Evaluation of Udenafil Treatment for Adolescents Aged 12 to 18 With Single Ventricle Heart Disease After Fontan Procedure

What this Trial Is About

Researchers are evaluating the clinical efficacy and safety of udenafil, an oral drug that selectively inhibits PDE5, compared to a placebo in adolescents who have undergone the Fontan procedure for single ventricle heart disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to measure improvements in exercise capacity and other health markers over 26 weeks. The study focuses on participants aged 12 to less than 19 years with Fontan physiology and is sponsored by Mezzion Pharma Co. Ltd. Participants will be randomly assigned to receive either udenafil or a matching placebo over the 26-week study period. Approximately 218 subjects will receive udenafil and another 218 will receive placebo across about 30 study sites. The main measurement will be the change in peak oxygen consumption during maximal cardiopulmonary exercise testing. Secondary assessments will include changes in ventilatory efficiency, liver fibrosis score, and exercise work rate. During the study, participants will undergo cardiopulmonary exercise tests and other evaluations to monitor respiratory and cardiovascular function, liver health, and exercise capacity. Researchers will track safety and adherence while blinded to treatment assignments. The primary outcome is the change in exercise capacity after 26 weeks. Participants health and safety will be monitored throughout, with study visits and assessments planned at baseline and follow-up intervals over the 26-week duration.

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2