Endothelin Blockade in Patients With Single Ventricle Physiology

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Congenital Heart Disease

Treatments

Drug: Bosentan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00989911

Actelion - 1

Details and patient eligibility

About

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.

Full description

Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.

Enrollment

10 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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