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Endothelin Blockade in Patients With Single Ventricle Physiology

This study is currently recruiting participants.
Verified June 2012 by University of California, Los Angeles
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: June 12, 2012
Last verified: June 2012
History of Changes
  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: Allocation: Non-Randomized
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:

MedlinePlus related topics: Heart Diseases
Drug Information available for: Bosentan
U.S. FDA Resources

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

Primary Outcome Measures:
  • Twenty percent increase in pulmonary blood flow as determined by MRI velocity encoding. [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 13
Study Start Date: May 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

  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 (AST or ALT > 3 times upper limit of normal)
  • Contraindications to MRI (including pacemakers)
  • Use of Bosentan within one month prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989911

Contacts
Contact: Jamil Aboulhosn, MD (310) 794-9629 JAboulhosn@mednet.ucla.edu
Contact: Ryan Williams, BS RJWilliams@mednet.ucla.edu

Locations
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Jamil Aboulhosn, MD     310-794-9629     JAboulhosn@mednet.ucla.edu    
Principal Investigator: Jamil Aboulhosn, MD            
Sub-Investigator: Juan C Alejos, MD            
Sub-Investigator: Paul Finn, MD            
Sponsors and Collaborators
University of California, Los Angeles
Actelion
  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
Last Updated: June 12, 2012
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 Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
 Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013