Endothelin Blockade in Patients With Single Ventricle Physiology

NCT00989911 | Completed Results

• 1 other identifier: Actelion - 1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Single ventricle congenital heart disease

Outcome Measures

Primary Outcomes (1)

• Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months

  Magnetic resonance imaging-derived aortic flow

  3-6 months

Study Arms (1)

Bosentan

EXPERIMENTAL

Bosentan

Drug: Bosentan

Interventions

Bosentan DRUG

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.

Also known as: Tracleer

Bosentan

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 12 years of age
• Single ventricle congenital heart disease
• Require cardiac magnetic resonance imaging (MRI) for clinical purposes.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Actelion: collaborator

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related 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.

  PMID: 18534975 BACKGROUND

• 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.

  PMID: 17563825 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jamil Aboulhosn
• Organization: Ahamanson/UCLA ACHDC

jaboulhosn@mednet.ucla.edu

3108255950

Study Officials

• Jamil Aboulhosn, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: May 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 27, 2015
• Results First Posted: January 13, 2015

Record last verified: 2015-02

Locations

US (1)