Heart Failure
Conditions
Interventions
1. The study setting/ Study sites:
• The National Hospital of Sri Lanka
• Colombo North Teaching Hospital
• Kandy National Hospital
• Colombo South Teaching Hospital
• Jaffna Teaching Hospi
Sponsors
CPC Clinical Research
Eligibility
Inclusion criteria
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 admissionElevated 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
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) 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 • Any other condition or therapy which would make the patient unsuitable for this study and not allow participation for the full planned study period. • Concurrent participation in another interventional clinical study using an investigational agent within 30 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) [Ongoing up to 18months.] Number of serious adverse events (AEs). • Serious AEs (excluding efficacy endpoints). [ Ongoing up to 18months.] Number of adverse events (AEs) leading to discontinuation of study drug. AEs leading to discontinuation of finerenone or empagliflozin. [ Ongoing up to 18months.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of deaths from any cause and total HF events. [Ongoing up to 18months.] Change from baseline in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6. [ At baseline and at 6 months] Number of HF events at Day 90. • Total (first and recurrent) HF events. [ At 90 days] | — |
Countries
Brazil,Canada,India,Spain,Sri Lanka,United Kingdom,United States
Contacts
Public ContactDr. Gamini Galappatthy
Consultant Cardiologist
Outcome results
None listed