RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2022-09-16
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05206955

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients ≥ 18 years old.
  2. * Have previously undergone a Fontan Palliation.
  3. * Able to exercise using a supine bike.
  4. * Ability and willingness to provide written consent.
  5. * Undergoing a clinically indicated Cardiac Catheterization
  1. * Patients \< 18 years old.
  2. * Current intravenous inotropic drugs.
  3. * Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
  4. * Unable to exercise.
  5. * Pregnancy or lactating.
  6. * Unable or unwilling to consent.

Contacts and Locations

Study Contact

ACHD Research Team
CONTACT
507-293-2565
RSTACHDRESPRG@mayo.edu

Principal Investigator

Alexander C Egbe, MBBS, MPH
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-16
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-09-16
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Fontan Palliation