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Finerenone for Hospitalized Heart Failure Patients

This study is looking at whether finerenone can help patients who are in the hospital, or were recently discharged, because of heart failure. Heart failure means your heart isn't pumping blood as well as it should. Researchers want to see if finerenone is effective and safe compared to a placebo (an inactive pill) for people with heart failure where their heart's pumping ability is mildly reduced or preserved. You might be able to join if you are 18 or older, have heart failure symptoms, and have imaging proof of your heart's pumping ability. The study will measure how often heart failure events happen and if people pass away from heart problems, as well as any side effects. This study is currently recruiting about 5200 participants.

Study design
This is an international, randomized, double-blind study, meaning participants are randomly assigned to receive either finerenone or a placebo, and neither you nor your doctor will know which you are receiving. It plans to enroll 5200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 30 months to measure heart failure events, cardiovascular death, and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06008197

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Colorado Prevention Center
~5,200 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:FinerenonePlacebo

At a glance

Recruiting sites
307 of 315 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of total HF events and cardiovascular (CV) death.
Measured over Ongoing, up to ~30 months
+2 more outcomes measured

Conditions

Heart Failure
Acute Heart Failure

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Where it's being run

315 sites across 143 states
São Paulo19
Florida9
Western Province9
California8
Hungary8
Spain8
United Kingdom8
Ontario7

Who to contact

Marc Bonaca
[email protected]
303-860-9900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Composite of total HF events and cardiovascular (CV) death.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.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.Ongoing, up to ~30 months

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