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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Finerenone; Drug: Empagliflozin

Detailed Description

This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marc Bonaca; Phone Number: (303) 860-9900; Email: info@cpcmed.org

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05652-900
    • Recruiting
    • CON-21049 Sao Paulo, Sao Paulo Investigational Site
  • Goias
    • Goiania, Goias, Brazil, 74453-200
      • Recruiting
      • CON-21003 Goiania, Goias Investigational Site
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89200-000
      • Recruiting
      • CON-21007 Joinville, Santa Catarina Investigational Site
  • Sao Paulo
    • Braganca Paulista, Sao Paulo, Brazil, 12916542
      • Recruiting
      • CON-21004 Braganca Paulista, Sao Paulo Investigational Site
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V OC6
      • Recruiting
      • CON-11012 Surry, BC Investigational Site
  • Ontario
    • North York, Ontario, Canada, M6B 3H7
      • Recruiting
      • CON-11007 North York, ON Investigational Site
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • CON-11005 Sherbrooke, QC Investigational Site
• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Recruiting
      • CON-10004 Fairhope, AL Investigational Site
  • California
    • El Centro, California, United States, 92243
      • Recruiting
      • CON-10075 El Centro, CA Investigational Site
    • Sacramento, California, United States, 95816
      • Recruiting
      • CON-10024 Sacramento, CA Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • CON-10022 Atlanta, GA Investigational Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • CON-10030 Baton Rouge, LA Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • CON-10002 Kansas City, MO Investigative Site
      • Contact: Marc Bonaca
  • Texas
    • Amarillo, Texas, United States, 79106
      • Recruiting
      • CON-10045 Amarillo, TX Investigational Site
    • Austin, Texas, United States, 78705
      • Recruiting
      • CON-10015 Austin, TX Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finerenone plus empagliflozin	Drug: Finerenone; Oral finerenone.; Drug: Empagliflozin; Oral empagliflozin.
No Intervention: Usual care; Usual care management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of serious adverse events (AEs).	- Serious AEs (excluding efficacy endpoints).	6 months
Number of adverse events leading to discontinuation of study drug.	- AEs leading to discontinuation of finerenone or empagliflozin.	6 months
Clinical benefit	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first death from any cause or HF event.	Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF)	6 months
Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).		6 months
Number of HF events from baseline to Day 90.	- Total (first and recurrent) HF events.	90 days

Collaborators and Investigators

• Sponsor: Colorado Prevention Center
• Collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma; Saint Luke's Mid America Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Hospitalized
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Empagliflozin
• Other Study ID Numbers: 202303CPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share individual patient data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No