Endothelin Blockade in Patients With Single Ventricle Physiology
- Registration Number
- NCT00989911
- Lead Sponsor
- University of California, Los Angeles
- Brief Summary
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.
- Detailed Description
Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- At least 12 years of age
- Single ventricle congenital heart disease
- Require cardiac magnetic resonance imaging (MRI) for clinical purposes.
Exclusion Criteria
- < 12 years of age
- Pregnancy or women who may become pregnant (sexually active and unwilling to use birth control)
- Patients taking cyclosporin or glyburide
- Patients with baseline liver dysfunction (aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal)
- Contraindications to MRI (including pacemakers)
- Use of Bosentan within one month prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bosentan Bosentan Bosentan
- Primary Outcome Measures
Name Time Method Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months 3-6 months Magnetic resonance imaging-derived aortic flow
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCLA Medical Center
🇺🇸Los Angeles, California, United States