This clinical trial is focused on studying a heart condition known as Heart Failure with reduced ejection fraction (HFrEF). This condition occurs when the heart muscle doesn’t pump blood as well as it should. The study will evaluate a treatment using a medication called Finerenone, which is taken as a film-coated tablet. The medication is also referred to by its code name, BAY 94-8862. Participants in the study will either receive Finerenone or a placebo, which looks like the medication but does not contain the active ingredient.
The purpose of the study is to assess the effectiveness and safety of Finerenone in patients who cannot tolerate or are not eligible for treatment with other medications called steroidal mineralocorticoid receptor antagonists. These are typically used to treat heart failure but may not be suitable for everyone. The study will monitor participants over a period of time to see if Finerenone can help reduce the risk of cardiovascular death or heart failure events, which are serious complications of heart failure.
Participants will be randomly assigned to receive either Finerenone or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will track the time to the first occurrence of cardiovascular death or a heart failure event, as well as other outcomes like changes in symptoms and overall health status. The study is expected to continue until 2028, with recruitment starting in 2025.
Croatia 
Czechia 
Greece 
Hungary 
Italy 
Poland 
Spain 
