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/NCT05969925</url>
    </required_header>
    <id_info>
      <org_study_id>Ahmed Mahny</org_study_id>
      <nct_id>NCT05969925</nct_id>
    </id_info>
    <brief_title>Biomarkers of Pediatric Heart Failure</brief_title>
    <official_title>Study of Some Biomarkers Of Heart Failure In Children Attending Pediatric Cardiology Department Of Assiut University Children Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ahmed Ali Mahny</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Assiut University</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>
        Heart failure (HF) is a clinical syndrome where the heart is unable to pump the blood&#xD;
        required to meet the metabolic demands of the body. Heart failure in children can result from&#xD;
        a variety of structural or functional cardiac disorders with subsequent failure of the&#xD;
        ventricles to fill with or eject blood&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiac biomarkers are useful as diagnostic and prognostic tools, especially in patients with&#xD;
        atypical signs and symptoms. High rate of complication in HF led to the search for suitable&#xD;
        cardiac biomarker that diagnose heart failure as early as possible, predict outcome, reflect&#xD;
        response to treatment and help in staging of heart failure and determine risk (6) . In&#xD;
        pediatrics, biomarkers of heart failure are particularly important for the early&#xD;
        identification and risk stratification of patients with systemic diseases and associated risk&#xD;
        for early development of heart failure. Good biomarkers have the following characteristics:&#xD;
        high sensitivity and specificity, the possibility of simultaneous processing of many samples,&#xD;
        short analysis time, low cost, and good clinical applications, thus predicting the risk of&#xD;
        heart failure and the associated prognosis as well as the adequacy of monitoring [7].&#xD;
  &#xD;
        . Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 kDa protein covalently bound to&#xD;
        matrix metalloproteinase-9 which was first isolated from neutrophils. It belongs to the&#xD;
        lipocalin family, NGAL has been found to be elevated in both plasma and urine in patients&#xD;
        with HF.(8) NGAL also acts as a growth and differentiation factor in the renal epithelium&#xD;
        [9].&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 2, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2, 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>serum level of Neutrophil gelatinase-associated lipocalin in pediatric heart failure</measure>
      <time_frame>one year</time_frame>
      <description>accuarcy of serum level of Neutrophil gelatinase-associated lipocalin in heart failure</description>
    </primary_outcome>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Heart Failure</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>new biomarkers for heart failure</intervention_name>
      <description>assess efficacy of new biomarkers for heart failure</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study will be carried out in the children diagnosed with heart failure (HF) will be&#xD;
          enrolled in this study. They will be choosen from those admitted at the Pediatric&#xD;
          Cardiology Unit, Pediatric Department, Assiut University Children's Hospital in one year&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria Children from 1 month to 16 years old admitted to Assiut children&#xD;
          University Hospital the Pediatric Cardiology unit with clinical manifestation of heart&#xD;
          failure according to Ross classification either due to congenital or due to acquired heart&#xD;
          disease will be enrolled in the study Exclusion Criteria Children with renal disease or&#xD;
          failure, hepatic disease, pulmonary diseases will also excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>16 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Ahmed A Moahmmed, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ahmed A Mohammed, Dr.</last_name>
      <phone>+18677791</phone>
      <email>ahmedna1712@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Watanabe K, Shih R. Update of Pediatric Heart Failure. Pediatr Clin North Am. 2020 Oct;67(5):889-901. doi: 10.1016/j.pcl.2020.06.004. Epub 2020 Aug 11.</citation>
      <PMID>32888688</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Ahmed Ali Mahny</investigator_full_name>
      <investigator_title>Specialist, Pediatric Hospital</investigator_title>
    </responsible_party>
    <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>Undecided</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/NCT05969925
  org study id: Ahmed Mahny
  nct id: NCT05969925
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Heart failure (HF) is a clinical syndrome where the heart is unable to pump the blood
        required to meet the metabolic demands of the body. Heart failure in children can result from
        a variety of structural or functional cardiac disorders with subsequent failure of the
        ventricles to fill with or eject blood
  Cardiac biomarkers are useful as diagnostic and prognostic tools, especially in patients with
        atypical signs and symptoms. High rate of complication in HF led to the search for suitable
        cardiac biomarker that diagnose heart failure as early as possible, predict outcome, reflect
        response to treatment and help in staging of heart failure and determine risk (6) . In
        pediatrics, biomarkers of heart failure are particularly important for the early
        identification and risk stratification of patients with systemic diseases and associated risk
        for early development of heart failure. Good biomarkers have the following characteristics:
        high sensitivity and specificity, the possibility of simultaneous processing of many samples,
        short analysis time, low cost, and good clinical applications, thus predicting the risk of
        heart failure and the associated prognosis as well as the adequacy of monitoring [7].
  
        . Neutrophil gelatinase-associated lipocalin (NGAL) is a 25 kDa protein covalently bound to
        matrix metalloproteinase-9 which was first isolated from neutrophils. It belongs to the
        lipocalin family, NGAL has been found to be elevated in both plasma and urine in patients
        with HF.(8) NGAL also acts as a growth and differentiation factor in the renal epithelium
        [9].
  observational model: Cohort
  time perspective: Prospective
  measure: serum level of Neutrophil gelatinase-associated lipocalin in pediatric heart failure
  time frame: one year
  description: accuarcy of serum level of Neutrophil gelatinase-associated lipocalin in heart failure
  intervention type: Diagnostic Test
  intervention name: new biomarkers for heart failure
  description: assess efficacy of new biomarkers for heart failure
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 16 Years
  last name: Ahmed A Moahmmed, Dr.
  role: Principal Investigator
  affiliation: Assiut University
  last name: Ahmed A Mohammed, Dr.
  phone: +18677791
  email: ahmedna1712@gmail.com
  citation: Watanabe K, Shih R. Update of Pediatric Heart Failure. Pediatr Clin North Am. 2020 Oct;67(5):889-901. doi: 10.1016/j.pcl.2020.06.004. Epub 2020 Aug 11.
  PMID: 32888688
  responsible party type: Sponsor-Investigator
  investigator affiliation: Assiut University
  investigator full name: Ahmed Ali Mahny
  investigator title: Specialist, Pediatric Hospital
  mesh term: Heart Failure
  sharing ipd: Undecided