Endothelin Blockade in Patients With Single Ventricle Physiology

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Actelion
• Treatments: Bosentan

Criteria

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