NCT00964782

The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.

Conditions

• Fontan Circulation

Interventions

Type	Name	Description
DRUG	Sildenafil	oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo.
DRUG	Placebo	Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil.
DRUG	Sildenafil 2	oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo).
DRUG	Placebo 2	Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-05-24
• Completion: 2012-05-24
• First posted: 2009-08-25
• Last updated: 2019-03-26
• Results posted: 2019-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study