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

August 5, 2012
August 7, 2012
January 2010
September 2011   (final data collection date for primary outcome measure)
Length of hospital stay and ICU stay [ Time Frame: 12 months after Fontan operation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01662037 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Bosentan Therapy in Children With Functional Single Ventricle
Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Heart Defects
  • Functional Single Ventricle
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
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
June 2012
September 2011   (final data collection date for primary outcome measure)

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
Both
4 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01662037
SJTUMS-20120314
Yes
Limin Zhu, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Study Director: Zhuoming Xu, MD PhD Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
Shanghai Jiao Tong University School of Medicine
August 2012

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