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/NCT06037434</url>
    </required_header>
    <id_info>
      <org_study_id>2022-GSP-GG-19-1</org_study_id>
      <nct_id>NCT06037434</nct_id>
    </id_info>
    <brief_title>Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation</brief_title>
    <official_title>A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Drug Therapy for Pediatric Mitral Regurgitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanghai Children's Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chinese Academy of Medical Sciences, Fuwai Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Guangzhou Women and Children's Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Children's Hospital of Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Fuwai Central China Cardiovascular Hospital, Zhengzhou, China</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>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to compare the safety and effectiveness of a modified&#xD;
        drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral&#xD;
        valve regurgitation.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Can a modified drug therapy improve both left ventricular and mitral valve function in&#xD;
             pediatric patients with mild to moderate mitral valve regurgitation?&#xD;
  &#xD;
          -  Can the adverse drug reactions caused by the modified drug therapy be non-inferior&#xD;
             (clinically acceptable) to those of the traditional drug therapy? Participants will be&#xD;
             assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting&#xD;
             enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and&#xD;
             spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium&#xD;
             supplements) based on personal preferences and clinical assessments by their attending&#xD;
             physicians. They will undergo a one-year course of medication. Additionally,&#xD;
             echocardiography, electrocardiograms, complete blood counts, biochemical tests, and&#xD;
             measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted&#xD;
             before the initiation of medication therapy and at 3 months, 6 months, and 12 months&#xD;
             after treatment commencement.&#xD;
  &#xD;
        Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy&#xD;
        Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as&#xD;
        assessed by echocardiography after 12 months of treatment, is lower in the former than in the&#xD;
        latter.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 9, 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>12 Months</target_duration>
    <primary_outcome>
      <measure>the recurrence rate of moderate to severe mitral valve regurgitation</measure>
      <time_frame>after 12 months of treatment</time_frame>
      <description>During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Improvement in symptoms</measure>
      <time_frame>after 12 months of treatment</time_frame>
      <description>Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in left ventricular ejection fraction</measure>
      <time_frame>after 12 months of treatment</time_frame>
      <description>Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in left ventricular end-diastolic diameter</measure>
      <time_frame>after 12 months of treatment</time_frame>
      <description>Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NT-proBNP level</measure>
      <time_frame>after 12 months of treatment</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 12 months of treatment</time_frame>
      <description>The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">122</enrollment>
    <condition>Congenital Mitral Insufficiency</condition>
    <arm_group>
      <arm_group_label>Modified Drug Therapy Group</arm_group_label>
      <description>Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>the Traditional Drug Therapy Group</arm_group_label>
      <description>Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Captopril Tablets</intervention_name>
      <description>0.3mg/kg, tid</description>
      <arm_group_label>Modified Drug Therapy Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Metoprolol Oral Tablet</intervention_name>
      <description>0.2mg/kg, bid</description>
      <arm_group_label>Modified Drug Therapy Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Spironolactone Tablets</intervention_name>
      <description>2-4mg/kg, bid</description>
      <arm_group_label>Modified Drug Therapy Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Torsemide Tablets</intervention_name>
      <description>0.2-0.5mg/mg, bid</description>
      <arm_group_label>Modified Drug Therapy Group</arm_group_label>
      <arm_group_label>the Traditional Drug Therapy Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Potassium citrate powder</intervention_name>
      <description>0.06g/kg, tid</description>
      <arm_group_label>Modified Drug Therapy Group</arm_group_label>
      <arm_group_label>the Traditional Drug Therapy Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children under the age of 14 with moderate to severe mitral valve regurgitation, without&#xD;
          contraindications for mitral valve repair, and without an immediate need for surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  &lt; 14 years old&#xD;
  &#xD;
            -  had not undertake mitral valve surgery before&#xD;
  &#xD;
            -  moderate to severe mitral regurgitation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  moderate to severe mitral regurgitation which concommitant with other cardiac&#xD;
               malformation which can not be correct or can only perform palliative surgery&#xD;
  &#xD;
            -  concommitant with mitral stenosis&#xD;
  &#xD;
            -  ischemic mitral regurgitation (for example, concommitant with anomalous origin of&#xD;
               coronary artery)&#xD;
  &#xD;
            -  Barlow syndrome&#xD;
  &#xD;
            -  dysplasia of mitral leaflet&#xD;
  &#xD;
            -  complete/Partial endocardial cushion defect&#xD;
  &#xD;
            -  common atrioventricular valve&#xD;
  &#xD;
            -  atrioventricular common channel&#xD;
  &#xD;
            -  cardiomyopathy&#xD;
  &#xD;
            -  other mitral valve surgery contraindications&#xD;
  &#xD;
            -  moderate to severe mitral regurgitation requires mitral valve surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </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 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 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>mitral regurgitation</keyword>
    <keyword>drug therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mitral Valve Insufficiency</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metoprolol</mesh_term>
      <mesh_term>Captopril</mesh_term>
      <mesh_term>Torsemide</mesh_term>
      <mesh_term>Spironolactone</mesh_term>
      <mesh_term>Potassium Citrate</mesh_term>
    </intervention_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/NCT06037434
  org study id: 2022-GSP-GG-19-1
  nct id: NCT06037434
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this observational study is to compare the safety and effectiveness of a modified
        drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral
        valve regurgitation.
  
        The main questions it aims to answer are:
  
          -  Can a modified drug therapy improve both left ventricular and mitral valve function in
             pediatric patients with mild to moderate mitral valve regurgitation?
  
          -  Can the adverse drug reactions caused by the modified drug therapy be non-inferior
             (clinically acceptable) to those of the traditional drug therapy? Participants will be
             assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting
             enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and
             spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium
             supplements) based on personal preferences and clinical assessments by their attending
             physicians. They will undergo a one-year course of medication. Additionally,
             echocardiography, electrocardiograms, complete blood counts, biochemical tests, and
             measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted
             before the initiation of medication therapy and at 3 months, 6 months, and 12 months
             after treatment commencement.
  
        Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy
        Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as
        assessed by echocardiography after 12 months of treatment, is lower in the former than in the
        latter.
  observational model: Cohort
  time perspective: Prospective
  measure: the recurrence rate of moderate to severe mitral valve regurgitation
  time frame: after 12 months of treatment
  description: During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.
  measure: Improvement in symptoms
  time frame: after 12 months of treatment
  description: Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.
  measure: Change in left ventricular ejection fraction
  time frame: after 12 months of treatment
  description: Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.
  measure: Change in left ventricular end-diastolic diameter
  time frame: after 12 months of treatment
  description: Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.
  measure: NT-proBNP level
  time frame: after 12 months of treatment
  description: The trend in NT-proBNP levels.
  measure: Incidence rate of drug adverse reactions
  time frame: after 12 months of treatment
  description: The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
  arm group label: Modified Drug Therapy Group
  description: Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).
  arm group label: the Traditional Drug Therapy Group
  description: Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).
  intervention type: Drug
  intervention name: Captopril Tablets
  description: 0.3mg/kg, tid
  arm group label: Modified Drug Therapy Group
  intervention type: Drug
  intervention name: Metoprolol Oral Tablet
  description: 0.2mg/kg, bid
  arm group label: Modified Drug Therapy Group
  intervention type: Drug
  intervention name: Spironolactone Tablets
  description: 2-4mg/kg, bid
  arm group label: Modified Drug Therapy Group
  intervention type: Drug
  intervention name: Torsemide Tablets
  description: 0.2-0.5mg/mg, bid
  arm group label: Modified Drug Therapy Group
  arm group label: the Traditional Drug Therapy Group
  intervention type: Drug
  intervention name: Potassium citrate powder
  description: 0.06g/kg, tid
  arm group label: Modified Drug Therapy Group
  arm group label: the Traditional Drug Therapy Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 14 Years
  healthy volunteers: No
  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: Mitral Valve Insufficiency
  mesh term: Metoprolol
  mesh term: Captopril
  mesh term: Torsemide
  mesh term: Spironolactone
  mesh term: Potassium Citrate
  sharing ipd: No