Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
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
80 participants
Sep 16, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria6
- 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.
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Interventions
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
Looks exactly like the study drug, but it contains no active ingredient
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05206955