Study of Tadalafil Vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

Description

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.

Conditions

Fontan Palliation

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Study Overview

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Study Details

Study overview

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.

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)

Study of Tadalafil Vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

Condition
Fontan Palliation
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Alexander C Egbe, MBBS, MPH, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2026-11