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Endothelin Blockade in Patients With Single Ventricle Physiology

NCT ID: NCT00989911

Last Updated: 2015-02-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-03-31

Brief Summary

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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

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

Conditions

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Congenital Heart Disease

Keywords

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Single ventricle congenital heart disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Bosentan

Bosentan

Group Type EXPERIMENTAL

Bosentan

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Tracleer

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Jamil Aboulhosn

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamil Aboulhosn, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18534975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17563825 (View on PubMed)

Other Identifiers

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Actelion - 1

Identifier Type: -

Identifier Source: org_study_id