xml: <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/NCT06039553</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1-4032-2</org_study_id>
      <nct_id>NCT06039553</nct_id>
    </id_info>
    <brief_title>Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure</brief_title>
    <official_title>A Comprehensive Research of Pediatric Heart Failure -- A Self-control Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Children's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about the safety and effectiveness of&#xD;
        pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Can PAB therapy improve left ventricular(LV) function in PHF patients especially&#xD;
             refractory PHF.&#xD;
  &#xD;
          -  Can the complications caused by the PAB therapy be clinically acceptable? Participants&#xD;
             underwent PAB therapy will be required to underwent echocardiography,&#xD;
             electrocardiograms, complete blood counts, biochemical tests, and measurements of&#xD;
             N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of&#xD;
             PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare&#xD;
             the LV function 6 months after PAB suergey and the preoperative ones to see if there is&#xD;
             improvement.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>the recurrence rate of heart failure</measure>
      <time_frame>after 6 months of PAB surgery</time_frame>
      <description>During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>NT-proBNP level</measure>
      <time_frame>after 6 months of PAB surgery</time_frame>
      <description>The trend in NT-proBNP levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence rate of drug adverse reactions</measure>
      <time_frame>after 6 months of PAB surgery</time_frame>
      <description>The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission rate for heart failure</measure>
      <time_frame>after 6 months of PAB surgery</time_frame>
      <description>During follow-up visits, readmission for heart failure will be recorded.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Heart Failure Congenital</condition>
    <arm_group>
      <arm_group_label>Pulmonary Artery Banding Group</arm_group_label>
      <description>Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>pulmonary artery banding</intervention_name>
      <description>Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.</description>
      <arm_group_label>Pulmonary Artery Banding Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          paitent younger than 14 years of age with heart failure&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients younger than 14 years of age&#xD;
  &#xD;
            -  congenital heart failure (LVEF&lt;55%, or LVFS&lt;25%)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  single ventricle&#xD;
  &#xD;
            -  congenital heart disease without anatomical correction&#xD;
  &#xD;
            -  Patients with heart failure requiring ventricular assist or cardiac synchronization&#xD;
               therapy&#xD;
  &#xD;
            -  Patients with severe pulmonary hypertension (pulmonary arterial pressure &gt;6 Wood·U)&#xD;
  &#xD;
            -  Patients with severe liver and kidney failure&#xD;
  &#xD;
            -  Patients who are allergic to related medications&#xD;
  &#xD;
            -  Patients with symptomatic hypotension who cannot tolerate related drugs&#xD;
  &#xD;
            -  Refuse to sign the informed consent or refuse to participate in this experiment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>14 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Shoujun Li, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Fuwai Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kai Ma, PhD</last_name>
      <phone>+86 15901428497</phone>
      <email>drmakaifw@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zheng Dou, PhD</last_name>
      <phone>+86 18810673618</phone>
      <email>drdouzheng@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fuwai hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shoujun Li, MD</last_name>
        <phone>+86 13501071589</phone>
        <email>drlishoujunfw@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
      <investigator_full_name>Shoujun Li</investigator_full_name>
      <investigator_title>Director of Congenital Heart Surgery Center</investigator_title>
    </responsible_party>
    <keyword>congenital heart disease</keyword>
    <keyword>pulmonary artery banding</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039553
  org study id: 2022-1-4032-2
  nct id: NCT06039553
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the safety and effectiveness of
        pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients.
  
        The main questions it aims to answer are:
  
          -  Can PAB therapy improve left ventricular(LV) function in PHF patients especially
             refractory PHF.
  
          -  Can the complications caused by the PAB therapy be clinically acceptable? Participants
             underwent PAB therapy will be required to underwent echocardiography,
             electrocardiograms, complete blood counts, biochemical tests, and measurements of
             N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of
             PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare
             the LV function 6 months after PAB suergey and the preoperative ones to see if there is
             improvement.
  observational model: Cohort
  time perspective: Prospective
  measure: the recurrence rate of heart failure
  time frame: after 6 months of PAB surgery
  description: During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence.
  measure: NT-proBNP level
  time frame: after 6 months of PAB surgery
  description: The trend in NT-proBNP levels.
  measure: Incidence rate of drug adverse reactions
  time frame: after 6 months of PAB surgery
  description: The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
  measure: Readmission rate for heart failure
  time frame: after 6 months of PAB surgery
  description: During follow-up visits, readmission for heart failure will be recorded.
  arm group label: Pulmonary Artery Banding Group
  description: Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
  intervention type: Procedure
  intervention name: pulmonary artery banding
  description: Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
  arm group label: Pulmonary Artery Banding Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 14 Years
  last name: Shoujun Li, MD
  role: Study Chair
  affiliation: Fuwai Hospital
  last name: Kai Ma, PhD
  phone: +86 15901428497
  email: drmakaifw@yahoo.com
  last name: Zheng Dou, PhD
  phone: +86 18810673618
  email: drdouzheng@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: China National Center for Cardiovascular Diseases
  investigator full name: Shoujun Li
  investigator title: Director of Congenital Heart Surgery Center
  mesh term: Heart Failure
  sharing ipd: No