<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/NCT03784833</url>
  </required_header>
  <id_info>
    <org_study_id>BIOMS-HF</org_study_id>
    <nct_id>NCT03784833</nct_id>
  </id_info>
  <brief_title>A Registry Study of Biomarkers in Heart Failure</brief_title>
  <acronym>BIOMS-HF</acronym>
  <official_title>A Registry Study of Biomarkers in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Institute of Heart, Lung and Blood Vessel Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tianjin Medical University Second Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Luhe Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Institute of Heart, Lung and Blood Vessel Diseases</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>
      The registry study aims to discover the prognostic value of bio-markers in heart failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to investigate the prognostic value of biomarkers in Heart&#xD;
      Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome&#xD;
      is all-cause mortality based on the death certificates. The secondary outcome is readmission&#xD;
      for heart failure and all-cause mortality/readmission for heart failure according to the&#xD;
      patients' medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2022</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of death (all cause)</measure>
    <time_frame>2 years of follow-up</time_frame>
    <description>Number of death within 2 years of discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of rehospitalizations for acute heart failure (HF)</measure>
    <time_frame>2 years of follow-up</time_frame>
    <description>Number of heart failure related hospitalization within 2 years of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of death ( all cause) or readmission for heart failure</measure>
    <time_frame>2 years of follow-up</time_frame>
    <description>Number of Death or heart failure related hospitalization within 2 years of discharge</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <biospec_descr>
    <textblock>
      Blood Samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with heart failure accorrding to Inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years at the time of admission to the hospital&#xD;
&#xD;
          -  With symptoms of new-onset or worsening heart failure&#xD;
&#xD;
          -  Received or is eligible to receive a principal hospital discharge diagnosis of HF&#xD;
&#xD;
          -  With signs and syndromes as follows: dyspnea at rest or with minimal exertion&#xD;
             (dyspnea, orthopnea, or edema)；Rales, peripheral edema, ascites, or pulmonary vascular&#xD;
             congestion on chest radiography.&#xD;
&#xD;
          -  Patients who received packed red blood cells, whole blood, or platelets less than 10&#xD;
             days before the blood sample was taken;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have objective evidence of cardiac dysfunction documented either by plasma&#xD;
             concentrations of BNP and/or N-terminal pro-brain natriuretic peptide (NT-proBNP) &lt;35&#xD;
             pg/mL or &lt;125 pg/ml, respectively&#xD;
&#xD;
          -  Current known inability to follow instructions or comply with follow-up procedures.&#xD;
&#xD;
          -  Eligible patients without informed consent form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jie Du, Dr</last_name>
    <role>Study Director</role>
    <affiliation>The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuan Wang, Dr</last_name>
    <phone>13910161443</phone>
    <email>wangyuan980510@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bingbing Ke, Dr</last_name>
    <phone>15510286857</phone>
    <email>1017120710@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan WANG, PhD</last_name>
      <phone>86-010-64456169</phone>
      <email>wangyuan980510@163.com</email>
    </contact>
    <investigator>
      <last_name>Jie DU, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>April 21, 2019</last_update_submitted>
  <last_update_submitted_qc>April 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Cardiovascular 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/NCT03784833
org study id: BIOMS-HF
nct id: NCT03784833
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The registry study aims to discover the prognostic value of bio-markers in heart failure
The purpose of this study is to investigate the prognostic value of biomarkers in Heart
      Failure.Patients with confirmed diagnosis of heart failure are enrolled.The primary outcome
      is all-cause mortality based on the death certificates. The secondary outcome is readmission
      for heart failure and all-cause mortality/readmission for heart failure according to the
      patients' medical records.
observational model: Cohort
time perspective: Retrospective
measure: Number of death (all cause)
time frame: 2 years of follow-up
description: Number of death within 2 years of discharge
measure: Number of rehospitalizations for acute heart failure (HF)
time frame: 2 years of follow-up
description: Number of heart failure related hospitalization within 2 years of discharge
measure: Number of death ( all cause) or readmission for heart failure
time frame: 2 years of follow-up
description: Number of Death or heart failure related hospitalization within 2 years of discharge
Blood Samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Jie Du, Dr
role: Study Director
affiliation: The Key Laboratory of Remodeling-Related Cardiovascular Disease, Ministry of Education, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart,Lung and Blood Vessel Diseases
last name: Yuan Wang, Dr
phone: 13910161443
email: wangyuan980510@163.com
last name: Bingbing Ke, Dr
phone: 15510286857
email: 1017120710@qq.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Cardiovascular Diseases