Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tadalafil, Placebo.
- Who it may be relevant to
- Registry conditions: Fontan Palliation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
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.
Interventions
- Drug Tadalafil
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 - Drug Placebo
Looks exactly like the study drug, but it contains no active ingredient
Primary outcome measures
- Microvascular endothelial function [Time frame: 52 weeks]
- Pulmonary vascular reserve [Time frame: 52 weeks]
Secondary outcome measures (4)
- Liver stiffness [Time frame: 52 weeks]
- Renal function [Time frame: 52 weeks]
- Exercise capacity [Time frame: 52 weeks]
- Patient reported quality of life [Time frame: 52 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT05206955 · 21-009890 · R01HL160761-01