Bosentan Therapy in Children With Functional Single Ventricle

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Limin Zhu, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT01662037

First received: August 5, 2012

Last updated: August 7, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2012

Last Updated Date

August 7, 2012

Start Date ^ICMJE

January 2010

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Length of hospital stay and ICU stay [ Time Frame: 12 months after Fontan operation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01662037 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Symptoms of increased PVR [ Time Frame: 12 months after Fontan operation ] [ Designated as safety issue: No ]
facial edema plural effusion pericardium effusion
WHO functional class [ Time Frame: 12 months after Fontan operation ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bosentan Therapy in Children With Functional Single Ventricle

Official Title ^ICMJE

Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle

Brief Summary

Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to investigate if Bosentan therapy can modify the outcome of children with functional single ventricle.

Detailed Description

Increased pulmonary vascular resistance (PVR) is a serous issues in children with functional single ventricle during the staged operative period. The purpose of this study is to investigate if Bosentan therapy can improve the survival and life quality after staged Fontan procedure in the children with high risk of increased PVR.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Congenital Heart Defects
Functional Single Ventricle

Intervention ^ICMJE

Drug: Bosentan

Bosentan 2mg/kg/dose twice a day and routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.

Other Name: Tracleer

Study Arm (s)

Experimental: Bosentan group
Bosentan 2mg/kg/dose twice a day and routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.

Intervention: Drug: Bosentan
No Intervention: Routinely group
Routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Signed informed consent obtained from patient's legally acceptable representative.
Pediatric patients waiting for staged Fontan procedure with high risk of increased PVR after bidirectional cavopulmonary connection (BCPC)
- Transpulmonary pressure gradiant (TPG) > 10mmHg when the obstruction of anastomosis and lung problem were excluded.
- With the diagnosis of high risk of increased PVR, such as associated with TAPVC, after pulmonary artery banding, after systemic to pulmonary shunt more than 6 months, and et al.
- Diagnosed as increased PVR with catheterization.

Exclusion Criteria:

PAH associated with conditions other than those mentioned above, e.g., iPAH, PAH secondary to portal hypertension, HIV patient with opportunistic infection
Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
AST and/or ALT > 3 times the upper limit of normal ranges.
Hemoglobin concentration < 75% the lower limit of normal ranges
Treatment or planned treatment with another investigational drug within 3 months of screening
Treatment with calcineurin-inhibitors (e.g., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of enrollment of this study
Known hypersensitivity to bosentan or any of the excipients

Gender

Both

Ages

4 Months to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01662037

Other Study ID Numbers ^ICMJE

SJTUMS-20120314

Has Data Monitoring Committee

Yes

Responsible Party

Limin Zhu, Shanghai Jiao Tong University School of Medicine

Study Sponsor ^ICMJE

Shanghai Jiao Tong University School of Medicine

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Zhuoming Xu, MD PhD

Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center

Information Provided By

Shanghai Jiao Tong University School of Medicine

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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