The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6,016
For participants with an eGFR ≤60 mL/min/1.73 m\^2: Starting dose is 10 mg OD and maximum dose 20 mg OD. For participants with an eGFR \>60 mL/min/1.73 m\^2: Starting dose is 20 mg OD and maximum dose 40 mg OD. Finerenone is administered orally as immediate release tablets.
Placebo tablets matching BAY94-8862 are administered orally.
Cardiology, PC
Birmingham, Alabama, United States
Eastern Shore Research Institute, LLC | Fairhope, AL
Fairhope, Alabama, United States
Mobile Heart Specialists - Providence
Mobile, Alabama, United States
University of Arizona Clinical and Translational Sciences Research Center
Tucson, Arizona, United States
Heart Clinic Arkansas
Little Rock, Arkansas, United States
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events
Number of composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Occurrence of the Composite Endpoint of Cardiovascular Death and Total (First and Recurrent) Heart Failure Events
Number of participants with composite endpoint events of cardiovascular death and total (first and recurrent) heart failure (HF) events (hospitalization for heart failure or urgent HF visit) in HF patients.
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Occurrence of Total (First and Recurrent) Heart Failure Events
Number of total (first and recurrent) heart failure events.
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Occurrence of Total (First and Recurrent) Heart Failure Events
Number of participants with total (first and recurrent) heart failure events.
Time frame: From randomization up until the end of study, with an average study duration of 32 months
Change From Baseline in Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) is ranged from 0 to 100. A higher score (closer to 100) reflects fewer symptoms, indicating better heart failure symptom status. For the change from baseline the combined and averaged result across the entire time frame is reported.
Time frame: From baseline to Month 6, 9 and 12
Proportion of Participants Who Showed Improvement in NHYA Class
The New York Heart Association (NYHA) Functional Classification is a simple scale that classifies patients with heart failure based on the severity of their symptoms and how those symptoms affect their physical activity, which ranges from Class I to Class IV, a lower class number is indicative of a better condition. A patient was considered as having improved in NYHA class, if the NYHA class at Month 12 is at least one category improved compared to the baseline visit.
Time frame: from baseline to Month 12
First Occurrence of Renal Composite Events
Number of participants with renal composite events encompassing the components sustained decrease in eGFR ≥50% relative to baseline over at least 4 weeks, sustained eGFR decline to \<15 mL/min/1.73 m2 over at least 4 weeks, initiation of chronic dialysis and renal transplantation.
Time frame: From randomization up to end of study visit, with an average study duration of 32 months
Occurence of All-cause Mortality (Full Analysis Set)
Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.
Time frame: From randomization until end of study, with an average of 32 months
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