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)

Date Added
July 22nd, 2026
PRO Number
Pro00148694
Researcher
Katerina Boucek

List of Studies

Keywords
Heart, Pediatrics
Summary

This is a 3 month study for pediatric patients between the ages of 6 months and 18 years that have a current diagnosis of heart failure. This study will compare the use of the medication finerenone to placebo. During the study, participants will continue to receive their standard of care therapy according to pediatric heart failure guidelines. At the end of the 3 month study period, participants will have the option to enroll in a 9 month open label extension.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8317
wakefies@musc.edu

A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)

Date Added
August 28th, 2026
PRO Number
Pro00149200
Researcher
Katerina Boucek

List of Studies

Keywords
Heart, Pediatrics
Summary

The FIORELLO study is for pediatric patients who 1) Have heart failure and left ventricular systolic dysfunction associated with dilated cardiomyopathy or congenital heart disease and 2) Have successfully completed the FIORE trial. Study participants will receive the study drug finerenone, which has not yet been FDA approved for this specific pediatric population. The study will last 9 months and the objective is to show that finerenone in addition to standard of care is safe when given long-term to pediatric patients with left ventricular systolic dysfunction.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
8437928317
wakefies@musc.edu



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