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.
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
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
Parallel
Finerenone
DrugOral finerenone.
Empagliflozin
DrugOral empagliflozin.
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
Number of serious adverse events (AEs).
\- Serious AEs (excluding efficacy endpoints).
Number of adverse events leading to discontinuation of study drug.
\- AEs leading to discontinuation of finerenone or empagliflozin.
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)
Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).
Number of HF events from baseline to Day 90.
\- Total (first and recurrent) HF events.
Click on the lead sponsor to view all of their trials.
Colorado Prevention Center
Lead sponsor
Saint Luke's Mid America Heart Institute
Collaborator
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Collaborator