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A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
RecruitingPhase 3
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)
Who can join
Ages 18 and older · All sexes
Full 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)
About the study
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.
What is being tested
- Finerenone (drug)
- Placebo (drug)
Sponsor: Colorado Prevention Center · Participants: 5,200 · Started: Jan 17, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06008197
Locations in the U.S.
| Alabama | Birmingham, AL Investigative Site 10012, Birmingham Fairhope, AL Investigative Site 10004, Fairhope Huntsville, AL Investigative Site 10026, Huntsville |
| Arizona | Glendale, AZ Investigative Site 10096, Glendale Phoenix, AZ Investigative Site 10115, Phoenix Scottsdale, AZ Investigative Site 10003, Scottsdale |
| California | Chula Vista, CA Investigative Site 10111, Chula Vista Huntington Beach, CA Investigative Site 10031, Huntington Beach Los Angeles, CA Investigative Site 10089, Los Angeles Sacramento, CA Investigative Site 10024, Sacramento San Francisco, CA Investigative Site 10023, San Francisco Tarzana, CA Investigative Site 10409, Tarzana Van Nuys, CA Investigative Site 10109, Van Nuys West Hills, CA Investigative Site 10013, West Hills |
| Colorado | Aurora, CO Investigative Site 10001, Aurora Denver, CO Investigative Site 10005, Denver |
| Florida | Bradenton, FL Investigative Site 10125, Bradenton Brooksville, FL Investigative Site 10077, Brooksville Fort Lauderdale, FL Investigative Site 10114, Fort Lauderdale Fort Myers, FL Investigative Site 10076, Fort Myers Hialeah, FL Investigative Site 10104, Hialeah Jacksonville, FL Investigative Site 10028, Jacksonville Miami, FL Investigative Site 10040, Miami Miami, FL Investigative Site 10105, Miami Miramar, FL Investigative Site 10113, Miramar (Not yet recruiting) Tamarac, Florida Investigative Site 10127, Tamarac |
| Georgia | Atlanta, GA Investigative Site 10022, Atlanta Duluth, GA Investigative Site 10083, Duluth |
| Idaho | Boise, Idaho Investigative Site 10073, Boise |
| Illinois | Chicago, IL Investigative Site 10062, Chicago Glenview, IL Investigative Site 10021, Glenview Naperville, IL Investigative Site 10025, Naperville Peoria, IL Investigative Site 10010, Peoria Peoria, IL Investigative Site 10019, Peoria |
| Indiana | Indianapolis, IN Investigative Site 10008, Indianapolis Indianapolis, IN Investigative Site 10074, Indianapolis Merrillville, IN Investigative Site 10064, Merrillville |
| Kansas | Kansas City, KS Investigative Site 10060, Kansas City |
| Kentucky | Cynthiana, KY Investigative Site 10124, Cynthiana Lexington, KY Investigative Site 10080, Lexington Lexington, KY Investigative Site 10118, Lexington Louisville, KY Investigative Site 10006, Louisville Louisville, KY Investigative Site 10086, Louisville (Not yet recruiting) Paducah, KY Investigative Site 10079, Paducah |
| Louisiana | Baton Rouge, LA Investigative Site 10030, Baton Rouge Hammond, LA Investigative Site 10106, Hammond West Monroe, LA Investigative Site 10090, West Monroe |
| Maryland | Baltimore, MD Investigative Site 10101, Baltimore Bowie, MD Investigative Site 10020, Bowie |
| Massachusetts | Boston, MA Investigative Stie 10087, Boston |
| Minnesota | Minneapolis, MN Investigative Site 10035, Minneapolis Minneapolis, MN Investigative Site 10091, Minneapolis |
| Mississippi | Tupelo, MS Investigative Site 10100, Tupelo (Not yet recruiting) |
| Missouri | Kansas City, MO Investigative Site 10002, Kansas City |
| Nebraska | Omaha, NE Investigative Site 10018, Omaha |
| New Jersey | Camden, NJ Investigative Site 10033, Camden |
| New York | Roslyn, NY Investigative Site 10058, Roslyn Stony Brook, NY Investigative Site 10017, Stony Brook |
| North Carolina | Greenville, NC Investigative Site 10122, Greenville |
| Ohio | Akron, OH Investigative Site 10081, Akron Centerville, OH Investigative Site 10119, Centerville Cincinnati, OH Investigative Site 10088, Cincinnati |
| Oklahoma | Bartlesville, OK Investigative Site 10095, Bartlesville |
| Pennsylvania | Philadelphia, PA Investigative Site 10068, Philadelphia Pittsburg, PA Investigative Site 1044, Pittsburgh |
| Rhode Island | Providence, RI Investigative Site 10050, Providence |
| South Carolina | Charleston, SC Investigative Site 10056, Charleston |
| Tennessee | Germantown, TN Investigative Site 10063, Germantown Memphis, TN Investigative Site 10059, Memphis Nashville, TN Investigative Site 10071, Nashville |
| Texas | Amarillo, TX Investigative Site 10045, Amarillo Austin, TX Investigative Site 10015, Austin Dallas, TX Investigative Site 10042, Dallas Houston, TX Investigative Site 10085, Houston Plano, TX Investigative Site 10014, Plano |
| Vermont | Burlington, VT Investigative Site 10053, Burlington |
| Virginia | Norfolk, VA Investigative Site 10009, Norfolk Richmond, VA Investigative Site 10067, Richmond Richmond, VA Investigative Site 10069, Richmond Salem, VA Investigative Site 10048, Salem |
| Washington | Spokane, WA Investigative Site 10123, Spokane |
| Wisconsin | Milwaukee, WI Investigative Site 10061, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.