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
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Congenital Heart Disease
Intervention: Drug: Bosentan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bosentan 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.

Participant Flow:   Overall Study
    Bosentan  
STARTED     10  
COMPLETED     7  
NOT COMPLETED     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Fontan, single ventricle patients all treated with Bosentan.

Reporting Groups
  Description
Bosentan 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.

Baseline Measures
    Bosentan  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  34  (10.9)  
Gender  
[units: participants]
 
Female     7  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures

1.  Primary:   Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months   [ Time Frame: 3-6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jamil Aboulhosn
Organization: Ahamanson/UCLA ACHDC
phone: 3108255950
e-mail: jaboulhosn@mednet.ucla.edu


Publications:

Responsible Party: Jamil Aboulhosn, 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