Fontan Udenafil Exercise Longitudinal Assessment Trial - 2 is a study for adolescents aged 12 to 18 who have undergone the Fontan procedure, a heart surgery. The study tests udenafil, a medication that helps blood flow better, against a placebo, or fake pill. Udenafil is a type of drug that stops a chemical called PDE5, which can help improve blood circulation.
The study lasts 26 weeks (about 6 months) and involves several centers. It is "double-blinded," meaning neither the doctors nor the participants know who gets udenafil or the placebo. They measure something called VO2, which is how much oxygen your body uses during exercise, to see if udenafil helps.
Participants must be able to speak the local language and be on blood-thinning medication. They cannot join if they have certain health problems, like severe heart or lung issues, or if they’ve used similar drugs recently. Girls cannot be pregnant during the study.
- The study takes 26 weeks and involves multiple visits.
- Participants must be on blood-thinning medicine.
- Some people with specific health conditions cannot join.