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/NCT06039969</url>
    </required_header>
    <id_info>
      <org_study_id>20230911</org_study_id>
      <nct_id>NCT06039969</nct_id>
    </id_info>
    <brief_title>Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.</brief_title>
    <official_title>Study on the Changes of Intestinal Flora and Cardiac Fibrosis in Patients With Dilated Cardiomyopathy Diagnosed for the First Time by Sports Rehabilitation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing Medical University</source>
    <brief_summary>
      <textblock>
        To invegstive the Changes of Intestinal Flora and the improvements of Cardiac Fibrosis in&#xD;
        Patients With Dilated Cardiomyopathy Diagnosed for the First Time by heart Rehabilitation&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Previous studies have confirmed that Aerobic exercise rehabilitation can reduce the rate of&#xD;
        readmission of patients with heart failure and improve their cardiopulmonary endurance and&#xD;
        exercise ability. However, whether aerobic exercise rehabilitation can inhibit myocardial&#xD;
        fibrosis or delay the progress of fibrosis in patients with heart failure has not been&#xD;
        reported. At the same time, some studies have shown that the change of intestinal microbial&#xD;
        flora may promote the progress of heart failure, and regular aerobic exercise will also lead&#xD;
        to the change of intestinal microbial flora, but whether aerobic exercise rehabilitation can&#xD;
        improve intestinal microbial flora in patients with dilated cardiomyopathy has not been&#xD;
        reported. In our study, patients who were hospitalized for heart failure for the first time&#xD;
        and were finally diagnosed with dilated cardiomyopathy were recruited. Recruited patients&#xD;
        will enter the routine cardiac rehabilitation process and make an individualized aerobic&#xD;
        exercise plan according to the cardiopulmonary exercise test. Cardiac MRI and intestinal&#xD;
        microflora changes will be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>myocardial fibrosis</measure>
      <time_frame>first admission six months one year</time_frame>
      <description>Assessment of myocardial fibrosis based on cardiac MRI examination</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bacterial spectrum of intestine</measure>
      <time_frame>first admission six months one year</time_frame>
      <description>Assessment of Bacterial spectrum of intestine based on Patient feces sequencing</description>
    </secondary_outcome>
    <other_outcome>
      <measure>cardiac fitiness</measure>
      <time_frame>first admission six months one year</time_frame>
      <description>Assessment of caridac fitness based on ardiopulmonary exercise test</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Cardiac Rehabilitation</condition>
    <condition>Myocardial Fibrosis</condition>
    <arm_group>
      <arm_group_label>Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy.</arm_group_label>
      <description>Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy. At the same time Collect patient feces.this is a obvertional study ,ther is no intervetion</description>
    </arm_group>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Cardiac MRI data and patient's feces will be collected.Changes in intestinal flora spectrum&#xD;
        will be detected.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          patients who were hospitalized for heart failure for the first time and were finally&#xD;
          diagnosed with dilated cardiomyopathy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1、Patients hospitalized for the first time because of heart failure 2、The patient who&#xD;
               was definitely diagnosed as dilated cardiomyopathy for the first time&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1、Other types of cardiomyopathy 2、Has been diagnosed as dilated cardiomyopathy.&#xD;
               3、malignant tumor 4、acute infection 5、Cannot perform cardiopulmonary exercise test.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>XiWen Zhang, MD</last_name>
      <role>Study Director</role>
      <affiliation>Huai'an First People's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jin Geng, MD</last_name>
      <phone>+86-17753124846</phone>
      <email>gj885258@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>XiWen Zhang, MD</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Huai'An First People'S Hospital</name>
        <address>
          <city>Huai'an</city>
          <state>Jiangsu</state>
          <zip>223300</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaozhong Yang, MD</last_name>
      </contact>
      <investigator>
        <last_name>Hailang Liu, MM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 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>Nanjing Medical University</investigator_affiliation>
      <investigator_full_name>Jin Geng</investigator_full_name>
      <investigator_title>associate doctor</investigator_title>
    </responsible_party>
    <keyword>Aerobic exercise rehabilitation</keyword>
    <keyword>Myocardial Fibrosis</keyword>
    <keyword>human gut microbiome</keyword>
    <keyword>cardiac magnetic resonance</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cardiomyopathies</mesh_term>
      <mesh_term>Cardiomyopathy, Dilated</mesh_term>
      <mesh_term>Fibrosis</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/NCT06039969
  org study id: 20230911
  nct id: NCT06039969
  lead sponsor: 
  To invegstive the Changes of Intestinal Flora and the improvements of Cardiac Fibrosis in
        Patients With Dilated Cardiomyopathy Diagnosed for the First Time by heart Rehabilitation
  Previous studies have confirmed that Aerobic exercise rehabilitation can reduce the rate of
        readmission of patients with heart failure and improve their cardiopulmonary endurance and
        exercise ability. However, whether aerobic exercise rehabilitation can inhibit myocardial
        fibrosis or delay the progress of fibrosis in patients with heart failure has not been
        reported. At the same time, some studies have shown that the change of intestinal microbial
        flora may promote the progress of heart failure, and regular aerobic exercise will also lead
        to the change of intestinal microbial flora, but whether aerobic exercise rehabilitation can
        improve intestinal microbial flora in patients with dilated cardiomyopathy has not been
        reported. In our study, patients who were hospitalized for heart failure for the first time
        and were finally diagnosed with dilated cardiomyopathy were recruited. Recruited patients
        will enter the routine cardiac rehabilitation process and make an individualized aerobic
        exercise plan according to the cardiopulmonary exercise test. Cardiac MRI and intestinal
        microflora changes will be evaluated.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: myocardial fibrosis
  time frame: first admission six months one year
  description: Assessment of myocardial fibrosis based on cardiac MRI examination
  measure: Bacterial spectrum of intestine
  time frame: first admission six months one year
  description: Assessment of Bacterial spectrum of intestine based on Patient feces sequencing
  measure: cardiac fitiness
  time frame: first admission six months one year
  description: Assessment of caridac fitness based on ardiopulmonary exercise test
  arm group label: Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy.
  description: Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy. At the same time Collect patient feces.this is a obvertional study ,ther is no intervetion
  Cardiac MRI data and patient's feces will be collected.Changes in intestinal flora spectrum
        will be detected.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: XiWen Zhang, MD
  role: Study Director
  affiliation: Huai'an First People's Hospital
  last name: Jin Geng, MD
  phone: +86-17753124846
  email: gj885258@163.com
  last name: XiWen Zhang, MD
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Nanjing Medical University
  investigator full name: Jin Geng
  investigator title: associate doctor
  mesh term: Cardiomyopathies
  mesh term: Cardiomyopathy, Dilated
  mesh term: Fibrosis
  sharing ipd: No