Bosentan Therapy in Children With Functional Single Ventricle

Congenital Heart Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662037
• Other study ID #: SJTUMS-20120314
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2012
• Last updated: August 7, 2012
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Congenital Heart Defects
• Functional Single Ventricle
• Heart Defects, Congenital

Intervention

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.

Locations

Country	Name	City	State
China	Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay and ICU stay		12 months after Fontan operation	No
Secondary	Symptoms of increased PVR	facial edema plural effusion pericardium effusion	12 months after Fontan operation	No
Secondary	WHO functional class		12 months after Fontan operation	No