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Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Sponsor: 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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-09-16
Completion Date
2026-11
Last Updated
2025-11-14
Healthy Volunteers
No
Conditions
Interventions
Tadalafil
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
Placebo
Looks exactly like the study drug, but it contains no active ingredient
Locations (1)
Mayo Clinic
Rochester, Minnesota, United States