Heart Failure
Conditions
Keywords
Heart Failure, Hospitalized
Brief summary
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
DRUGFinerenone
Oral finerenone.
DRUGEmpagliflozin
Oral empagliflozin.
Sponsors
Colorado Prevention Center
Saint Luke's Mid America Heart Institute
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical benefit | 6 months | 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). | 6 months | \- Serious AEs (excluding efficacy endpoints). |
| Number of adverse events leading to discontinuation of study drug. | 6 months | \- AEs leading to discontinuation of finerenone or empagliflozin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first death from any cause or HF event. | 6 months | 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). | 6 months | — |
| Number of HF events from baseline to Day 90. | 90 days | \- Total (first and recurrent) HF events. |
Countries
Brazil, Canada, China, India, Spain, Sri Lanka, United Kingdom, United States
Contacts
CONTACTMarc Bonaca
Outcome results
None listed