A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists.
- Conditions
- Heart condition
- Registration Number
- 2023-508875-35-00
- Lead Sponsor
- Colorado Prevention Center
- Brief Summary
The primary objective is to evaluate the efficacy and safety of finerenone in participants with HFrEF who are intolerant of or not eligible for treatment with sMRA. The safety objective is to assess safety and tolerability of finerenone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the time to first occurrence of cardiovascular death or a heart failure event.
- Secondary Outcome Measures
Name Time Method Secondary endpoints include treatment group differences in: Timing and occurrence of total (first and recurrent) events of cardiovascular (CV) death and heart failure (HF) events. Timing and occurrence of total (first and recurrent) HF events. Change in Kansas City Cardiomyopathy Questionnaire – Total Symptom Score (KCCQ-TSS) from baseline to Month 6. Time to CV death. Time to all-cause death.