Phase 4
N=16
The Effects of Sildenafil on Exercise Function and Capacity in Patients With Fontan Circulation
Fontan Circulation
Bottom Line
View on ClinicalTrials.gov: NCT00964782 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) — 39.4; 36.8; 41.2; 34.4 ml/min/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sildenafil (Drug); Placebo (Drug); Sildenafil 2 (Drug); Placebo 2 (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) |
39.4; 36.8; 41.2; 34.4 | — |
| PRIMARY The Change in Exercise Capacity Measured Via Exercise Time |
11.6; 10.5; 12.1; 10.5 | — |
| SECONDARY The Change in Exercise Capacity Measured Via Maximum Heart Rate |
182.3; 175.4; 182.6; 167.8 | — |
| SECONDARY The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels. |
94.1; 94.6; 93.1; 93.8 | — |
| SECONDARY The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs). |
13.6; 12.4; 14.1; 12.1 | — |
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 Criteria
- Age 6-17 years
- Male or female
- Possess Fontan Circulation
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00964782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.