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

Heart Failure Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024746
• Other study ID #: 202303CPC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Colorado Prevention Center
• Contact: Marc Bonaca
• Phone: (303) 860-9900
• Email: info[@]cpcmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Combination therapy with finerenone with empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide electronic or written informed consent, either personally or through a legally authorized representative
• Age =18 years or legal age of majority
• 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) =1000 pg/mL or B-type natriuretic peptide (BNP) =250 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP =2000 pg/mL or BNP =500 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 serum/plasma potassium >5.0 mmol/L
• Type 1 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
• Any other condition or therapy which would make the patient unsuitable for this study

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Finerenone
Oral finerenone.
• Empagliflozin
Oral empagliflozin.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Colorado Prevention Center	Bayer, Saint Luke's Hospital of Kansas City

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit	Hierarchical composite of the following assessed by the win-ratio: Time to death from any cause; Number of HF events; Time to first HF event; Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS)	6 months
Primary	Number of serious adverse events (AEs).	- Serious AEs (excluding efficacy endpoints).	6 months
Primary	Number of adverse events leading to discontinuation of study drug.	- AEs leading to discontinuation of finerenone or empagliflozin.	6 months
Secondary	Number of deaths from any cause and total HF events.	- All-cause mortality and total HF events (first and recurrent).	6 months
Secondary	Change from baseline in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.		6 months
Secondary	Number of HF events at Day 90.	- Total (first and recurrent) HF events.	90 days