Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Finerenone (BAY94-8862) — DRUG
  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 — OTHER
  Placebo tablets matching BAY94-8862 are administered orally.

Study Details

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.

Key Dates

Start date

Sep 14, 2020

Status verified

Aug 2025

Primary completion

May 15, 2024

Completion

Jun 14, 2024

Study Design

Enrollment

6,016 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1_BAY94-8862
  Adult patients receive BAY94-8862
• Placebo Comparator: Arm 2_Placebo
  Adult patients receive placebo

Primary Outcome Measure

Occurrence of the Composite Endpoint of Cardiovascular Death and 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 ]

Locations (107)

Related coverage on Hipa.ai

• Finerenone Reduces CV Death, HF Events in Heart Failure with LVEF ≥40%
  Finerenone · Aug 26, 2025 · ClinicalTrials.gov

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