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Bosentan Therapy in Children With Functional Single Ventricle

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662037
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Limin Zhu, Shanghai Jiao Tong University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Length of hospital stay and ICU stay [ Time Frame: 12 months after Fontan operation ]

Secondary Outcome Measures:
  • Symptoms of increased PVR [ Time Frame: 12 months after Fontan operation ]
    facial edema plural effusion pericardium effusion

  • WHO functional class [ Time Frame: 12 months after Fontan operation ]

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

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Ages Eligible for Study:   4 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 5, 2012
First Posted: August 10, 2012
Last Update Posted: August 10, 2012
Last Verified: August 2012

Keywords provided by Limin Zhu, 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
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action