ClinicalTrials.gg
RecruitingNCT06008197REDEFINE-HFUpdated Sep 10, 2026

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

A Phase 3 interventional study of Finerenone and Placebo in Heart Failure and Acute Heart Failure, sponsored by Colorado Prevention Center. Recruiting at 356 sites in 26 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Colorado Prevention Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
5,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure
  • Acute Heart Failure

Browse trials for

Keywords

  • Heart failure
  • Preserved ejection fraction
  • Mildly reduced ejection fraction
  • Hospitalized
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 5,200 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Colorado Prevention Center is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provide written
  • 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 (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

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 (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 () inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
  • Known to the IP (active substance or )
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
5,200 participants (estimated)

Study arms

  • Experimental
    Finerenone

    Drug: Finerenone

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • Oral finerenone

    Also known as: Kerendia, Firialta

  • DrugPlacebo

    Matching oral placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Ongoing, up to ~30 months

  2. Number of serious adverse events.

    Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.

    Time frame: Ongoing, up to ~30 months

  3. Number of adverse events leading to discontinuation of study drug.

    Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.

    Time frame: Ongoing, up to ~30 months

Secondary outcomes

  1. 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.

    Time frame: Ongoing, up to ~30 months

  2. Total HF events.

    Total HF events with finerenone compared to placebo.

    Time frame: Ongoing, up to ~30 months

  3. Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.

    Time frame: 6 Months

  4. Time to CV death.

    Time to CV death with finerenone compared to placebo.

    Time frame: Ongoing, up to ~30 months

  5. Time to death from any cause.

    Time to death from any cause with finerenone compared to placebo.

    Time frame: Ongoing, up to ~30 months

07

Study locations

348 of 356 sites recruiting
  • Birmingham, AL Investigative Site 10012
    Birmingham, Alabama 35205, United States
    Recruiting
  • Fairhope, AL Investigative Site 10004
    Fairhope, Alabama 36532, United States
    Recruiting
  • Huntsville, AL Investigative Site 10026
    Huntsville, Alabama 35801, United States
    Recruiting
  • Glendale, AZ Investigative Site 10096
    Glendale, Arizona 85304, United States
    Recruiting
  • Phoenix, AZ Investigative Site 10115
    Phoenix, Arizona 85006, United States
    Recruiting
  • Scottsdale, AZ Investigative Site 10003
    Scottsdale, Arizona 85258, United States
    Recruiting
  • Chula Vista, CA Investigative Site 10111
    Chula Vista, California 91911, United States
    Recruiting
  • Huntington Beach, CA Investigative Site 10031
    Huntington Beach, California 92648, United States
    Recruiting
  • Los Angeles, CA Investigative Site 10089
    Los Angeles, California 90073, United States
    Recruiting
  • Sacramento, CA Investigative Site 10024
    Sacramento, California 95816, United States
    Recruiting
  • San Francisco, CA Investigative Site 10023
    San Francisco, California 94118, United States
    Recruiting
  • Tarzana, CA Investigative Site 10409
    Tarzana, California 91356, United States
    Recruiting
  • Van Nuys, CA Investigative Site 10109
    Van Nuys, California 91405, United States
    Recruiting
  • West Hills, CA Investigative Site 10013
    West Hills, California 91307, United States
    Recruiting
  • Aurora, CO Investigative Site 10001
    Aurora, Colorado 80045, United States
    Recruiting
  • Denver, CO Investigative Site 10005
    Denver, Colorado 80204, United States
    Recruiting
  • Bradenton, FL Investigative Site 10125
    Bradenton, Florida 34209, United States
    Recruiting
  • Brooksville, FL Investigative Site 10077
    Brooksville, Florida 34613, United States
    Recruiting
  • Fort Lauderdale, FL Investigative Site 10114
    Fort Lauderdale, Florida 33308, United States
    Recruiting
  • Fort Myers, FL Investigative Site 10076
    Fort Myers, Florida 33919, United States
    Recruiting
  • Hialeah, FL Investigative Site 10104
    Hialeah, Florida 33012, United States
    Recruiting
  • Jacksonville, FL Investigative Site 10028
    Jacksonville, Florida 32209, United States
    Recruiting
  • Miami, FL Investigative Site 10105
    Miami, Florida 33135, United States
    Recruiting
  • Miami, FL Investigative Site 10040
    Miami, Florida 33173, United States
    Recruiting
  • Miramar, FL Investigative Site 10113
    Miramar, Florida 33027, United States
    Not yet recruiting
  • Tamarac, Florida Investigative Site 10127
    Tamarac, Florida 33321, United States
    Recruiting
  • Atlanta, GA Investigative Site 10022
    Atlanta, Georgia 30303, United States
    Recruiting
  • Duluth, GA Investigative Site 10083
    Duluth, Georgia 30096, United States
    Recruiting
  • Boise, Idaho Investigative Site 10073
    Boise, Idaho 83712, United States
    Recruiting
  • Chicago, IL Investigative Site 10062
    Chicago, Illinois 60612, United States
    Recruiting
  • Glenview, IL Investigative Site 10021
    Glenview, Illinois 60026, United States
    Recruiting
  • Naperville, IL Investigative Site 10025
    Naperville, Illinois 60540, United States
    Recruiting
  • Peoria, IL Investigative Site 10019
    Peoria, Illinois 61603, United States
    Recruiting
  • Peoria, IL Investigative Site 10010
    Peoria, Illinois 61614, United States
    Recruiting
  • Indianapolis, IN Investigative Site 10074
    Indianapolis, Indiana 46237, United States
    Recruiting
  • Indianapolis, IN Investigative Site 10008
    Indianapolis, Indiana 46260, United States
    Recruiting
  • Merrillville, IN Investigative Site 10064
    Merrillville, Indiana 46410, United States
    Recruiting
  • Kansas City, KS Investigative Site 10060
    Kansas City, Kansas 66103, United States
    Recruiting
  • Cynthiana, KY Investigative Site 10124
    Cynthiana, Kentucky 41031, United States
    Recruiting
  • Lexington, KY Investigative Site 10080
    Lexington, Kentucky 40503, United States
    Recruiting
  • Lexington, KY Investigative Site 10118
    Lexington, Kentucky 40536, United States
    Recruiting
  • Louisville, KY Investigative Site 10006
    Louisville, Kentucky 40202, United States
    Recruiting
  • Louisville, KY Investigative Site 10086
    Louisville, Kentucky 40205, United States
    Not yet recruiting
  • Paducah, KY Investigative Site 10079
    Paducah, Kentucky 42003, United States
    Recruiting
  • Baton Rouge, LA Investigative Site 10030
    Baton Rouge, Louisiana 70808, United States
    Recruiting
  • Hammond, LA Investigative Site 10106
    Hammond, Louisiana 70403, United States
    Recruiting
  • West Monroe, LA Investigative Site 10090
    West Monroe, Louisiana 71291, United States
    Recruiting
  • Baltimore, MD Investigative Site 10101
    Baltimore, Maryland 21287, United States
    Recruiting
  • Bowie, MD Investigative Site 10020
    Bowie, Maryland 20715, United States
    Recruiting
  • Boston, MA Investigative Stie 10087
    Boston, Massachusetts 02114, United States
    Recruiting
  • Minneapolis, MN Investigative Site 10091
    Minneapolis, Minnesota 55407-1139, United States
    Recruiting
  • Minneapolis, MN Investigative Site 10035
    Minneapolis, Minnesota 55417, United States
    Recruiting
  • Tupelo, MS Investigative Site 10100
    Tupelo, Mississippi 38801, United States
    Not yet recruiting
  • Kansas City, MO Investigative Site 10002
    Kansas City, Missouri 64111, United States
    Recruiting
  • Omaha, NE Investigative Site 10018
    Omaha, Nebraska 68105, United States
    Recruiting
  • Camden, NJ Investigative Site 10033
    Camden, New Jersey 08103, United States
    Recruiting
  • Roslyn, NY Investigative Site 10058
    Roslyn, New York 11576, United States
    Recruiting
  • Stony Brook, NY Investigative Site 10017
    Stony Brook, New York 11794-8171, United States
    Recruiting
  • Greenville, NC Investigative Site 10122
    Greenville, North Carolina 27834, United States
    Recruiting
  • Akron, OH Investigative Site 10081
    Akron, Ohio 44304, United States
    Recruiting
  • Centerville, OH Investigative Site 10119
    Centerville, Ohio 45459, United States
    Recruiting
  • Cincinnati, OH Investigative Site 10088
    Cincinnati, Ohio 45220, United States
    Recruiting
  • Bartlesville, OK Investigative Site 10095
    Bartlesville, Oklahoma 74006, United States
    Recruiting
  • Philadelphia, PA Investigative Site 10068
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
  • Pittsburg, PA Investigative Site 1044
    Pittsburgh, Pennsylvania 15212, United States
    Recruiting
  • Providence, RI Investigative Site 10050
    Providence, Rhode Island 02908, United States
    Recruiting
  • Charleston, SC Investigative Site 10056
    Charleston, South Carolina 29425, United States
    Recruiting
  • Germantown, TN Investigative Site 10063
    Germantown, Tennessee 38138, United States
    Recruiting
  • Memphis, TN Investigative Site 10059
    Memphis, Tennessee 38105, United States
    Recruiting
  • Nashville, TN Investigative Site 10071
    Nashville, Tennessee 37203, United States
    Recruiting
  • Amarillo, TX Investigative Site 10045
    Amarillo, Texas 79106, United States
    Recruiting
  • Austin, TX Investigative Site 10015
    Austin, Texas 78705, United States
    Recruiting
  • Dallas, TX Investigative Site 10042
    Dallas, Texas 75216, United States
    Recruiting
  • Houston, TX Investigative Site 10085
    Houston, Texas 77030, United States
    Recruiting
  • Plano, TX Investigative Site 10014
    Plano, Texas 75093, United States
    Recruiting
  • Burlington, VT Investigative Site 10053
    Burlington, Vermont 05401, United States
    Recruiting
  • Norfolk, VA Investigative Site 10009
    Norfolk, Virginia 23507, United States
    Recruiting
  • Richmond, VA Investigative Site 10069
    Richmond, Virginia 23225, United States
    Recruiting
  • Richmond, VA Investigative Site 10067
    Richmond, Virginia 23249, United States
    Recruiting
    • Marc Bonaca, MD · Contact+1-303-860-9900
  • Salem, VA Investigative Site 10048
    Salem, Virginia 24153, United States
    Recruiting
  • Spokane, WA Investigative Site 10123
    Spokane, Washington 99204, United States
    Recruiting
  • Milwaukee, WI Investigative Site 10061
    Milwaukee, Wisconsin 53226, United States
    Recruiting
  • Buenos Aires Investigative Site 20017
    Buenos Aires, Buenos Aires 1180, Argentina
    Recruiting
  • Buenos Aires Investigative Site 20009
    Buenos Aires, Buenos Aires C1437JC, Argentina
    Recruiting
  • La Plata, Buenos Aires Investigative Site 20023
    La Plata, Buenos Aires 1904, Argentina
    Recruiting
  • Lanús, Buenos Aires Investigative Site 20024
    Lanus, Buenos Aires 1824, Argentina
    Recruiting
  • Corrientes Investigative Site 20001
    Corrientes, Corrientes Province W3400AMZ, Argentina
    Recruiting
  • Córdoba Investigative Site 20025
    Córdoba, Córdoba Province 5000, Argentina
    Recruiting
  • Córdoba Investigative Site 20012
    Córdoba, Córdoba Province 5002, Argentina
    Recruiting
  • Córdoba Investigative Site 20013
    Córdoba, Córdoba Province 5003, Argentina
    Recruiting
  • Córdoba Investigative Site 20016
    Córdoba, Córdoba Province 5003, Argentina
    Recruiting
  • Córdoba, Córdoba Investigative Site 20014
    Córdoba, Córdoba Province 5003, Argentina
    Recruiting
  • Salta Investigative Site 20006
    Salta, Salta Province 4400, Argentina
    Recruiting
  • San Juan, San Juan Investigative Site 20021
    San Juan, San Juan Province 5400, Argentina
    Recruiting
  • San Juan, San Juan Investigative Site 20020
    San Juan, San Juan Province J5402, Argentina
    Recruiting
  • Rafaela, Santa Fe Investigative Site 20026
    Rafaela, Santa Fe Province 2300, Argentina
    Recruiting
  • Rosario, Santa Fe Investigative Site 20003
    Rosario, Santa Fe Province 2000, Argentina
    Recruiting
  • Rosario, Santa Fe Investigative Site 20022
    Rosario, Santa Fe Province 2000, Argentina
    Recruiting
  • Rosario, Santa Fe Investigative Site 20027
    Rosario, Santa Fe Province 5000, Argentina
    Recruiting
  • Rosario, Santa Fe Investigative Site 20019
    Rosario, Santa Fe Province S2000CVD, Argentina
    Recruiting

Showing the first 100 of 356 sites across 26 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No — No current plan to share individual patient data with other researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06008197
Lead sponsor
Colorado Prevention Center
Collaborators
St. Luke's Hospital, Kansas City, Missouri, Bayer
Responsible party
Sponsor
First posted
Aug 23, 2023
Start date
Jan 17, 2024
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Marc Bonaca
Contact
info@cpcmed.org
303-860-9900

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Finerenone

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