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OpenTrials
Completed

NCT Number: NCT00989911

Endothelin Blockade in Patients With Single Ventricle Physiology

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Medical Center

Los Angeles, California, 90095, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

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.

Other names: Tracleer

Primary outcomes

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

    Time frame: 3-6 months

    Magnetic resonance imaging-derived aortic flow

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Actelion

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2009
Registry last updated
Feb 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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