Phase 2
N=28
Sildenafil After the Fontan Operation
Hypoplastic Left Heart Syndrome · Tricuspid Atresia
Bottom Line
View on ClinicalTrials.gov: NCT00507819 ↗Enrolled (actual)
28
Serious AEs
1.8%
Results posted
May 2015
Primary outcome: Primary: Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks — 30.5; 30.5; 31.3; 31.3 mL/kg/min — p=0.73
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sildenafil (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks |
30.5; 30.5; 31.3; 31.3 | 0.73 |
| SECONDARY Change From Baseline in Mean Heart Rate (Bpm) at 6 Weeks |
163; 163; 163; 163 | 0.37 |
| SECONDARY Change From Baseline in Mean Respiratory Rate (Breaths/Min) at 6 Weeks |
53.7; 53.0; 51.0; 53.0 | 0.05 |
| SECONDARY Change From Baseline in Mean Minute Ventilation (L/Min) at 6 Weeks |
68.8; 68.1; 67.2; 68.8 | 0.04 sig |
Summary
In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation. The investigators will also evaluate echocardiographic measures of ventricular function and measure quality of life changes using two validated quality of life measures. The hypothesis is that sildenafil will result in increased exercise tolerance in patients who have had the Fontan operation as compared to placebo.
Eligibility Criteria
Inclusion Criteria
- 8 years of age or older
- All participants must have had Fontan completion
Exclusion Criteria
- Height less than 132 cm
- Unable to participate in exercise testing due to medical restrictions or physical limitations
- Fontan baffle obstruction or single lung physiology
- Coarctation of the aorta or neo-aorta (BP gradient > 20 mmHg)
- Severe ventricular dysfunction assessed qualitatively by echocardiography
- Severe atrioventricular valvar regurgitation assessed qualitatively by echocardiography
- Presence of electronic pacemaker
- History of treatment with sildenafil in the six weeks prior to enrollment in study
- Patients with severe renal impairment
- Patients with severe hepatic impairment
- Patients taking medications that inhibit or induce Cytochrome P450 3A4 (CYP3A4) (including grapefruit juice and St. John's Wort)
- Patients taking alpha-blockers and nitrates
- Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Data sourced from ClinicalTrials.gov (NCT00507819). 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.