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Clinical Trial NCT06008197 (REDEFINE-HF) for Heart Failure, Acute Heart Failure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF) Phase 3 5,200 Paid Participation

Recruiting
Clinical Trial NCT06008197 (REDEFINE-HF) is designed to study Treatment for Heart Failure, Acute Heart Failure. It is a Phase 3 interventional study that is recruiting, having started on 17 January 2024, with plans to enroll 5,200 participants. Led by Colorado Prevention Center, it is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 20 February 2026.
Brief 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.
Detailed Description
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.
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)

Conditions
Heart FailureAcute Heart Failure
Other Study IDs
  • REDEFINE-HF
  • 202301CPC
NCT ID Number
NCT06008197
Start Date (Actual)
2024-01-17
Last Update Posted
2026-02-20
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
5,200
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
Heart failure
Preserved ejection fraction
Mildly reduced ejection fraction
Hospitalized
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalFinerenone
Finerenone
Oral finerenone
Placebo ComparatorPlacebo
Placebo
Matching oral placebo
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Composite of total HF events and cardiovascular (CV) death.
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of serious adverse events.
Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Ongoing, up to ~30 months
Number of adverse events leading to discontinuation of study drug.
Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
Ongoing, up to ~30 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time to first occurrence of the composite of CV death or HF event.
Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
Ongoing, up to ~30 months
Total HF events.
Total HF events with finerenone compared to placebo.
Ongoing, up to ~30 months
Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
6 Months
Time to CV death.
Time to CV death with finerenone compared to placebo.
Ongoing, up to ~30 months
Time to death from any cause.
Time to death from any cause with finerenone compared to placebo.
Ongoing, up to ~30 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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)
Colorado Prevention Center logoColorado Prevention Center
Study Central Contact
Contact: Marc Bonaca, 303-860-9900, [email protected]
80 Study Locations in 18 Countries

Victoria

Melbourne, VIC Investigative Site 50005, Melbourne, Victoria, 3121, Australia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Arizona

Glendale, AZ Investigative Site 10096, Glendale, Arizona, 85304, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

California

Huntington Beach, CA Investigative Site 10031, Huntington Beach, California, 92648, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Los Angeles, CA Investigative Site 10089, Los Angeles, California, 90073, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Florida

Brooksville, FL Investigative Site 10077, Brooksville, Florida, 34613, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Miramar, FL Investigative Site 10113, Miramar, Florida, 33027, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Not yet recruiting

Idaho

Boise, Idaho Investigative Site 10073, Boise, Idaho, 83712, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Illinois

Chicago, IL Investigative Site 10062, Chicago, Illinois, 60612, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Indiana

Indianapolis, IN Investigative Site 10074, Indianapolis, Indiana, 46237, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Indianapolis, IN Investigative Site 10008, Indianapolis, Indiana, 46260, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Merrillville, IN Investigative Site 10064, Merrillville, Indiana, 46410, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Kentucky

Louisville, KY Investigative Site 10006, Louisville, Kentucky, 40202, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Louisville, KY Investigative Site 10086, Louisville, Kentucky, 40205, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Not yet recruiting
Paducah, KY Investigative Site 10079, Paducah, Kentucky, 42003, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Massachusetts

Boston, MA Investigative Stie 10087, Boston, Massachusetts, 02114, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Minnesota

Minneapolis, MN Investigative Site 10091, Minneapolis, Minnesota, 55407-1139, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Mississippi

Tupelo, MS Investigative Site 10100, Tupelo, Mississippi, 38801, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Not yet recruiting

New York

Stony Brook, NY Investigative Site 10017, Stony Brook, New York, 11794-8171, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Ohio

Centerville, OH Investigative Site 10119, Centerville, Ohio, 45459, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Cincinnati, OH Investigative Site 10088, Cincinnati, Ohio, 45220, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Oklahoma

Bartlesville, OK Investigative Site 10095, Bartlesville, Oklahoma, 74006, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

South Carolina

Charleston, SC Investigative Site 10056, Charleston, South Carolina, 29425, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Tennessee

Memphis, TN Investigative Site 10059, Memphis, Tennessee, 38105, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Vermont

Burlington, VT Investigative Site 10053, Burlington, Vermont, 05401, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Virginia

Salem, VA Investigative Site 10048, Salem, Virginia, 24153, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Wisconsin

Milwaukee, WI Investigative Site 10061, Milwaukee, Wisconsin, 53226, United States
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Córdoba Province

Córdoba, Córdoba Investigative Site 20014, Córdoba, Córdoba Province, 5003, Argentina
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Ceará I

Fortaleza, Ceará Investigative Site 21055, Fortaleza, Ceará I, 60864-190, Brazil
Active, not recruiting

Estado de Bahia

Salvador, Bahia Investigative Site 21032, Salvador, Estado de Bahia, 40050-410, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Minais Gerais

Belo Horizonte, Minais Gerais Investigative Site 21013, Belo Horizonte, Minais Gerais, 30441-070, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Minas Gerais

Belo Horizonte, Minas Gerais Investigative Site 21051, Belo Horizonte, Minas Gerais, 30220140, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Paraná

Curitiba, Paraná Investigative Site 21038, Curitiba, Paraná, 80230-130, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Piauí

Teresina, Piaui Investigative Site 21050, Teresina, Piauí, 64001-450, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Recife

Recife, Recife Investigative Site 21001, Recife, Recife, 50720-110, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Rio de Janeiro

Rio De Janeiro, Rio De Janeiro Investigative Site 21016, Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Rio Grande do Sul

Passo Fundo, Rio Grande do Sul Investigative Site 21042, Passo Fundo, Rio Grande do Sul, 99010 080, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Porto Alegre, Rio Grande do Sul Investigative Site 21025, Porto Alegre, Rio Grande do Sul, 90630-165, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Sergipe

Aracaju, Sergipe Investigative Site 21058, Aracaju, Sergipe, 409055-000, Brazil
Marc Bonaca, Contact, 3038609900, [email protected]
Recruiting
Aracaju, Sergipe Investigative Site 21015, Aracaju, Sergipe, 49055-530, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

São Paulo

Atibaia, São Paulo Investigative Site 21057, Atibaia, São Paulo, 12944-060, Brazil
Marc Bonaca, Contact, 3038609900, [email protected]
Recruiting
Santo André, Sao Paulo Investigative Site 21043, Santo André, São Paulo, 09090790, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Not yet recruiting
São José Dos Campos, Sao Paulo Investigative Site 21012, São José dos Campos, São Paulo, 12230-001, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
São Paulo, São Paulo Investigative Site 21062, São Paulo, São Paulo, 01317002, Brazil
Marc Bonaca, Contact, 3038609900, [email protected]
Recruiting
São Paulo, São Paulo Investigative Site 21048, São Paulo, São Paulo, 04004-30, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
São Paulo, São Paulo Investigative Site 21041, São Paulo, São Paulo, 04550-000, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
São Paulo, São Paulo Investigative Site 21035, São Paulo, São Paulo, 04696040, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
São Paulo, São Paulo Investigative Site 21049, São Paulo, São Paulo, 05652900, Brazil
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Alberta

Edmonton, AB Investigative Site 11018, Edmonton, Alberta, T5H 3V9, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Edmonton, Alberta Investigative Site 11011, Edmonton, Alberta, T6G 2B7, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

British Columbia

Kamloops, BC Investigative Site 11021, Kamloops, British Columbia, V2C 2T1, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
North Vancouver, BC Investigative Site11020, North Vancouver, British Columbia, V7M2H4, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Not yet recruiting
Surrey, British Columbia Investigative Site 11012, Surrey, British Columbia, V3V 0C6, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Vancouver, BC Investigative Site 11017, Vancouver, British Columbia, V6E 1M7, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Ontario

Cambridge, ON Investigative Site 11003, Cambridge, Ontario, N1R6V6, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Sudbury, ON Investigative Site 11016, Greater Sudbury, Ontario, P3E 5J1, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
North York, Ontario Investigative Site 11007, North York, Ontario, M6B3H7, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Toronto, Ontario Investigative Site 11008, Toronto, Ontario, M4N3M5, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Contact, [email protected]
Recruiting
Toronto, ON Investigative Site 11019, Toronto, Ontario, M5B 1W8, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Saskatchewan

Regina, SK Investigative Site 11022, Regina, Saskatchewan, S4P 0W5, Canada
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Croatia

Zagreb, Grad Zagreb Investigative Site 30005, Zagreb, Croatia, 10000, Croatia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Czech Republic

Chlumec nad Cidlinou, Czech Republic Investigative Site 31005, Chlumec nad Cidlinou, Czech Republic, 30100, Czechia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting
Plzeň, Czech Republic Investigative Site 31006, Pilsen, Czech Republic, 30100, Czechia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

State of Berlin

Berlin, Berlin Investigative Site 32001, Berlin, State of Berlin, 13353, Germany
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Greece

Athens, Investigative Site 33007, Athens, Greece, 14233, Greece
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Gujarat

Ahmedabad, Gujarat Investigative Site 51006, Ahmedabad, Gujarat, 380005, India
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Tamil Nadu

Chennai, Tamil Nadu Investigative site 51008, Chennai, Tamil Nadu, 600 006, India
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Varese

Varese, Varese Investigative Site 35004, Varese, Varese, 21100, Italy
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Lithuania

Alytus, Lithuania Investigative Site 36005, Alytus, Lithuania, LT-62114, Lithuania
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Kedah

Alor Setar, Kedah Investigative Site 52006, Alor Star, Kedah, 05460, Malaysia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Kuala Lumpur

Kuala Lumpur, Wilayah Persekutuan Investigative Site 52007, Kuala Lumpur, Kuala Lumpur, 50400, Malaysia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Pahang

Kuantan, Pahang Investigative Site 52004, Kuantan, Pahang, 25100, Malaysia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Selangor

Kajang, Selangor Investigative Site 52008, Kajang, Selangor, 43000, Malaysia
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Flores

CULIACÁN, Flores Investigative Site 23002, Culiacán, Flores, 80230, Mexico
Marc Bonaca, Contact, 303-860-9900, [email protected]
Not yet recruiting

Michoacán

Morelia, Michoacan Investigative Site 23007, Morelia, Michoacán, 58260, Mexico
Marc Bonaca, Contact, 303-860-9900, [email protected]
Not yet recruiting

Sinaloa

Culiacan, Sinaloa Investigative Site 23006, Culiacán, Sinaloa, 80020, Mexico
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Lima Province

Lima, Lima Investigative Site 24011, Lima, Lima Province, 15046, Peru
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Seoul

Seodaemun-gu, Seoul Investigative Site 53001, Seoul, Seoul, 03722, South Korea
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Galicia

Santiago De Compostela, Galicia Investigative Site 38008, Santiago de Compostela, Galicia, 15706, Spain
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Spain

Barcelona, Spain Investigative Site 38010, Barcelona, Spain, 08907, Spain
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting

Taiwan

Taipei, Taiwan Investigative Site 55008, Taipei, Taiwan, 106, Taiwan
Marc Bonaca, Contact, 303-860-9900, [email protected]
Recruiting