Status:
COMPLETED
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Children's Miracle Network
Conditions:
Fontan Circulation
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- Age 6-17 years
- Male or female
- Possess Fontan Circulation
Exclusion
- Severe heart failure (New York Heart Ass. functional class IV)
- Evidence of Fontan pathway obstruction
- History of exercise-induced severe arrhythmias
- Pregnancy (known or suspected)
- Orthopedic limitations that prevent ambulation on a treadmill
- Use of nitroglycerin
- Herbal medications
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00964782
Start Date
August 1 2009
End Date
May 24 2012
Last Update
March 26 2019
Active Locations (1)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033