Endothelin Blockade in Patients With Single Ventricle Physiology

Congenital Heart Disease Clinical Trial

Official title:

Endothelin Blockade in Patients With Single Ventricle Physiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989911
• Other study ID #: Actelion - 1
• Status: Completed
• Phase: N/A
• First received: October 5, 2009
• Last updated: February 9, 2015
• Start date: May 2010
• Est. completion date: March 2013

Study information

• Verified date: February 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Actelion

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Epub 2007 Jun 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months	Magnetic resonance imaging-derived aortic flow	3-6 months	No