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Finerenone and Empagliflozin for Heart Failure

This study, called CONFIRMATION-HF, is looking at whether a combination of two drugs, finerenone and empagliflozin, is effective and safe for people hospitalized with heart failure. Researchers will compare this combination treatment to the usual care you would receive. You might be able to join if you are 18 or older and are currently in the hospital or were recently discharged because of heart failure. The study will measure how well the treatment works and look at any serious side effects over 6 months. The current recruitment status is unclear.

Study design
This is an international, randomized, controlled, open-label study involving about 1500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes will be measured at 6 months.

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

NCT06024746

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Colorado Prevention Center
~1,500 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:FinerenoneEmpagliflozin

At a glance

Recruiting sites
140 of 140 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical benefit
Measured over 6 months
+2 more outcomes measured

Conditions

Heart Failure

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Heart Failure

NCT06024746

Where you'd take part

This study runs at 140 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A Coruña, Galicia Investigative Site CON-38004

    A Coruña, Galicia, Spainstudy coordinator listed

    Recruiting

  • Barcelona Investigative Site CON-38010

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • Belo Horizonte, Minas Gerais Investigative Site CON-21079

    Belo Horizonte, Minas Gerais, Brazilstudy coordinator listed

    Recruiting

  • Bradenton, FL Investigative Site CON-10125

    Bradenton, Floridastudy coordinator listed

    Recruiting

  • Campinas, São Paulo Investigative Site CON-21083

    Campinas, São Paulo, Brazilstudy coordinator listed

    Recruiting

  • Chula Vista, CA Investigative Site CON-10111

    Chula Vista, Californiastudy coordinator listed

    Recruiting

  • Colombo, Western Province, Investigative Site CON-54006

    Colombo, Western Province, Sri Lankastudy coordinator listed

    Recruiting

  • CON-10001, Aurora, CO

    Aurora, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

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

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Eligibility criteria

Inclusion

Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
Current hospitalization or recently discharged with the primary diagnosis of heart failure
Heart failure signs and symptoms at the time of hospital admission
Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Exclusion

Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
Documented prior history of severe hyperkalemia in the setting of MRA use
Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i
Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² and/or potassium \>5.0 mmol/L
Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
Prior or planned heart transplant
Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or 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)
Any other condition or therapy which would make the patient unsuitable for this study

What this trial measures

  • Clinical benefit6 months

    Hierarchical composite of the following: * Time to all-cause mortality * Number of total HF events * Time to first HF event * Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method

  • Number of serious adverse events (AEs).6 months

    \- Serious AEs (excluding efficacy endpoints).

  • Number of adverse events leading to discontinuation of study drug.6 months

    \- AEs leading to discontinuation of finerenone or empagliflozin.