Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 6 months affects pulmonary capillary wedge pressure (PCWP) at rest and during exercise in adults with failing Fontan circulation.
⁃ Subjects are eligible to be randomized in the study only if all the following inclusion criteria and none of the exclusion criteria apply:
• Signed informed consent prior to any study specific procedures
• History of Fontan procedure
• Male or female subject
• Age ≥ 18
• Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation
• Undergoing clinically indicated cardiac catheterization
• Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥20 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized.