<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/NCT01726985</url>
  </required_header>
  <id_info>
    <org_study_id>121368</org_study_id>
    <nct_id>NCT01726985</nct_id>
  </id_info>
  <brief_title>Model for Heart Failure ExAcerbation Reduction Trial</brief_title>
  <acronym>HEART</acronym>
  <official_title>Model for Heart Failure ExAcerbation Reduction Trial - &quot;Model HEART&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cleveland Clinic Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heart failure is the leading cause of hospitalizations and readmissions in the United States&#xD;
      and is a tremendous economic strain on our healthcare system. There is currently, based on&#xD;
      national averages, a 30% readmission rate and 10% mortality rate within 3 months of being&#xD;
      hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers&#xD;
      such as BNP to guide inpatient heart failure management. Our own CCF retrospective study&#xD;
      showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L,&#xD;
      and discharging patients with serum sodium above 135 reduces readmission rates significantly.&#xD;
      The purpose of this study is to prospectively use the above mentioned goals in the treatment&#xD;
      of heart failure in order to reduce heart failure readmission and mortality rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All HF patients admitted to CCF will receive a short consent form. The study will enroll&#xD;
      patients for one year. Physicians will initiate / titrate medications and obtain consults as&#xD;
      usual but are highly encourage to keep patients in the hospital until at least 2 of the 3&#xD;
      (above mentioned) criteria are met. Physicians will receive a copy of consent forms,&#xD;
      educational bulletins, and discharge forms (as described in the Physician Education document&#xD;
      which is attached to this application). Log-rank test will be used to compare groups.&#xD;
      Chi-Square will be used to compare prospective patients with retrospective controls (obtained&#xD;
      in 2010).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Hospital Readmission for CHF</measure>
    <time_frame>up to 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>CHF Mortality</measure>
    <time_frame>90 days, 180 days, 1 yr</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">230</enrollment>
  <condition>Acute on Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Patients hospitalized with CHF</arm_group_label>
    <description>Patients hospitalized with CHF Parameter Based Clinical Disposition</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parameter Based Clinical Disposition</intervention_name>
    <description>Parameter Based Clinical Disposition'&#xD;
Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the following 3 criteria are met:&#xD;
NT-ProBNP reduction of &gt; 23% from peak value during admission&#xD;
Fluid Reduction of &gt; 1.3L (orders for I/O q8h required)&#xD;
Serum Sodium of &gt; 135 mmol/L the day of planned discharge</description>
    <arm_group_label>Patients hospitalized with CHF</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients aged 18 and over hospitalized at Cleveland Clinic Florida with diagnosis of&#xD;
        CHF.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have either Acute on Chronic Heart Failure or Chronic Heart Failure regardless of&#xD;
             presenting/primary complaint&#xD;
&#xD;
        To fulfill CHF Dx, MUST have 2+ of the following:&#xD;
&#xD;
          -  Clinical: Dyspnea, orthopnea, PND, edema, S3, rales, improve w diuretics&#xD;
&#xD;
          -  Radiographic: Pulm venous congestion, pleural effs, cardiomegaly&#xD;
&#xD;
          -  Lab: NT pro BNP &gt; 1000&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Marlow Hernandez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</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>
  <patient_data>
    <sharing_ipd>No</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/NCT01726985
org study id: 121368
nct id: NCT01726985
lead sponsor: 
has dmc: No
Heart failure is the leading cause of hospitalizations and readmissions in the United States
      and is a tremendous economic strain on our healthcare system. There is currently, based on
      national averages, a 30% readmission rate and 10% mortality rate within 3 months of being
      hospitalized for heart failure. Retrospective studies have shown benefit to using biomarkers
      such as BNP to guide inpatient heart failure management. Our own CCF retrospective study
      showed that decreasing NT-ProBNP by 23%, making patients fluid negative by more than 1.3L,
      and discharging patients with serum sodium above 135 reduces readmission rates significantly.
      The purpose of this study is to prospectively use the above mentioned goals in the treatment
      of heart failure in order to reduce heart failure readmission and mortality rates.
All HF patients admitted to CCF will receive a short consent form. The study will enroll
      patients for one year. Physicians will initiate / titrate medications and obtain consults as
      usual but are highly encourage to keep patients in the hospital until at least 2 of the 3
      (above mentioned) criteria are met. Physicians will receive a copy of consent forms,
      educational bulletins, and discharge forms (as described in the Physician Education document
      which is attached to this application). Log-rank test will be used to compare groups.
      Chi-Square will be used to compare prospective patients with retrospective controls (obtained
      in 2010).
observational model: Cohort
time perspective: Prospective
measure: Hospital Readmission for CHF
time frame: up to 1 year
measure: CHF Mortality
time frame: 90 days, 180 days, 1 yr
arm group label: Patients hospitalized with CHF
description: Patients hospitalized with CHF Parameter Based Clinical Disposition
intervention type: Other
intervention name: Parameter Based Clinical Disposition
description: Parameter Based Clinical Disposition'
Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the following 3 criteria are met:
NT-ProBNP reduction of > 23% from peak value during admission
Fluid Reduction of > 1.3L (orders for I/O q8h required)
Serum Sodium of > 135 mmol/L the day of planned discharge
arm group label: Patients hospitalized with CHF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marlow Hernandez
role: Principal Investigator
affiliation: Cleveland Clinic Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No