Study of Dapagliflozin Treatment for Adults With Failing Fontan Circulation to Assess Heart and Metabolic Effects

What this Trial Is About

Researchers are studying adults with failing Fontan circulation to see if treatment with the drug dapagliflozin over 12 weeks can change peripheral venous pressure at rest and during exercise. This phase II, double-blind study aims to better understand cardiac and metabolic effects in people who have undergone the Fontan procedure and experience symptoms like shortness of breath. Participants will be randomly assigned to take either a 10mg dapagliflozin tablet or a placebo once daily for 12 weeks. The study compares these two groups without knowing which treatment each person receives. The focus is on measuring peripheral venous pressure at rest, with feet elevated, and during exercise at both the start and end of the treatment period. During the study, participants will have their cardiac output, peak oxygen consumption during exercise, blood and plasma volume, body fat and lean mass, and quality of life assessed at the beginning and after 12 weeks. Safety and heart function will be monitored throughout. The total participation time includes baseline assessments, 12 weeks of treatment, and follow-up evaluations up to February 2027.

CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation