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Active, currently enrolling

Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)

NCT No.: NCT06024746

Study Type: INTERVENTIONAL

Phase: Phase III

Region: California - Northern

Acronym: CONFIRMATION

Official Title

Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)

Purpose

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.

Detailed Description

Sex

Male & Female

Age Limit

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

Keywords and/or Specific Medical Conditions

  • Cardiology
  • Hospitalized
  • Heart Failure

Sponsors

  • Colorado Prevention Center

KP Clinical Facility

Clinical Area

  • Cardiology

Principal Investigator

Jana Svetlichnaya  

Contact Information

 - CTP Collaborate Team
- CTPCollaborate@kp.org
- All Kaiser Permanente Northern California Medical Centers

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