FINEARTS - HF (Finerenone in Heart Failure Patients)

• Research type

  Research Study

• Full title

  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%)

• IRAS ID

  275797

• Contact name

  Mark Petrie

• Contact email

  Mark.Petrie@glasgow.ac.uk

• Sponsor organisation

  Bayer AG

• Eudract number

  2020-000306-29

• Clinicaltrials.gov Identifier

  NCT04435626

• Duration of Study in the UK

  3 years, 7 months, 19 days

• Research summary

  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.

• REC name

  West of Scotland REC 1

• REC reference

  20/WS/0070

• Date of REC Opinion

  1 Jun 2020

• REC opinion

  Further Information Favourable Opinion