The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
- Conditions
- Fontan Circulation
- Interventions
- Registration Number
- NCT00964782
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
- Age 6-17 years
- Male or female
- Possess Fontan Circulation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sildenafil crossover to placebo Sildenafil Sildenafil 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. Sildenafil crossover to placebo Placebo 2 Sildenafil 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. Placebo crossover to sidenafil Placebo Patient 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. Placebo crossover to sidenafil Sildenafil 2 Patient 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.
- Primary Outcome Measures
Name Time Method The Change in Exercise Capacity Measured Via Exercise Time baseline to 1 hour A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test
The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) baseline to 1 hour A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test
- Secondary Outcome Measures
Name Time Method The Change in Exercise Capacity Measured Via Maximum Heart Rate Baseline to 1 Hour A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test
The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels. Baseline to 1 Hour A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test
The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs). Baseline to 1 hour 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
Trial Locations
- Locations (1)
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States