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Bosentan Therapy in Children With Functional Single Ventricle

Primary Purpose

Congenital Heart Defects, Functional Single Ventricle

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bosentan
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects focused on measuring Pulmonary vascular resistance, Heart defects, Congenital, Receptors, endothelin, Bosentan

Eligibility Criteria

4 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bosentan group

Routinely group

Arm Description

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.

Routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.

Outcomes

Primary Outcome Measures

Length of hospital stay and ICU stay

Secondary Outcome Measures

Symptoms of increased PVR
facial edema plural effusion pericardium effusion
WHO functional class

Full Information

First Posted
August 5, 2012
Last Updated
August 7, 2012
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01662037
Brief Title
Bosentan Therapy in Children With Functional Single Ventricle
Official Title
Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Functional Single Ventricle
Keywords
Pulmonary vascular resistance, Heart defects, Congenital, Receptors, endothelin, Bosentan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bosentan group
Arm Type
Experimental
Arm Description
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.
Arm Title
Routinely group
Arm Type
No Intervention
Arm Description
Routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.
Intervention Type
Drug
Intervention Name(s)
Bosentan
Other Intervention Name(s)
Tracleer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of hospital stay and ICU stay
Time Frame
12 months after Fontan operation
Secondary Outcome Measure Information:
Title
Symptoms of increased PVR
Description
facial edema plural effusion pericardium effusion
Time Frame
12 months after Fontan operation
Title
WHO functional class
Time Frame
12 months after Fontan operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuoming Xu, MD PhD
Organizational Affiliation
Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

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Bosentan Therapy in Children With Functional Single Ventricle

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