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
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 5, 2009
Results First Received: December 3, 2014
Last Updated: February 9, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 28, 2015