FIORE: Efficacy and safety of finerenone in paediatric HF patients

• Research type

  Research Study

• Full title

  A multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to investigate the efficacy, safety, and PK/ PD of finerenone, in addition to standard-of-care, in pediatric patients, 6 months to < 18 years of age with heart failure (HF) and left ventricular systolic dysfunction (LVSD)

• IRAS ID

  1012181

• Contact name

  Michael Devoy

• Contact email

  clinical-trials-contact@bayer.com

• Sponsor organisation

  Bayer AG

• Research summary

  A study to learn more about how well finerenone works, how safe it is, and how it moves into, through, and out of the body compared to placebo when taken with standard treatment in children with heart failure and left ventricular systolic dysfunction.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  25/NS/0090

• Date of REC Opinion

  29 Sep 2025

• REC opinion

  Further Information Favourable Opinion