<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/NCT03797742</url>
  </required_header>
  <id_info>
    <org_study_id>HF201801</org_study_id>
    <nct_id>NCT03797742</nct_id>
  </id_info>
  <brief_title>A Clinical Follow-up Study of Heart Failure Patients.</brief_title>
  <official_title>A Clinical Follow-up Study of Heart Failure Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan 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>
      Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity&#xD;
      and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by&#xD;
      progressive alteration of cardiac structure and function. But the molecular mechanism of&#xD;
      these alterations is still not well-established and needs to be discussed further. HF is a&#xD;
      highly heterogeneous disease that can be caused by a multiple of diseases. Dilated&#xD;
      cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome.&#xD;
      Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are&#xD;
      different. Understanding the different pathophysiological mechanisms will contribute to the&#xD;
      prevention and individualized therapy of heart failure. Therefore, this study aims to&#xD;
      observation the different characteristics of the molecular biology and clinical courses in&#xD;
      DCM and ICM patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NYHA functional class</measure>
    <time_frame>one year after enrolled</time_frame>
    <description>NYHA cardiac functional class</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>one year after enrolled</time_frame>
    <description>All-cause mortality during follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospitalization for cardiac causes</measure>
    <time_frame>one year after enrolled</time_frame>
    <description>hospitalization for cardiac causes during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricular end-diastolic dimension(LVEDD) dilates.</measure>
    <time_frame>one year after enrolled</time_frame>
    <description>left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricular ejection fraction reduces</measure>
    <time_frame>one year after enrolled</time_frame>
    <description>left ventricular function changes:left ventricular ejection fraction reduces</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>NC</arm_group_label>
    <description>Patients without heart failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DCM</arm_group_label>
    <description>Dilated cardiomyopathy patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICM</arm_group_label>
    <description>Ischemic cardiomyopathy patients.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum; Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will&#xD;
        be selected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LVEF≤ 55%&#xD;
&#xD;
          -  enlarged left ventricular end-diastolic dimension&#xD;
&#xD;
          -  ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal&#xD;
             LAD; ≥ 75% stenosis of two or more epicardial vessels.&#xD;
&#xD;
          -  symptomatic heart failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known malignant tumour diseases&#xD;
&#xD;
          -  Pregnancy or lactation period；&#xD;
&#xD;
          -  Investigators think not suitable to participate in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhangwei Chen</last_name>
    <phone>+86 021 64041990</phone>
    <email>chen.zhangwei@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhangwei Chen</last_name>
      <phone>+8602164041990</phone>
      <email>chen.zhangwei@zs-hospital.sh.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT03797742
org study id: HF201801
nct id: NCT03797742
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity
      and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by
      progressive alteration of cardiac structure and function. But the molecular mechanism of
      these alterations is still not well-established and needs to be discussed further. HF is a
      highly heterogeneous disease that can be caused by a multiple of diseases. Dilated
      cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome.
      Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are
      different. Understanding the different pathophysiological mechanisms will contribute to the
      prevention and individualized therapy of heart failure. Therefore, this study aims to
      observation the different characteristics of the molecular biology and clinical courses in
      DCM and ICM patients.
observational model: Case-Control
time perspective: Prospective
measure: NYHA functional class
time frame: one year after enrolled
description: NYHA cardiac functional class
measure: All-cause mortality
time frame: one year after enrolled
description: All-cause mortality during follow-up
measure: hospitalization for cardiac causes
time frame: one year after enrolled
description: hospitalization for cardiac causes during follow-up
measure: left ventricular end-diastolic dimension(LVEDD) dilates.
time frame: one year after enrolled
description: left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates.
measure: left ventricular ejection fraction reduces
time frame: one year after enrolled
description: left ventricular function changes:left ventricular ejection fraction reduces
arm group label: NC
description: Patients without heart failure.
arm group label: DCM
description: Dilated cardiomyopathy patients.
arm group label: ICM
description: Ischemic cardiomyopathy patients.
Serum; Whole blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhangwei Chen
phone: +86 021 64041990
email: chen.zhangwei@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure