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

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)

Overview

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

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).

Interventions

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

Primary outcome measures

• Clinical benefit [Time frame: 6 months]
• Number of serious adverse events (AEs). [Time frame: 6 months]
• Number of adverse events leading to discontinuation of study drug. [Time frame: 6 months]

Secondary outcome measures (3)

• Time to first death from any cause or HF event. [Time frame: 6 months]
• Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS). [Time frame: 6 months]
• Number of HF events from baseline to Day 90. [Time frame: 90 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 34 centers

• CON-21036, Rio Branco, Acre — Rio Branco
• CON-21064, Arapiraca, Alagoas, Brazil — Arapiraca
• CON-21017, Linhares, Espirito Santo — Linhares
• CON-21032, Salvador, Bahia — Salvador
• CON-21028, Brasilia, Distrito Federal — Brasília
• CON-21053, Aparecida de Goiânia, Goias — Aparecida de Goiânia
• CON-21003 Goiania, Goias Investigational Site — Goiânia
• CON-21020, Belo Horizonte, Minas Gerais — Belo Horizonte
• … and 26 more centers

United States · 33 centers

• CON-10004 Fairhope, AL Investigational Site — Fairhope
• CON-10075 El Centro, CA Investigational Site — El Centro
• CON-10024 Sacramento, CA Investigational Site — Sacramento
• CON-10023, San Francisco, CA — San Francisco
• CON-10109, Van Nuys, CA — Van Nuys
• CON-10001, Aurora, CO — Aurora
• CON-10005, Denver, CO — Denver
• CON-10078, Hialeah, FL — Hialeah
• … and 25 more centers

Canada · 10 centers

• CON-11011, Edmonton, AB — Edmonton
• CON-11012 Surry, BC Investigational Site — Surrey
• CON-11016, Sudbury, ON — Greater Sudbury
• CON-11010, London, ON — London
• CON-11007 North York, ON Investigational Site — North York
• CON-11008, Toronto, ON — Toronto
• CON-11019, Toronto, ON — Toronto
• CON-11001, Toronto, ON — Toronto
• … and 2 more centers

China · 10 centers

• CON-56002, Guangzhou, Guangdong province — Guangzhou
• CON-56008, Changsha, Hunan — Changsha
• CON-56004, Jinan, Shandong Province — Jinan
• … and 7 more centers

Spain · 6 centers

Center list to be confirmed — check the primary protocol.

Sri Lanka · 4 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 4 centers

Center list to be confirmed — check the primary protocol.

India · 3 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06024746 · 202303CPC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗