe, Brazil
Aracaju, Sergipe Investigative Site 21015Recruiting
Aracaju, Sergipe, Brazil
Atibaia, São Paulo Investigative Site 21057Recruiting
Atibaia, São Paulo, Brazil
Santo André, Sao Paulo Investigative Site 21043Not Yet Recruiting
Santo André, São Paulo, Brazil
São José Dos Campos, Sao Paulo Investigative Site 21012Recruiting
São José dos Campos, São Paulo, Brazil
São Paulo, São Paulo Investigative Site 21062Recruiting
São Paulo, São Paulo, Brazil
São Paulo, São Paulo Investigative Site 21048Recruiting
São Paulo, São Paulo, Brazil
São Paulo, São Paulo Investigative Site 21041Recruiting
São Paulo, São Paulo, Brazil
São Paulo, São Paulo Investigative Site 21035Recruiting
São Paulo, São Paulo, Brazil
São Paulo, São Paulo Investigative Site 21049Recruiting
São Paulo, São Paulo, Brazil
Edmonton, AB Investigative Site 11018Recruiting
Edmonton, Alberta, Canada
Edmonton, Alberta Investigative Site 11011Recruiting
Edmonton, Alberta, Canada
Kamloops, BC Investigative Site 11021Recruiting
Kamloops, British Columbia, Canada
North Vancouver, BC Investigative Site11020Not Yet Recruiting
North Vancouver, British Columbia, Canada
Surrey, British Columbia Investigative Site 11012Recruiting
Surrey, British Columbia, Canada
Vancouver, BC Investigative Site 11017Recruiting
Vancouver, British Columbia, Canada
Cambridge, ON Investigative Site 11003Recruiting
Cambridge, Ontario, Canada
Sudbury, ON Investigative Site 11016Recruiting
Greater Sudbury, Ontario, Canada
North York, Ontario Investigative Site 11007Recruiting
North York, Ontario, Canada
Toronto, Ontario Investigative Site 11008Recruiting
Toronto, Ontario, Canada
Toronto, ON Investigative Site 11019Recruiting
Toronto, Ontario, Canada
Regina, SK Investigative Site 11022Recruiting
Regina, Saskatchewan, Canada
Zagreb, Grad Zagreb Investigative Site 30005Recruiting
Zagreb, Croatia, Croatia
Chlumec nad Cidlinou, Czech Republic Investigative Site 31005Recruiting
Chlumec nad Cidlinou, Czech Republic, Czechia
Plzeň, Czech Republic Investigative Site 31006Recruiting
Pilsen, Czech Republic, Czechia
Berlin, Berlin Investigative Site 32001Recruiting
Berlin, State of Berlin, Germany
Athens, Investigative Site 33007Recruiting
Athens, Greece, Greece
Ahmedabad, Gujarat Investigative Site 51006Recruiting
Ahmedabad, Gujarat, India
Chennai, Tamil Nadu Investigative site 51008Recruiting
Chennai, Tamil Nadu, India
Varese, Varese Investigative Site 35004Recruiting
Varese, Varese, Italy
Alytus, Lithuania Investigative Site 36005Recruiting
Alytus, Lithuania, Lithuania
Alor Setar, Kedah Investigative Site 52006Recruiting
Alor Star, Kedah, Malaysia
Kuala Lumpur, Wilayah Persekutuan Investigative Site 52007Recruiting
Kuala Lumpur, Kuala Lumpur, Malaysia
Kuantan, Pahang Investigative Site 52004Recruiting
Kuantan, Pahang, Malaysia
Kajang, Selangor Investigative Site 52008Recruiting
Kajang, Selangor, Malaysia
CULIACÁN, Flores Investigative Site 23002Not Yet Recruiting
Culiacán, Flores, Mexico
Morelia, Michoacan Investigative Site 23007Not Yet Recruiting
Morelia, Michoacán, Mexico
Culiacan, Sinaloa Investigative Site 23006Recruiting
Culiacán, Sinaloa, Mexico
Lima, Lima Investigative Site 24011Recruiting
Lima, Lima Province, Peru
Seodaemun-gu, Seoul Investigative Site 53001Recruiting
Seoul, Seoul, South Korea
Santiago De Compostela, Galicia Investigative Site 38008Recruiting
Santiago de Compostela, Galicia, Spain
Barcelona, Spain Investigative Site 38010Recruiting
Barcelona, Spain, Spain
Taipei, Taiwan Investigative Site 55008Recruiting
Taipei, Taiwan, Taiwan