About the Study

Single Ventricle Condition: A Clinical Trial of a Medication to Increase Exercise Endurance for Adolescents who had a Fontan Procedure

This study is for children: • Age 12-18 years old • Born with a single ventricle and had a Fontan procedure • Currently on blood thinner (i.e. taking medications such as aspirin, heparin, coumadin/warfarin, etc.) The purpose of this study is to find out if the investigational study drug, udenafil, is effective and safe in adolescent participants who have single ventricle heart disease (SVHD) and have undergone a Fontan procedure. Udenafil works to help dilate (open) the blood vessels, which allows for better function of the heart and lungs. The study aims to (1) find out how well udenafil works to improve a patient's ability to exercise and perform everyday activities (2) potentially prevent liver fibrosis, a common complication of SVHD. Patients who participate in the study will be randomly assigned, like flipping of a coin, to receive either udenafil or placebo (does not contain active medication) and have an equal chance (50%) of receiving either udenafil or placebo. Participants will take one tablet by mouth, twice a day, for 26 weeks and be in the study for approximately 7 months.

Interested in learning more?

Full Study Name: Fontan Udenafil Exercise Longitudinal Assessment Trial (the FUEL-2 Study)