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.
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,200
Oral finerenone
Matching oral placebo
Composite of total HF events and cardiovascular (CV) death.
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Number of serious adverse events.
Occurrence of 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.
Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Time to first occurrence of the composite of CV death or HF event.
Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Total HF events.
Total HF events with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.
Time frame: 6 Months
Time to CV death.
Time to CV death with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months
Time to death from any cause.
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Glendale, AZ Investigative Site 10096
Glendale, Arizona, United States
RECRUITINGHuntington Beach, CA Investigative Site 10031
Huntington Beach, California, United States
RECRUITINGLos Angeles, CA Investigative Site 10089
Los Angeles, California, United States
RECRUITINGBrooksville, FL Investigative Site 10077
Brooksville, Florida, United States
RECRUITINGMiramar, FL Investigative Site 10113
Miramar, Florida, United States
NOT_YET_RECRUITINGBoise, Idaho Investigative Site 10073
Boise, Idaho, United States
RECRUITINGChicago, IL Investigative Site 10062
Chicago, Illinois, United States
RECRUITINGIndianapolis, IN Investigative Site 10074
Indianapolis, Indiana, United States
RECRUITINGIndianapolis, IN Investigative Site 10008
Indianapolis, Indiana, United States
RECRUITINGMerrillville, IN Investigative Site 10064
Merrillville, Indiana, United States
RECRUITING...and 70 more locations
Time to death from any cause with finerenone compared to placebo.
Time frame: Ongoing, up to ~30 months