Testing Finerenone and Empagliflozin Together for Hospitalized Heart Failure Patients
Tests two heart medicines together, compared with usual care, in adults hospitalized with heart failure.
Plain-language title generated from the registry record
Registry title: A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)
Key facts
- Where
- Ahmedabad, Bangalore, Nagpur, and New Delhi, IndiaSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults hospitalized with heart failure, or recently discharged, who got intravenous diuretics and have raised heart blood markers. It tests finerenone plus empagliflozin against usual care.
- Age
- 18 years or older (or the legal age of adulthood in your country).
- Sex
- All sexes. Women must have a negative pregnancy test and agree to use contraception.
- Disease stage
- Heart failure as the main reason for the current hospital stay or a recent discharge, with heart failure signs and symptoms at admission. NTproBNP ≥500 pg/mL or BNP ≥125 pg/mL (sinus rhythm), or NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL (atrial fibrillation). Must meet the trial's stabilization criteria if randomized in hospital.
- Earlier treatment
- Must have received at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide) during the hospital stay. Cannot be on a non-steroidal MRA or an SGLT2 inhibitor.
- Biomarker or test result
- NTproBNP or BNP above the limits given, measured during this hospital stay or in the 72 hours before admission.
Main reasons for not taking part
- Type 1 diabetes or past diabetic ketoacidosis
- Past severe high potassium while taking an MRA
- eGFR <30 mL/min/1.73m² and/or potassium >5.0 mmol/L
- Recent heart attack, heart procedure or device within 30 days
- Prior or planned heart transplant
Read by machine on 12 November 2026.
Where in India
- CON-51006, Ahmedabad, GujaratAhmedabad, IndiaContact: Bonaca, MDTaking people
- CON-51013, Bangalore, KarnatakaBangalore, IndiaContact: Bonaca, MDTaking people
- CON-51009, Nagpur, MaharashtraNagpur, IndiaContact: Bonaca, MDTaking people
- New Delhi, Delhi Investigative Site CON-51004New Delhi, IndiaContact: Marc Bonaca, MDTaking people
- New Delhi, Delhi Investigative Site CON-51011New Delhi, IndiaContact: Marc Bonaca, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Colorado Prevention Center
- Trial code
- NCT06024746
- Record updated
- 10 September 2026
- Original description
Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.Read full original descriptionShow less
Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 Inhibitor in Patients Hospitalized With Heart Failure (CONFIRMATION-HF)
Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.
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; Prior or planned heart transplant; Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers; Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days; 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; Known hypersensitivity to the IP (active substance or excipients); Any other condition or therapy which would make the patient unsuitable for this study; Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² and/or potassium >5.0 mmol/L.