Endothelin Blockade in Patients With Single Ventricle Physiology
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Endothelin Blockade in Patients With Single Ventricle Physiology|
- Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]Magnetic resonance imaging-derived aortic flow
|Study Start Date:||May 2010|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
Other Name: Tracleer
Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989911
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Jamil Aboulhosn, MD||University of California, Los Angeles|