Completed
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
What is being tested
Sildenafil
+ Placebo 2
+ Placebo
Drug
Who is being recruted
From 6 to 17 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 4
Interventional
Study Start: August 2009
Summary
Principal SponsorMilton S. Hershey Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2009
Actual date on which the first participant was enrolled.The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.
Official TitleThe Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Principal SponsorMilton S. Hershey Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
17 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Age 6-17 years
Male or female
Possess Fontan Circulation
7 exclusion criteria prevent from participating
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)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorSildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2, placebo drug administered before the exercises.
Group II
PlaceboPatient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2 Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Penn State Hershey Medical Center
Hershey, United StatesOpen Penn State Hershey Medical Center in Google MapsCompletedOne Study Center