Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).
This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,600
Oral finerenone.
Matching oral placebo.
FIN-10004 Fairhope, AL Investigational Site
Fairhope, Alabama, United States
RECRUITINGFIN-10075 San Diego, CA Investigational Site
San Diego, California, United States
RECRUITINGTime to first occurrence of cardiovascular (CV) death or HF event.
\- Time to first CV death or HF event with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Number of serious adverse events
\- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Number of adverse events leading to discontinuation of study drug.
\- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Timing and occurrence of total CV deaths and HF events
\- Timing and occurrence of total (first and subsequent) events of CV death and HF events and CV deaths with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Timing and occurrence of total HF events
Timing and occurrence of total (first and recurrent) HF events with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.
\- Change in KCCQ-TSS with finerenone compared to placebo.
Time frame: 180 days
Time to CV death.
\- Time to CV death with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
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FIN-10002 Kansas City, MO Investigational Site
Kansas City, Missouri, United States
FIN-10015 Austin, TX Investigational Site
Austin, Texas, United States
RECRUITINGFIN-21003 Goiania, Goias Investigational Site
Goiânia, Goiás, Brazil
RECRUITINGFIN-21049 Sao Paulo, Investigational Site
Sao Paulp, Sap Paulo, Brazil
RECRUITINGFIN-21004 Braganca Paulista, Investigational Site
Bragança Paulista, São Paulo, Brazil
RECRUITINGFIN-11012 Surrey, BC Investigational Site
Surrey, British Columbia, Canada
RECRUITINGTime to all-cause death.
\- Time to all-cause mortality with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months