Status:
COMPLETED
Endothelin Blockade in Patients With Single Ventricle Physiology
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Actelion
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
12+ years
Phase:
NA
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 e...
Detailed Description
Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.
Eligibility Criteria
Inclusion
- At least 12 years of age
- Single ventricle congenital heart disease
- Require cardiac magnetic resonance imaging (MRI) for clinical purposes.
Exclusion
- \< 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00989911
Start Date
May 1 2010
End Date
March 1 2013
Last Update
February 27 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Medical Center
Los Angeles, California, United States, 90095