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)

NCT05206955•Mayo Clinic

View on ClinicalTrials.gov

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

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

September 16, 2022

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2026

Last Updated

November 14, 2025

Enrollment

ESTIMATED participants

Conditions

Fontan Palliation

Interventions

Tadalafil

DRUG

Placebo

DRUG

Contacts

ACHD Research Team

CONTACT

507-293-2565 RSTACHDRESPRG@mayo.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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