Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 4, 2013
Last verified: November 2013

October 5, 2009
November 4, 2013
May 2010
March 2013   (final data collection date for primary outcome measure)
Twenty percent increase in pulmonary blood flow as determined by MRI velocity encoding. [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
Same as current
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
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
Intervention: Drug: Bosentan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
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 (AST or ALT > 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00989911
Actelion - 1
No
Jamil Aboulhosn, University of California, Los Angeles
University of California, Los Angeles
Actelion
Not Provided
University of California, Los Angeles
November 2013

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