<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/NCT03011697</url>
  </required_header>
  <id_info>
    <org_study_id>SAHZJU CT010</org_study_id>
    <nct_id>NCT03011697</nct_id>
  </id_info>
  <brief_title>Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University</brief_title>
  <acronym>VHD-ZJU</acronym>
  <official_title>A Prospective, Single-center,Registry Study of Chinese Hospitalized Adult Patients With Valvular Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We design a prospective, observational cohort study to provide contemporary information on&#xD;
      the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis&#xD;
      of Chinese hospitalised adult patients with valvular heart disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has&#xD;
      brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart&#xD;
      disease are not so clear, especially in the developing countries such as China etc. Because&#xD;
      of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed&#xD;
      on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular&#xD;
      diseases are very common in China. Hence, we design a prospective, observational cohort study&#xD;
      to provide contemporary information on the prevalence, characteristics, risk&#xD;
      stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult&#xD;
      patients with valvular heart disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</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>All-cause mortality and disabling strokes</measure>
    <time_frame>one year</time_frame>
    <description>All-cause mortality and disabling strokes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for heart failure</measure>
    <time_frame>one year</time_frame>
    <description>Hospitalization for heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical or transcatheter aortic valve replacement</measure>
    <time_frame>one year</time_frame>
    <description>Surgical or transcatheter aortic valve replacement</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Valvular Heart Disease</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        10000 hospitalized patients over 18 years old with valvular heart disease will be enrolled&#xD;
        consecutively&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Hospitalized patients over 18 years old meet one of the following conditions.&#xD;
&#xD;
          1. moderate or above valvular heart disease as defined by echocardiography: 1.1 Aortic&#xD;
             stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec,&#xD;
             or mean pressure gradient ≥20mmHg, 1.2 Aortic regurgitation, moderate or above, or jet&#xD;
             width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or&#xD;
             regurgitant fraction ≥30%, 1.3 Mitral stenosis, moderate or above, or valve area&#xD;
             ≤2.0cm2, 1.4 Mitral regurgitation, moderate or above, or effective regurgitant orifice&#xD;
             ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, 1.5 Tricuspid&#xD;
             stenosis, moderate or above, or valve area ≤1.0cm2, 1.6 Tricuspid regurgitation,&#xD;
             moderate or above, or central jet area ≥5.0cm2, 1.7 Pulmonic stenosis, moderate or&#xD;
             above, or maximal jet velocity &gt;4m/sec, 1.8 Pulmonic regurgitation, moderate or above,&#xD;
&#xD;
          2. Patients who had undergone any operation on a cardiac valve (percutaneous balloon&#xD;
             commissurotomy, valve repair, valve replacement, transcatheter aortic valve&#xD;
             implantation),&#xD;
&#xD;
          3. Diagnosis of endocarditis as assessed by Duke criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients cannot be followed up for any reasons.&#xD;
&#xD;
          2. Patients in critical condition may be die in one year.&#xD;
&#xD;
          3. Patients have been enrolled in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wang Jian-an, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital Zhejiang University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liu Xianbao, MD</last_name>
    <phone>+86-13857173887</phone>
    <email>liuxb2009@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wang Jian-an, MD,PhD</last_name>
    <phone>+86-13805786328</phone>
    <email>jian_an_wang@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>2nd Affiliated Hospital, School of Medicine at Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liu Xianbao, MD</last_name>
      <phone>+86-13857173887</phone>
      <email>liuxb2009@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Wang Jian-an, MD,PhD</last_name>
      <phone>+86-13805786328</phone>
      <email>jian_an_wang@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Wang Jian-an, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27908608</url>
    <description>hospital-based survey of patients with severe valvular heart disease in China</description>
  </link>
  <reference>
    <citation>Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.</citation>
    <PMID>27908608</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>Jian'an Wang,MD,PhD</investigator_full_name>
    <investigator_title>President of Second Affiliated Hospital, School of Medicine, Zhejiang University &amp; Chief of Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Valve Diseases</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/NCT03011697
org study id: SAHZJU CT010
nct id: NCT03011697
lead sponsor: 
has dmc: Yes
We design a prospective, observational cohort study to provide contemporary information on
      the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis
      of Chinese hospitalised adult patients with valvular heart disease.
Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has
      brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart
      disease are not so clear, especially in the developing countries such as China etc. Because
      of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed
      on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular
      diseases are very common in China. Hence, we design a prospective, observational cohort study
      to provide contemporary information on the prevalence, characteristics, risk
      stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult
      patients with valvular heart disease.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality and disabling strokes
time frame: one year
description: All-cause mortality and disabling strokes
measure: Hospitalization for heart failure
time frame: one year
description: Hospitalization for heart failure
measure: Surgical or transcatheter aortic valve replacement
time frame: one year
description: Surgical or transcatheter aortic valve replacement
Peripheral blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wang Jian-an, MD,PhD
role: Principal Investigator
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
last name: Liu Xianbao, MD
phone: +86-13857173887
email: liuxb2009@hotmail.com
last name: Wang Jian-an, MD,PhD
phone: +86-13805786328
email: jian_an_wang@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
url: http://www.ncbi.nlm.nih.gov/pubmed/27908608
description: hospital-based survey of patients with severe valvular heart disease in China
citation: Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.
PMID: 27908608
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: Jian'an Wang,MD,PhD
investigator title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
mesh term: Heart Diseases
mesh term: Heart Valve Diseases