drugset / Trial / NCT01291069

Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

NCT01291069

Phase 1 Completed 20 enrolled University of Utah
RandomizedCrossoverTriple-blindTreatment

Summary

This pilot study is aimed at assessing the short-term effects of Tadalafil on the hemodynamic response to exercise and exercise capacity in patients with Fontan circulation. Data regarding effect size and drug tolerability will be used in the design of a randomized multicenter trial. The long-term goal of this investigation is to systematically evaluate the effect of tadalafil therapy on exercise performance, quality of life, and delay of functional deterioration in patients with single ventricle physiology.

Timeline

Start
2011-09
Primary completion
2014-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Tadalafil Small molecule 0.8 mg/kg Oral
Subject Tadalafil Small molecule 1 mg/kg Oral

Indications