<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01662037</url>
  </required_header>
  <id_info>
    <org_study_id>SJTUMS-20120314</org_study_id>
    <nct_id>NCT01662037</nct_id>
  </id_info>
  <brief_title>Bosentan Therapy in Children With Functional Single Ventricle</brief_title>
  <official_title>Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bosentan is a kind of dual endothelin receptor antagonist.The purpose of this study is to&#xD;
      investigate if Bosentan therapy can modify the outcome of children with functional single&#xD;
      ventricle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increased pulmonary vascular resistance (PVR) is a serous issues in children with functional&#xD;
      single ventricle during the staged operative period. The purpose of this study is to&#xD;
      investigate if Bosentan therapy can improve the survival and life quality after staged Fontan&#xD;
      procedure in the children with high risk of increased PVR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay and ICU stay</measure>
    <time_frame>12 months after Fontan operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms of increased PVR</measure>
    <time_frame>12 months after Fontan operation</time_frame>
    <description>facial edema plural effusion pericardium effusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO functional class</measure>
    <time_frame>12 months after Fontan operation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Congenital Heart Defects</condition>
  <condition>Functional Single Ventricle</condition>
  <arm_group>
    <arm_group_label>Bosentan group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routinely group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bosentan</intervention_name>
    <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.</description>
    <arm_group_label>Bosentan group</arm_group_label>
    <other_name>Tracleer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent obtained from patient's legally acceptable representative.&#xD;
&#xD;
          -  Pediatric patients waiting for staged Fontan procedure with high risk of increased PVR&#xD;
             after bidirectional cavopulmonary connection (BCPC)&#xD;
&#xD;
               -  Transpulmonary pressure gradiant (TPG) &gt; 10mmHg when the obstruction of&#xD;
                  anastomosis and lung problem were excluded.&#xD;
&#xD;
               -  With the diagnosis of high risk of increased PVR, such as associated with TAPVC,&#xD;
                  after pulmonary artery banding, after systemic to pulmonary shunt more than 6&#xD;
                  months, and et al.&#xD;
&#xD;
               -  Diagnosed as increased PVR with catheterization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PAH associated with conditions other than those mentioned above, e.g., iPAH, PAH&#xD;
             secondary to portal hypertension, HIV patient with opportunistic infection&#xD;
&#xD;
          -  Psychotic, addictive or other disorder limiting the ability to provide informed&#xD;
             consent or to comply with study requirements&#xD;
&#xD;
          -  AST and/or ALT &gt; 3 times the upper limit of normal ranges.&#xD;
&#xD;
          -  Hemoglobin concentration &lt; 75% the lower limit of normal ranges&#xD;
&#xD;
          -  Treatment or planned treatment with another investigational drug within 3 months of&#xD;
             screening&#xD;
&#xD;
          -  Treatment with calcineurin-inhibitors (e.g., cyclosporine A and tacrolimus),&#xD;
             fluconazole, glibenclamide (glyburide) within 1 week of enrollment of this study&#xD;
&#xD;
          -  Known hypersensitivity to bosentan or any of the excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhuoming Xu, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Limin Zhu</investigator_full_name>
    <investigator_title>Attendant doctor, Department of thoracic and cardiovascular surgery</investigator_title>
  </responsible_party>
  <keyword>Pulmonary vascular resistance</keyword>
  <keyword>Heart defects, Congenital</keyword>
  <keyword>Receptors, endothelin</keyword>
  <keyword>Bosentan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Univentricular Heart</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bosentan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01662037
org study id: SJTUMS-20120314
nct id: NCT01662037
lead sponsor: 
has dmc: Yes
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of hospital stay and ICU stay
time frame: 12 months after Fontan operation
measure: Symptoms of increased PVR
time frame: 12 months after Fontan operation
description: facial edema plural effusion pericardium effusion
measure: WHO functional class
time frame: 12 months after Fontan operation
arm group label: Bosentan group
arm group type: Experimental
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 group label: Routinely group
arm group type: No Intervention
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: Bosentan
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 group label: Bosentan group
other name: Tracleer
criteria: 
gender: All
minimum age: 4 Months
maximum age: 18 Years
healthy volunteers: No
last name: Zhuoming Xu, MD PhD
role: Study Director
affiliation: Cardiac intensive care unit, Department of Thoracic and cardiovascular Surgery, Shanghai children's Medical Center
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Limin Zhu
investigator title: Attendant doctor, Department of thoracic and cardiovascular surgery
mesh term: Heart Defects, Congenital
mesh term: Univentricular Heart
mesh term: Bosentan