The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
17
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.
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.
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).
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2)
A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test
Time frame: baseline to 1 hour
The Change in Exercise Capacity Measured Via Exercise Time
A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test
Time frame: baseline to 1 hour
The Change in Exercise Capacity Measured Via Maximum Heart Rate
A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test
Time frame: Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels.
A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test
Time frame: Baseline to 1 Hour
The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs).
A change in exercise capacity measured via metabolic equivalents of task (METs). The measurement will be obtained from the Exercise Stress Test. One MET is defined as 3.5 mL 02 uptake/kg per minute
Time frame: Baseline to 1 hour
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Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil).