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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

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.

AlabamaBirmingham, AL Investigative Site 10012, Birmingham
Fairhope, AL Investigative Site 10004, Fairhope
Huntsville, AL Investigative Site 10026, Huntsville
ArizonaGlendale, AZ Investigative Site 10096, Glendale
Phoenix, AZ Investigative Site 10115, Phoenix
Scottsdale, AZ Investigative Site 10003, Scottsdale
CaliforniaChula 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
ColoradoAurora, CO Investigative Site 10001, Aurora
Denver, CO Investigative Site 10005, Denver
FloridaBradenton, 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
GeorgiaAtlanta, GA Investigative Site 10022, Atlanta
Duluth, GA Investigative Site 10083, Duluth
IdahoBoise, Idaho Investigative Site 10073, Boise
IllinoisChicago, 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
IndianaIndianapolis, IN Investigative Site 10008, Indianapolis
Indianapolis, IN Investigative Site 10074, Indianapolis
Merrillville, IN Investigative Site 10064, Merrillville
KansasKansas City, KS Investigative Site 10060, Kansas City
KentuckyCynthiana, 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
LouisianaBaton Rouge, LA Investigative Site 10030, Baton Rouge
Hammond, LA Investigative Site 10106, Hammond
West Monroe, LA Investigative Site 10090, West Monroe
MarylandBaltimore, MD Investigative Site 10101, Baltimore
Bowie, MD Investigative Site 10020, Bowie
MassachusettsBoston, MA Investigative Stie 10087, Boston
MinnesotaMinneapolis, MN Investigative Site 10035, Minneapolis
Minneapolis, MN Investigative Site 10091, Minneapolis
MississippiTupelo, MS Investigative Site 10100, Tupelo (Not yet recruiting)
MissouriKansas City, MO Investigative Site 10002, Kansas City
NebraskaOmaha, NE Investigative Site 10018, Omaha
New JerseyCamden, NJ Investigative Site 10033, Camden
New YorkRoslyn, NY Investigative Site 10058, Roslyn
Stony Brook, NY Investigative Site 10017, Stony Brook
North CarolinaGreenville, NC Investigative Site 10122, Greenville
OhioAkron, OH Investigative Site 10081, Akron
Centerville, OH Investigative Site 10119, Centerville
Cincinnati, OH Investigative Site 10088, Cincinnati
OklahomaBartlesville, OK Investigative Site 10095, Bartlesville
PennsylvaniaPhiladelphia, PA Investigative Site 10068, Philadelphia
Pittsburg, PA Investigative Site 1044, Pittsburgh
Rhode IslandProvidence, RI Investigative Site 10050, Providence
South CarolinaCharleston, SC Investigative Site 10056, Charleston
TennesseeGermantown, TN Investigative Site 10063, Germantown
Memphis, TN Investigative Site 10059, Memphis
Nashville, TN Investigative Site 10071, Nashville
TexasAmarillo, 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
VermontBurlington, VT Investigative Site 10053, Burlington
VirginiaNorfolk, VA Investigative Site 10009, Norfolk
Richmond, VA Investigative Site 10067, Richmond
Richmond, VA Investigative Site 10069, Richmond
Salem, VA Investigative Site 10048, Salem
WashingtonSpokane, WA Investigative Site 10123, Spokane
WisconsinMilwaukee, 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.