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 Phase 3 RECRUITING

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.

Details

Lead sponsor	Mayo Clinic
Phase	Phase 3
Status	RECRUITING
Enrolment	80
Start date	2022-09-16
Completion	2026-11

Conditions

• Fontan Palliation

Interventions

• Tadalafil
• Placebo

Primary outcomes

• Microvascular endothelial function — 52 weeks
  Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)
• Pulmonary vascular reserve — 52 weeks
  The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)

Countries

United States