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/NCT06039540</url>
    </required_header>
    <id_info>
      <org_study_id>2022-1-4032-1</org_study_id>
      <nct_id>NCT06039540</nct_id>
    </id_info>
    <brief_title>Study of Drug Therapy for Pediatric Heart Failure</brief_title>
    <official_title>A Comprehensive Research of Pediatric Heart Failure--A Prospective Cohort Study of Drug Therapy for 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>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 heart failure patients.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Can a modified drug therapy improve left ventricular function in pediatric heart failure&#xD;
             patients?&#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 6-months 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 1 month, 3 months, and 6 months after&#xD;
             treatment commencement. Researchers will compare the Modified Drug Therapy Group and the&#xD;
             Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe&#xD;
             mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment,&#xD;
             is lower in the former than in the latter.&#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">June 22, 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 treatment</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 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 6 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>
    <secondary_outcome>
      <measure>Readmission rate for heart failure</measure>
      <time_frame>after 6 months of treatment</time_frame>
      <description>During follow-up visits, readmission for heart failure will be recorded.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Heart Failure Congenital</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).e Traditional Drug Therapy Group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>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>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>Traditional Drug Therapy Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          paitent younger than 14 years of age with heart failure after suergry congenital heart&#xD;
          disease&#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;
            -  heart failure after congenital heart surgery&#xD;
  &#xD;
            -  Ross &gt; 2 or NYHA &gt; 2&#xD;
  &#xD;
            -  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 failure</keyword>
    <keyword>drug therapy</keyword>
    <keyword>congenital heart disease postoperative</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</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/NCT06039540
  org study id: 2022-1-4032-1
  nct id: NCT06039540
  lead sponsor: 
  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 heart failure patients.
  
        The main questions it aims to answer are:
  
          -  Can a modified drug therapy improve left ventricular function in pediatric heart failure
             patients?
  
          -  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 6-months 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 1 month, 3 months, and 6 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 6 months of treatment,
             is lower in the former than in the latter.
  observational model: Cohort
  time perspective: Prospective
  measure: the recurrence rate of heart failure
  time frame: after 6 months of treatment
  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 treatment
  description: The trend in NT-proBNP levels.
  measure: Incidence rate of drug adverse reactions
  time frame: after 6 months of treatment
  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 treatment
  description: During follow-up visits, readmission for heart failure will be recorded.
  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).e Traditional Drug Therapy Group
  arm group label: 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: 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: Traditional Drug Therapy 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
  mesh term: Metoprolol
  mesh term: Captopril
  mesh term: Torsemide
  mesh term: Spironolactone
  mesh term: Potassium Citrate
  sharing ipd: No