NCT01291069

Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 8 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Single Ventricle

Interventions

Type	Name	Description
DRUG	Tadalafil Citrate	If allocated to the treatment arm, the patient will be given tadalfil citrate, 0.8-1 mg/kg/day in 1 daily dose. Maximum dose 40 mg. All patients will receive either study drug or placebo for a total of 20 days.
DRUG	Sugar pill	If allocated to the placebo arm, the child will be given a similar appearing medication; the placebo will be a mixture of Ora-Sweet® and Ora-Plus® in a 1:1 ratio. All patients will receive drug for 20 days

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-02-07
• Last updated: 2017-04-17

Locations

1 site across 1 country: United States