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Endothelin Blockade in Patients With Single Ventricle Physiology

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989911
First Posted: October 6, 2009
Last Update Posted: February 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Actelion
Information provided by (Responsible Party):
Jamil Aboulhosn, University of California, Los Angeles
October 5, 2009
October 6, 2009
December 3, 2014
January 13, 2015
February 27, 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 ]
Magnetic resonance imaging-derived aortic flow
Twenty percent increase in pulmonary blood flow as determined by MRI velocity encoding. [ Time Frame: 4-6 months ]
Complete list of historical versions of study NCT00989911 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
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