Sildenafil After the Fontan Operation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00507819
• Date of registration: 25/07/2007
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital of Philadelphia
• Public title: Sildenafil After the Fontan Operation SAFO
• Scientific title: The Sildenafil After Fontan Operation Study
• Date of first enrolment: December 2007
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00507819
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jack Rychik, MD
• Affiliation: Children's Hospital of Philadelphia

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tricuspid Atresia

Hypoplastic Left Heart Syndrome

Intervention(s)

Drug: Sildenafil

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Mean Oxygen Consumption (mL/kg/Min) at 6 Weeks [Time Frame: Baseline and 6 Weeks]

Secondary Outcome(s)

Change From Baseline in Mean Minute Ventilation (L/Min) at 6 Weeks [Time Frame: Baseline and 6 Weeks]

Change From Baseline in Mean Respiratory Rate (Breaths/Min) at 6 Weeks [Time Frame: Baseline and 6 Weeks]

Change From Baseline in Mean Heart Rate (Bpm) at 6 Weeks [Time Frame: Baseline and 6 Weeks]

Secondary ID(s)

IRB 2007-4-5034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Mark H. and Blanche M. Harrington Foundation

Results

• Results available: Yes
• Date Posted: 05/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00507819