<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/NCT03754101</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-DM-GENE</org_study_id>
    <nct_id>NCT03754101</nct_id>
  </id_info>
  <brief_title>Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants</brief_title>
  <official_title>Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji 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>
      Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the&#xD;
      present study, we intend to identify new related variants or genes. From March, 2003 to&#xD;
      November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their&#xD;
      sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole&#xD;
      exome sequencing was used to find out the variants associated with the onset of&#xD;
      cardiomyopathy and its prognosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 3, 2003</start_date>
  <completion_date type="Anticipated">October 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>Cardiovascular death confirmed by death comfirmation or interview with the relatives</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Death from cardiovascular causes and any unknown death unless there was another certain cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart transplantation confirmed by medical record</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Heart transplantation within 24 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause death confirmed by death comfirmation or interview with the relatives</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Any death at hospital or after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart failure recurring confirmed by medical record</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Recurrence of heart failure at hospital or after discharge</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Readmission because of cardiovascular diseases confirmed by medical record</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Readmission because of cardiovascular diseases within 24 months</description>
  </other_outcome>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Cardiomyopathy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        hospitalized patients with cardiomyopathy will be enrolled in this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        · Patients diagnosed as cardiomyopathy according to the definition of American Heart&#xD;
        Association&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension significant valvular disease&#xD;
&#xD;
          -  Mild ischemic heart disease&#xD;
&#xD;
          -  Significant systemic infection&#xD;
&#xD;
          -  Thyroid-induced cardiomyopathy&#xD;
&#xD;
          -  Excessive alcohol consumption&#xD;
&#xD;
          -  Precious cancer treatment including irradiation&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dao Wen Wang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji Hospital,Wuhan, Hubei, China, 430030</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chenze Li, MD candidate</last_name>
    <phone>86-27-83663280</phone>
    <email>lichenze@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chenze Li, MD candidate</last_name>
      <phone>86-27-83663280</phone>
      <email>lichenze@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 1, 2018</study_first_submitted>
  <study_first_submitted_qc>November 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Dao Wen Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03754101
org study id: TJ-DM-GENE
nct id: NCT03754101
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the
      present study, we intend to identify new related variants or genes. From March, 2003 to
      November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their
      sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole
      exome sequencing was used to find out the variants associated with the onset of
      cardiomyopathy and its prognosis.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular death confirmed by death comfirmation or interview with the relatives
time frame: up to 24 months
description: Death from cardiovascular causes and any unknown death unless there was another certain cause
measure: Heart transplantation confirmed by medical record
time frame: up to 24 months
description: Heart transplantation within 24 months
measure: All cause death confirmed by death comfirmation or interview with the relatives
time frame: up to 24 months
description: Any death at hospital or after discharge
measure: Heart failure recurring confirmed by medical record
time frame: up to 24 months
description: Recurrence of heart failure at hospital or after discharge
measure: Readmission because of cardiovascular diseases confirmed by medical record
time frame: up to 24 months
description: Readmission because of cardiovascular diseases within 24 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dao Wen Wang, Doctor
role: Study Chair
affiliation: Tongji Hospital,Wuhan, Hubei, China, 430030
last name: Chenze Li, MD candidate
phone: 86-27-83663280
email: lichenze@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Dao Wen Wang
investigator title: Professor
mesh term: Cardiomyopathies
sharing ipd: Undecided