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/NCT06006819</url>
    </required_header>
    <id_info>
      <org_study_id>CHGH(983)111A-61</org_study_id>
      <nct_id>NCT06006819</nct_id>
    </id_info>
    <brief_title>Prognostic Markers of Acute Heart Failure With Chronic Kidney Disease</brief_title>
    <official_title>Plasma Proteomic Signature and the Prognosis of Acute Heart Failure With or Without Chronic Kidney Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cheng-Hsin General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cheng-Hsin General Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart&#xD;
        failure and is the most frequent cause of unplanned hospital admission in elderly patients.&#xD;
        N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic&#xD;
        markers for AHR patients and. NT-pro-BNP has limitations in terms of diagnostic or predictive&#xD;
        accuracy in patients with chronic kidney disease (CKD). Plasma proteomics have the potential&#xD;
        to examine underlying pathophysiological and prognostic roles, so we compared the plasma&#xD;
        proteomic signature to predict outcomes of patients with or without CKD hospitalized for AHF.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 23, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 23, 2025</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>major adverse cardiovascular events</measure>
      <time_frame>1 year</time_frame>
      <description>mortality, acute myocardial infarction, acute stroke, and heart failure hospitalization</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>major adverse kidney events</measure>
      <time_frame>1 year</time_frame>
      <description>mortality, new end-stage renal disease, and 30% decline in estimated GFR</description>
    </secondary_outcome>
    <enrollment type="Anticipated">155</enrollment>
    <condition>Chronic Kidney Diseases</condition>
    <condition>Acute Heart Failure</condition>
    <condition>Biomarker</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Study participants were recruited from patients admitted to Cheng Hsin General Hospital&#xD;
          with the major diagnosis of acute heart failure. After written informed consent was&#xD;
          obtained (in compliance with the Helsinki Declaration), patients with age more than 20 were&#xD;
          included. Exclusion criteria were initial serum NT-proBNP level &lt;300ng/ml, the presence of&#xD;
          amputation, being pregnant, and receiving regular dialysis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  hospitalized for acute heart failure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  initial serum NT-proBNP level &lt;300ng/ml, pregnancy, amputated, and end-stage renal&#xD;
               disease under regular dialysis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shang Feng Yang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cheng-Hsin General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shang Feng Yang, MD</last_name>
      <phone>+886-22826-4400</phone>
      <phone_ext>2481</phone_ext>
      <email>samyang1223@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cheng Hsin General Hospital</name>
        <address>
          <city>Taipei</city>
          <state>Baitou District</state>
          <zip>112</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shang Feng Yang, MD</last_name>
        <phone>+886-22826-4400</phone>
        <phone_ext>2481</phone_ext>
        <email>samyang1223@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cheng-Hsin General Hospital</investigator_affiliation>
      <investigator_full_name>Shang Feng Yang</investigator_full_name>
      <investigator_title>Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
      <mesh_term>Heart Failure</mesh_term>
    </condition_browse>
    <!-- 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/NCT06006819
  org study id: CHGH(983)111A-61
  nct id: NCT06006819
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart
        failure and is the most frequent cause of unplanned hospital admission in elderly patients.
        N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic
        markers for AHR patients and. NT-pro-BNP has limitations in terms of diagnostic or predictive
        accuracy in patients with chronic kidney disease (CKD). Plasma proteomics have the potential
        to examine underlying pathophysiological and prognostic roles, so we compared the plasma
        proteomic signature to predict outcomes of patients with or without CKD hospitalized for AHF.
  observational model: Cohort
  time perspective: Prospective
  measure: major adverse cardiovascular events
  time frame: 1 year
  description: mortality, acute myocardial infarction, acute stroke, and heart failure hospitalization
  measure: major adverse kidney events
  time frame: 1 year
  description: mortality, new end-stage renal disease, and 30% decline in estimated GFR
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Shang Feng Yang, MD
  role: Principal Investigator
  affiliation: Cheng-Hsin General Hospital
  last name: Shang Feng Yang, MD
  phone: +886-22826-4400
  phone ext: 2481
  email: samyang1223@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Cheng-Hsin General Hospital
  investigator full name: Shang Feng Yang
  investigator title: Physician
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Heart Failure