Endothelin Blockade in Patients With Single Ventricle Physiology

Completed · Not applicable

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT00989911

Run by

University of California, Los Angeles

People needed

10

Starts

2010-05-01

Expected to finish

2013-03-01

Last updated by the study team

2015-02-27

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 12 years of age
• Single ventricle congenital heart disease
• Require cardiac magnetic resonance imaging (MRI) for clinical purposes.

You may not qualify if…

• < 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

Where it is running

• UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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