Endothelin Blockade in Patients With Single Ventricle Physiology

University of California, Los Angeles10 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Congenital Heart Disease

Interventions

BosentanDRUG

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

UCLA Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months

Magnetic resonance imaging-derived aortic flow

Time frame: 3-6 months

Data from ClinicalTrials.gov

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