This study, called the Fontan Udenafil Exercise Longitudinal Assessment Trial - 2, is looking at how well a drug called udenafil works compared to a placebo (an inactive substance that looks like the drug) in adolescents who have had a Fontan procedure for single ventricle heart disease. Researchers want to see if udenafil can improve your exercise ability. You might be able to join if you are between 12 and 18 years old, have Fontan physiology, and meet certain height and weight requirements. The study will measure changes in your exercise capacity over 26 weeks. The current recruitment status is unclear, but the study plans to enroll 436 participants.

Study design

This is a 26-week, multicenter, randomized, double-blinded, placebo-controlled study, meaning participants will be randomly assigned to receive either udenafil or placebo, and neither you nor your doctors will know which you are receiving. The study plans to enroll 436 participants.

What's involved

You would participate in the study for 26 weeks, during which your exercise capacity will be measured at the beginning and at the end of this period.

Compensation

Not stated in the trial record.

Follow-up

Your exercise capacity will be measured at 26 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.