Home › NCT05206955

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)

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• Tadalafil (drug)
• Placebo (drug)

Sponsor: Mayo Clinic · Participants: 42 · Started: Sep 16, 2022

Contact the study team

• ACHD Research Team · Phone: 507-293-2565

Official record on ClinicalTrials.gov — NCT05206955

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.