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Endothelin Blockade in Patients With Single Ventricle Physiology

This study has been completed.
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Jamil Aboulhosn, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00989911
First received: October 5, 2009
Last updated: February 9, 2015
Last verified: February 2015

October 5, 2009
February 9, 2015
May 2010
March 2013   (final data collection date for primary outcome measure)
Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Magnetic resonance imaging-derived aortic flow
Twenty percent increase in pulmonary blood flow as determined by MRI velocity encoding. [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00989911 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Endothelin Blockade in Patients With Single Ventricle Physiology
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.
Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Congenital Heart Disease
Drug: Bosentan
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 Name: Tracleer
Experimental: Bosentan
Bosentan
Intervention: Drug: Bosentan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00989911
Actelion - 1
No
Not Provided
Not Provided
Jamil Aboulhosn, University of California, Los Angeles
University of California, Los Angeles
Actelion
Principal Investigator: Jamil Aboulhosn, MD University of California, Los Angeles
University of California, Los Angeles
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP