Cardiac and Metabolic Effects of Dapagliflozin in the Failing Fontan Circulation: A Phase II, Prospective, Double-Blind Study
Mayo Clinic
Summary
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Signed informed consent prior to any study specific procedures 2. History of Fontan procedure 3. Male or female subject 4. Age ≥ 18 5. Symptoms of dyspnea (NYHA II-IV) with no non-cardiac or ischemia explanation 6. Elevated peripheral venous pressure (PVP) at rest or 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. Exclusion Criteria 1. Type I diabetes 2. Any of the following medications: Insulin or Pramlintide, Sa…
Interventions
- DrugDapagliflozin tablet
Patient will take a 10mg tablet of Dapagliflozin once daily for 12 weeks
- DrugPlacebo Tablet
Patient will take 10mg placebo tablet once daily for 12 weeks
Location
- Mayo ClinicRochester, Minnesota