NCT06008197 · Colorado Prevention Center
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
(REDEFINE-HF)
What this study is about
Finerenone will be compared to placebo to determine effectiveness and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
View original scientific description
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.
Interventions
DRUG
Finerenone
Oral finerenone
DRUG
Placebo
Matching oral placebo
Primary outcome measures
Composite of total HF events and cardiovascular (CV) death.
Time frame: Ongoing, up to ~30 months
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
Number of serious adverse events.
Time frame: Ongoing, up to ~30 months
Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.
Time frame: Ongoing, up to ~30 months
Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provide electronic or written informed consent, either personally or through a legally authorized representative
- Age ≥18 years
- Current hospitalization or recently discharged 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) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF
Exclusion criteria
- 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 serum/plasma potassium \>5.0 mmol/L at screening
- Acute myocardial infarction, coronary revascularization, v
Where
- Birmingham, Alabama
- Fairhope, Alabama
- Huntsville, Alabama
- Glendale, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Chula Vista, California
- Huntington Beach, California
- Los Angeles, California
- Sacramento, California
- San Francisco, California
- Tarzana, California
And 61 more locations — see the full list below.
Collaborators
St. Luke's Hospital, Kansas City, Missouri, Bayer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations