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Bosentan Therapy in Children With Functional Single Ventricle

Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congenital Heart Defects; Functional Single Ventricle

Intervention: Bosentan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Shanghai Jiao Tong University School of Medicine

Official(s) and/or principal investigator(s):
Zhuoming Xu, MD PhD, Study Director, Affiliation: Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center

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.

Clinical Details

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

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

Primary outcome: Length of hospital stay and ICU stay

Secondary outcome:

Symptoms of increased PVR

WHO functional class

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.

Eligibility

Minimum age: 4 Months. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University, Shanghai, Shanghai 200127, China
Additional Information

Starting date: January 2010
Last updated: August 7, 2012

Page last updated: August 23, 2015

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