FINEARTS - HF (Finerenone in Heart Failure Patients)
A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥ 40% (LVEF ≥ 40%)
Duration of Study in the UK
3 years, 7 months, 19 days
Heart failure (HF) is usually a chronic progressive disease defined as the reduction in the ability of the heart to contract and/or fill effectively. Patients with heart failure have symptoms like shortness of breath, fatigue and swollen ankles. The diagnosis of heart failure is based on assessments that can measure how much blood the heart can pump around, elevated laboratory parameter and clinical symptoms. For patients with a low heart function numerous internationally approved treatment options are available. However, for the increasing number of patients with a mildly impaired heart function no treatment has yet been approved despite the high risk for mortality and morbidity.
In the FINEARTS-HF-study the effectiveness and safety of finerenone will be investigated in heart failure patients with mildly impaired heart function and compared to placebo. Finerenone is to be taken once daily orally and works by blocking the effects of the hormone aldosterone. It was shown that overactivation of aldosterone over a long duration has undesirable effects causing organ damage like heart and kidney failure. The most common (1-10%) possible side effects are increased potassium in the blood and changes in renal function.
The objective of this study is to demonstrate the superiority of finerenone to placebo in reducing the rate of cardiovascular death and heart failure events (hospitalisation for HF or urgent HF visit) in symptomatic HF patients with mildly impaired heart function. Also changes in the quality of life will be assessed by means of a questionnaire and the time to first occurrence of decrease in renal function.
West of Scotland REC 1
Date of REC Opinion
1 Jun 2020
Further Information Favourable Opinion