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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
  Purpose
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.

Condition Intervention
Congenital Heart Disease Drug: Bosentan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Endothelin Blockade in Patients With Single Ventricle Physiology

Resource links provided by NLM:


Further study details as provided by Jamil Aboulhosn, University of California, Los Angeles:

Primary Outcome Measures:
  • Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months [ Time Frame: 3-6 months ]
    Magnetic resonance imaging-derived aortic flow


Enrollment: 10
Study Start Date: May 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bosentan
Bosentan
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989911


Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Actelion
Investigators
Principal Investigator: Jamil Aboulhosn, MD University of California, Los Angeles
  More Information

Publications:
Responsible Party: Jamil Aboulhosn, Assistant Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00989911     History of Changes
Other Study ID Numbers: Actelion - 1
First Submitted: October 5, 2009
First Posted: October 6, 2009
Results First Submitted: December 3, 2014
Results First Posted: January 13, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

Keywords provided by Jamil Aboulhosn, University of California, Los Angeles:
Single ventricle congenital heart disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action