A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
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
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares finerenone with a placebo, a treatment with no active drug, to see how safe it is and whether it reduces illness and death. It is for adults in the hospital or recently sent home after worsening heart failure whose heart pumping strength is mildly reduced or preserved.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a form agreeing to join the study.
- Be at least 18, or the legal adult age in your country if it is higher.
- Be in the hospital mainly for heart failure, or have left the hospital within the past 30 days.
- Have had signs and symptoms of heart failure when admitted to the hospital.
- Have a heart scan showing an ejection fraction of at least 40%. This is the share of blood the heart's main pumping chamber pushes out with each beat.
- Have high blood levels of markers linked to heart failure: NTproBNP at least 500 pg/mL or BNP at least 125 pg/mL. If you have atrial fibrillation, an irregular heartbeat, the levels must be at least 1500 or 375 pg/mL, respectively.
Who can't join
- Take, or plan to take long term, an MRA, a drug that blocks the hormone aldosterone; or have had severely high blood potassium while taking one.
- Have an eGFR below 25, a test result showing very low kidney function, or blood potassium above 5.0 mmol/L at screening.
- Within the past 30 days, have had a heart attack caused by plaque breaking open in an artery, a procedure to restore heart blood flow, heart valve repair or replacement, or a device placed to help the heart's chambers beat together.
- Have severe, untreated heart valve disease that affects blood flow.
- Have certain heart muscle diseases caused by sudden inflammation, substances building up in the heart, muscular dystrophy, or a cause that can be reversed. Other excluded conditions include thick heart muscle that blocks blood flow, complex heart defects present at birth, or a stiff sac around the heart.
- Have another likely cause for your heart failure symptoms.
- Take certain medicines that strongly block or moderately or strongly boost CYP3A4, a protein that helps the body break down drugs.
- Have a known allergy to the study drug or any of its ingredients.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 sites (82)
AL
- Birmingham, AL Investigative Site 10012 · Birmingham, AL 35205Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Birmingham
- Fairhope, AL Investigative Site 10004 · Fairhope, AL 36532Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Fairhope
- Huntsville, AL Investigative Site 10026 · Huntsville, AL 35801Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Huntsville
AZ
- Glendale, AZ Investigative Site 10096 · Glendale, AZ 85304Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Glendale
- Phoenix, AZ Investigative Site 10115 · Phoenix, AZ 85006Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Phoenix
- Scottsdale, AZ Investigative Site 10003 · Scottsdale, AZ 85258Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Scottsdale
CA
- Chula Vista, CA Investigative Site 10111 · Chula Vista, CA 91911Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Chula Vista
- Huntington Beach, CA Investigative Site 10031 · Huntington Beach, CA 92648Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Huntington Beach
- Los Angeles, CA Investigative Site 10089 · Los Angeles, CA 90073Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Los Angeles
- Sacramento, CA Investigative Site 10024 · Sacramento, CA 95816Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Sacramento
- San Francisco, CA Investigative Site 10023 · San Francisco, CA 94118Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in San Francisco
- Tarzana, CA Investigative Site 10409 · Tarzana, CA 91356Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Tarzana
- Van Nuys, CA Investigative Site 10109 · Van Nuys, CA 91405Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Van Nuys
- West Hills, CA Investigative Site 10013 · West Hills, CA 91307Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in West Hills
CO
- Aurora, CO Investigative Site 10001 · Aurora, CO 80045Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Aurora
- Denver, CO Investigative Site 10005 · Denver, CO 80204Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Denver
FL
- Bradenton, FL Investigative Site 10125 · Bradenton, FL 34209Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Bradenton
- Brooksville, FL Investigative Site 10077 · Brooksville, FL 34613Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Brooksville
- Fort Lauderdale, FL Investigative Site 10114 · Fort Lauderdale, FL 33308Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Fort Lauderdale
- Fort Myers, FL Investigative Site 10076 · Fort Myers, FL 33919Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Fort Myers
- Hialeah, FL Investigative Site 10104 · Hialeah, FL 33012Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Hialeah
- Jacksonville, FL Investigative Site 10028 · Jacksonville, FL 32209Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Jacksonville
- Miami, FL Investigative Site 10105 · Miami, FL 33135Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Miami
- Miami, FL Investigative Site 10040 · Miami, FL 33173Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Miami
- Miramar, FL Investigative Site 10113 · Miramar, FL 33027Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Miramar
- Tamarac, Florida Investigative Site 10127 · Tamarac, FL 33321Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Tamarac
GA
- Atlanta, GA Investigative Site 10022 · Atlanta, GA 30303Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Atlanta
- Duluth, GA Investigative Site 10083 · Duluth, GA 30096Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Duluth
ID
- Boise, Idaho Investigative Site 10073 · Boise, ID 83712Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Boise
IL
- Chicago, IL Investigative Site 10062 · Chicago, IL 60612Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Chicago
- Glenview, IL Investigative Site 10021 · Glenview, IL 60026Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Glenview
- Naperville, IL Investigative Site 10025 · Naperville, IL 60540Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Naperville
- Peoria, IL Investigative Site 10019 · Peoria, IL 61603Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Peoria
- Peoria, IL Investigative Site 10010 · Peoria, IL 61614Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Peoria
IN
- Indianapolis, IN Investigative Site 10074 · Indianapolis, IN 46237Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Indianapolis
- Indianapolis, IN Investigative Site 10008 · Indianapolis, IN 46260Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Indianapolis
- Merrillville, IN Investigative Site 10064 · Merrillville, IN 46410Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Merrillville
KS
- Kansas City, KS Investigative Site 10060 · Kansas City, KS 66103Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Kansas City
KY
- Cynthiana, KY Investigative Site 10124 · Cynthiana, KY 41031Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Cynthiana
- Lexington, KY Investigative Site 10080 · Lexington, KY 40503Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Lexington
- Lexington, KY Investigative Site 10118 · Lexington, KY 40536Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Lexington
- Louisville, KY Investigative Site 10006 · Louisville, KY 40202Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Louisville
- Louisville, KY Investigative Site 10086 · Louisville, KY 40205Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Louisville
- Paducah, KY Investigative Site 10079 · Paducah, KY 42003Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Paducah
LA
- Baton Rouge, LA Investigative Site 10030 · Baton Rouge, LA 70808Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Baton Rouge
- Hammond, LA Investigative Site 10106 · Hammond, LA 70403Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Hammond
- West Monroe, LA Investigative Site 10090 · West Monroe, LA 71291Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in West Monroe
MA
- Boston, MA Investigative Stie 10087 · Boston, MA 02114Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Boston
MD
- Baltimore, MD Investigative Site 10101 · Baltimore, MD 21287Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Baltimore
- Bowie, MD Investigative Site 10020 · Bowie, MD 20715Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Bowie
MN
- Minneapolis, MN Investigative Site 10091 · Minneapolis, MN 55407-1139Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Minneapolis
- Minneapolis, MN Investigative Site 10035 · Minneapolis, MN 55417Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Minneapolis
MO
- Kansas City, MO Investigative Site 10002 · Kansas City, MO 64111Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Kansas City
MS
- Tupelo, MS Investigative Site 10100 · Tupelo, MS 38801Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Tupelo
NC
- Greenville, NC Investigative Site 10122 · Greenville, NC 27834Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Greenville
NE
- Omaha, NE Investigative Site 10018 · Omaha, NE 68105Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Omaha
NJ
- Camden, NJ Investigative Site 10033 · Camden, NJ 08103Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Camden
NY
- Roslyn, NY Investigative Site 10058 · Roslyn, NY 11576Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Roslyn
- Stony Brook, NY Investigative Site 10017 · Stony Brook, NY 11794-8171Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Stony Brook
OH
- Akron, OH Investigative Site 10081 · Akron, OH 44304Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Akron
- Centerville, OH Investigative Site 10119 · Centerville, OH 45459Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Centerville
- Cincinnati, OH Investigative Site 10088 · Cincinnati, OH 45220Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Cincinnati
OK
- Bartlesville, OK Investigative Site 10095 · Bartlesville, OK 74006Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Bartlesville
PA
- Philadelphia, PA Investigative Site 10068 · Philadelphia, PA 19107Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Philadelphia
- Pittsburg, PA Investigative Site 1044 · Pittsburgh, PA 15212Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Pittsburgh
RI
- Providence, RI Investigative Site 10050 · Providence, RI 02908Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Providence
SC
- Charleston, SC Investigative Site 10056 · Charleston, SC 29425Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Charleston
TN
- Germantown, TN Investigative Site 10063 · Germantown, TN 38138Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Germantown
- Memphis, TN Investigative Site 10059 · Memphis, TN 38105Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Memphis
- Nashville, TN Investigative Site 10071 · Nashville, TN 37203Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Nashville
TX
- Amarillo, TX Investigative Site 10045 · Amarillo, TX 79106Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Amarillo
- Austin, TX Investigative Site 10015 · Austin, TX 78705Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Austin
- Dallas, TX Investigative Site 10042 · Dallas, TX 75216Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Dallas
- Houston, TX Investigative Site 10085 · Houston, TX 77030Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Houston
- Plano, TX Investigative Site 10014 · Plano, TX 75093Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Plano
VA
- Norfolk, VA Investigative Site 10009 · Norfolk, VA 23507Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Norfolk
- Richmond, VA Investigative Site 10069 · Richmond, VA 23225Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Richmond
- Richmond, VA Investigative Site 10067 · Richmond, VA 23249Marc Bonaca, MD · Study contact · +1-303-860-9900More trials in Richmond
- Salem, VA Investigative Site 10048 · Salem, VA 24153Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Salem
VT
- Burlington, VT Investigative Site 10053 · Burlington, VT 05401Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Burlington
WA
- Spokane, WA Investigative Site 10123 · Spokane, WA 99204Marc Bonaca, MD · Study contact · +1-303-860-9900 · info@cpcmed.orgMore trials in Spokane
WI
- Milwaukee, WI Investigative Site 10061 · Milwaukee, WI 53226Marc Bonaca · Study contact · 303-860-9900 · info@cpcmed.orgMore trials in Milwaukee