FUEL OLE Clinical Trial

Condition: Fontan physiology

Eligibility

Key Inclusion Criteria

  • Males and females with Fontan physiology who participated in the FUEL trial or, if they did not participate in FUEL, those who are 12 to less than 19 years of age
  • Fluent in English, Spanish, or Korean
  • Participant consent or parental/guardian consent and participant assent

Key Exclusion Criteria

  • Height <132 cm
  • Weight <40 kg
  • Hospitalization for acute decompensated heart failure within the last 12 months

Full Study Name

A Phase III Safety Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation (FUEL EXTENSION) (IRB no. 47772)

Summary

This study focuses on patients who have had a Fontan surgery and who are between 12 and 18 years old. Over time, children and young adults who have had Fontan operation experience a decline in heart function. Often the first sign is a decrease in their exercise ability. The purpose of the study is to evaluate the effects of an investigational drug called udenafil and to determine whether adolescents who have had the Fontan operation can improve their ability to exercise by taking the drug. Udenafil works by making it easier for blood to flow through the lungs and back to the heart. It may also improve overall circulation, including function of the blood vessels in the body and the heart itself. Udenafil has not been approved by the U.S. Food and Drug Administration for treatment of children who have had a Fontan surgery.

Phase

Phase III


Principal Investigator

Ruchira Garg, MD

Contact