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Endothelin Blockade in Patients With Single Ventricle Physiology

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bosentan
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease focused on measuring Single ventricle congenital heart disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bosentan

Arm Description

Bosentan

Outcomes

Primary Outcome Measures

Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months
Magnetic resonance imaging-derived aortic flow

Secondary Outcome Measures

Full Information

First Posted
October 5, 2009
Last Updated
February 9, 2015
Sponsor
University of California, Los Angeles
Collaborators
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00989911
Brief Title
Endothelin Blockade in Patients With Single Ventricle Physiology
Official Title
Endothelin Blockade in Patients With Single Ventricle Physiology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Single ventricle congenital heart disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bosentan
Arm Type
Experimental
Arm Description
Bosentan
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
Tracleer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months
Description
Magnetic resonance imaging-derived aortic flow
Time Frame
3-6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamil Aboulhosn, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18534975
Citation
Giardini A, Balducci A, Specchia S, Gargiulo G, Bonvicini M, Picchio FM. Effect of sildenafil on haemodynamic response to exercise and exercise capacity in Fontan patients. Eur Heart J. 2008 Jul;29(13):1681-7. doi: 10.1093/eurheartj/ehn215. Epub 2008 Jun 4.
Results Reference
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PubMed Identifier
17563825
Citation
Votava-Smith JK, Perens GS, Alejos JC. Bosentan for increased pulmonary vascular resistance in a patient with single ventricle physiology and a bidirectional Glenn shunt. Pediatr Cardiol. 2007 Jul-Aug;28(4):314-6. doi: 10.1007/s00246-007-0037-4. Epub 2007 Jun 11.
Results Reference
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Learn more about this trial

Endothelin Blockade in Patients With Single Ventricle Physiology

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