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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Heart Defects
Functional Single Ventricle
 Drug: Bosentan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle

Resource links provided by NLM:

Drug Information available for: Bosentan
U.S. FDA Resources

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Length of hospital stay and ICU stay [ Time Frame: 12 months after Fontan operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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.

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

Ages Eligible for Study:   4 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662037

Locations
China, Shanghai
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Zhuoming Xu, MD PhD Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
  More Information

No publications provided

Responsible Party: Limin Zhu, Attendant doctor, Department of thoracic and cardiovascular surgery, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01662037     History of Changes
Other Study ID Numbers: SJTUMS-20120314
Study First Received: August 5, 2012
Last Updated: August 7, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Pulmonary vascular resistance
Heart defects, Congenital
Receptors, endothelin
Bosentan

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
 Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013