A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)
Mayo Clinic
Summary
The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients ≥ 18 years old. * Have previously undergone a Fontan Palliation. * Able to exercise using a supine bike. * Ability and willingness to provide written consent. * Undergoing a clinically indicated Cardiac Catheterization Exclusion Criteria: * Patients \< 18 years old. * Current intravenous inotropic drugs. * Current use of alpha-blockers, pulmonary vasodilators, or nitrates. * Unable to exercise. * Pregnancy or lactating. * Unable or unwilling to consent.
Interventions
- DrugTadalafil
10 mg once daily orally week 1, 20 mg once daily orally during week 2, and 40 mg once daily orally during weeks 3 through 52
- DrugPlacebo
Looks exactly like the study drug, but it contains no active ingredient
Location
- Mayo ClinicRochester, Minnesota