Overview

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