REDEFINE-HF: A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Study Details
Study Description
Brief Summary
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment hospitalized heart failure patients with mildly reduced or preserved ejection fraction.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Finerenone
|
Drug: Finerenone
Oral finerenone
Other Names:
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Matching oral placebo
|
Outcome Measures
Primary Outcome Measures
- Composite total of HF events and cardiovascular (CV) death. [Ongoing, up to ~30 months]
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
- Number of serious adverse events. [Ongoing, up to ~30 months]
Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
- Number of adverse events leading to discontinuation of study drug. [Ongoing, up to ~30 months]
Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
Secondary Outcome Measures
- Time to first occurrence of the composite of CV death or HF event. [Ongoing, up to ~30 months]
Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
- Total HF events. [Ongoing, up to ~30 months]
Total HF events with finerenone compared to placebo.
- Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6. [6 Months]
- Time to CV death. [Ongoing, up to ~30 months]
Time to CV death with finerenone compared to placebo.
- Time to death from any cause. [Ongoing, up to ~30 months]
Time to death from any cause with finerenone compared to placebo.
Other Outcome Measures
- Total hospitalizations for any cause. [Ongoing, up to ~30 months]
Total hospitalizations for any cause with finerenone compared to placebo.
- Total number of days alive and out of the hospital. [Ongoing, up to ~30 months]
Days alive and out of hospital with finerenone compared to placebo.
- Number of patients with sustained decrease in eGFR ≥40% relative to baseline. [Ongoing, up to ~30 months]
Sustained decrease in eGFR ≥40% relative to baseline with finerenone compared to placebo.
- Number of patients with sustained eGFR <15 ml/min/1.73 m^2. [Ongoing, up to ~30 months]
Sustained eGFR <15 ml/min/1.73 m^2 with finerenone compared to placebo.
- Number of patients requiring initiation of dialysis or renal transplant. [Ongoing, up to ~30 months]
Initiation of dialysis or renal transplant with finerenone compared to placebo.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Provide electronic or written informed consent, either personally or through a legally authorized representative
-
Age ≥18 years
-
Current hospitalization or recently discharged with the primary diagnosis of heart failure
-
Heart failure signs and symptoms at the time of hospital admission
-
Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
-
Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF
Exclusion Criteria:
-
Treatment with a mineralocorticoid receptor antagonist (MRA)
-
Documented prior history of severe hyperkalemia in the setting of MRA use
-
Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or serum/plasma potassium >5.0 mmol/L at screening
-
Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
-
Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
-
Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Colorado Prevention Center
- Saint Luke's Hospital of Kansas City
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202301CPC