NCT01662037

Bosentan Therapy in Children With Functional Single Ventricle

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 4 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Defects
• Functional Single Ventricle

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-09-01
• Completion: 2012-06-01
• First posted: 2012-08-10
• Last updated: 2012-08-10

Locations

1 site across 1 country: China