<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/NCT02998788</url>
  </required_header>
  <id_info>
    <org_study_id>RJ-81600198</org_study_id>
    <nct_id>NCT02998788</nct_id>
  </id_info>
  <brief_title>Risk Evaluation and Management in Heart Failure</brief_title>
  <acronym>REM-HF</acronym>
  <official_title>Risk Evaluation and Management in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an prospective study conducted in a Chinese heart failure population. The study&#xD;
      investigates the effects of cardiovascular disease risk factors such as lifestyle&#xD;
      behaviors,biomarkers and intermediate diseases on heart failure prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart failure is the main cause of cardiovascular death. The primary goal of this study is to&#xD;
      estimate the association of lifestyle behavior (e.g., alcohol, tea and coffee consumption,&#xD;
      sedentary behavior, smoking habit, sleep disorder and physical activity), intermediate&#xD;
      conditions (e.g., hypertension, diabetes and dyslipidemia), genetic risk factors and&#xD;
      circulating biomarkers with heart failure prognosis. Another goal is to improve the health&#xD;
      status and reduce cardiovascular events and death for heart failure patients via patient&#xD;
      education, disease monitoring and medication titration. This study planned to consecutively&#xD;
      enroll 1,000 heart failure patients fulfilling the inclusion criteria. Each participants will&#xD;
      be followed up for at least 5 years. The study endpoints, all-cause mortality and&#xD;
      cardiovascular events, will be identified by directly contacting participants during the&#xD;
      follow-up surveys, checking pertinent medical records and discharge lists from the hospitals,&#xD;
      or checking death certificates from local vital statistics offices. The Cox proportional&#xD;
      hazard model will be used to estimate the risk factors for health outcomes in heart failure&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 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</measure>
    <time_frame>10 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>A composite of cardiovascular events</measure>
    <time_frame>10 years</time_frame>
    <description>A composite of myocardial infarction, revascularization, stroke, rehospitalization due to heart failure and cardiovascular death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>myocardial infarction</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>revascularization</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rehospitalization due to heart failure</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiovascular death</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Heart Failure</condition>
  <condition>Risk Factor, Cardiovascular</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fasting (8-12 hours) venous blood samples were drawn and transfused into vacuum tubes&#xD;
      containing EDTA during the study visits. These samples were stored and further analyzed in&#xD;
      the Central Laboratory of Ruijin Hospital.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients with primary discharge diagnosis of heart failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 and above&#xD;
&#xD;
          -  inpatient with one of the following clinical situations:&#xD;
&#xD;
               -  congestive heart failure (pulmonary edema,pulmonary congestion or peripheral&#xD;
                  edema)&#xD;
&#xD;
               -  cardiogenic shock&#xD;
&#xD;
               -  Insufficient high output cardiac&#xD;
&#xD;
          -  with impaired cardiac function diagnosed by echocardiography&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  expressed refusal to participate in the baseline investigation or follow-up visits&#xD;
             Severe co-morbidity associated with a reduction in life expectancy of less than 12&#xD;
             months&#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>Wei Jin, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhijun Wu, MD</last_name>
    <phone>008613818908053</phone>
    <email>totito19822005@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhijun Wu, MD</last_name>
      <phone>008613818908053</phone>
      <email>totito19822005@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Wei Jin</investigator_full_name>
    <investigator_title>Professor,Department of Cardiology</investigator_title>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>risk factor</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>lifestyle behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT02998788
org study id: RJ-81600198
nct id: NCT02998788
lead sponsor: 
has dmc: Yes
This is an prospective study conducted in a Chinese heart failure population. The study
      investigates the effects of cardiovascular disease risk factors such as lifestyle
      behaviors,biomarkers and intermediate diseases on heart failure prognosis.
Heart failure is the main cause of cardiovascular death. The primary goal of this study is to
      estimate the association of lifestyle behavior (e.g., alcohol, tea and coffee consumption,
      sedentary behavior, smoking habit, sleep disorder and physical activity), intermediate
      conditions (e.g., hypertension, diabetes and dyslipidemia), genetic risk factors and
      circulating biomarkers with heart failure prognosis. Another goal is to improve the health
      status and reduce cardiovascular events and death for heart failure patients via patient
      education, disease monitoring and medication titration. This study planned to consecutively
      enroll 1,000 heart failure patients fulfilling the inclusion criteria. Each participants will
      be followed up for at least 5 years. The study endpoints, all-cause mortality and
      cardiovascular events, will be identified by directly contacting participants during the
      follow-up surveys, checking pertinent medical records and discharge lists from the hospitals,
      or checking death certificates from local vital statistics offices. The Cox proportional
      hazard model will be used to estimate the risk factors for health outcomes in heart failure
      patients.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 10 years
measure: A composite of cardiovascular events
time frame: 10 years
description: A composite of myocardial infarction, revascularization, stroke, rehospitalization due to heart failure and cardiovascular death
measure: myocardial infarction
time frame: 10 years
measure: revascularization
time frame: 10 years
measure: stroke
time frame: 10 years
measure: rehospitalization due to heart failure
time frame: 10 years
measure: cardiovascular death
time frame: 10 years
Fasting (8-12 hours) venous blood samples were drawn and transfused into vacuum tubes
      containing EDTA during the study visits. These samples were stored and further analyzed in
      the Central Laboratory of Ruijin Hospital.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wei Jin, Professor
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Zhijun Wu, MD
phone: 008613818908053
email: totito19822005@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Wei Jin
investigator title: Professor,Department of Cardiology
mesh term: Heart Failure
sharing ipd: Undecided