<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/NCT01675544</url>
  </required_header>
  <id_info>
    <org_study_id>12-16350</org_study_id>
    <nct_id>NCT01675544</nct_id>
  </id_info>
  <brief_title>PRospective Evaluation of Electrocardiographic Voltage Changes and Six Minute Walk Test for Predicting Readmissions in Heart Failure (PREEMT-HF Study)</brief_title>
  <acronym>PREEMT-HF</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Creighton University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Creighton University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between&#xD;
      admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with&#xD;
      acute heart failure can identify patients at risk for recurrent admissions for heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective Determine the ability of EKG voltage changes and pre discharge 6-minute&#xD;
      walk test (6-MWT) to predict repeat heart failure hospitalization (HFH) in patients admitted&#xD;
      with acute decompensated heart failure (ADHF).&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. Determine the ability of EKG voltage changes and pre discharge 6-MWT) to predict a&#xD;
           composite of 1 year mortality and HFH in patients admitted with ADHF.&#xD;
&#xD;
        2. Determine the ability of proportionate pulse pressure, orthostatic blood pressure&#xD;
           changes and pre discharge inferior vena cava (IVC) diameter by portable ultrasound to&#xD;
           predict HFH and mortality&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 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>Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>All cause mortality at 1 year</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Heart Failure Admission</arm_group_label>
    <description>Patients admitted for acute decompensated heart failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocardiogram</intervention_name>
    <description>EKG voltage changes between admission and discharge</description>
    <arm_group_label>Heart Failure Admission</arm_group_label>
    <other_name>EKG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Six minute walk test</intervention_name>
    <arm_group_label>Heart Failure Admission</arm_group_label>
    <other_name>6-MWT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted with acute decompensated heart failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt; 18 years of age, admitted with a diagnosis of ADHF and fulfilling the&#xD;
             following criteria:&#xD;
&#xD;
               1. Evidence of systemic congestion (manifested by any 2 of the following criteria:&#xD;
                  jugular venous distension, edema, pulmonary rales, Left ventricular S3, or&#xD;
                  radiographic evidence of pulmonary venous congestion)&#xD;
&#xD;
               2. Elevated Brain natriuretic peptide&#xD;
&#xD;
               3. Need for at least 1 dose of intravenous loop diuretic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock, Acute coronary syndromes (patients with mild elevation in troponin&#xD;
             related to heart failure will not be excluded), patients who are admitted for another&#xD;
             principal problem and develop ADHF in the hospital, pregnant females, end stage renal&#xD;
             disease on hemodialysis, expected survival &lt; 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Venkata M Alla, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Creighton University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Creighton University Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>September 25, 2014</results_first_submitted>
  <results_first_submitted_qc>September 25, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 29, 2014</results_first_posted>
  <last_update_submitted>November 27, 2015</last_update_submitted>
  <last_update_submitted_qc>November 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2015</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>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Heart Failure Admission</title>
          <description>Patients admitted for acute decompensated heart failure&#xD;
Electrocardiogram: EKG voltage changes between admission and discharge&#xD;
Six minute walk test</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Heart Failure Admission</title>
          <description>Patients admitted for acute decompensated heart failure&#xD;
Electrocardiogram: EKG voltage changes between admission and discharge&#xD;
Six minute walk test</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Heart Failure Admission</title>
            <description>Patients admitted for acute decompensated heart failure&#xD;
Electrocardiogram: EKG voltage changes between admission and discharge&#xD;
Six minute walk test</description>
          </group>
        </group_list>
        <measure>
          <title>Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mortality</title>
        <description>All cause mortality at 1 year</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Heart Failure Admission</title>
            <description>Patients admitted for acute decompensated heart failure&#xD;
Electrocardiogram: EKG voltage changes between admission and discharge&#xD;
Six minute walk test</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>All cause mortality at 1 year</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Heart Failure Admission</title>
          <description>Patients admitted for acute decompensated heart failure&#xD;
Electrocardiogram: EKG voltage changes between admission and discharge&#xD;
Six minute walk test</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Venkata M. Alla</name_or_title>
      <organization>Creighton University School of Medicine</organization>
      <phone>(402) 280-4292</phone>
      <email>venkataalla@creighton.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01675544
org study id: 12-16350
nct id: NCT01675544
lead sponsor: 
has dmc: No
Purpose of the study: To identify whether Electrocardiographic QRS voltage changes (between
      admission and pre-discharge) and pre discharge 6- minute walk test in patients admitted with
      acute heart failure can identify patients at risk for recurrent admissions for heart failure.
Primary Objective Determine the ability of EKG voltage changes and pre discharge 6-minute
      walk test (6-MWT) to predict repeat heart failure hospitalization (HFH) in patients admitted
      with acute decompensated heart failure (ADHF).

      Secondary Objectives

        1. Determine the ability of EKG voltage changes and pre discharge 6-MWT) to predict a
           composite of 1 year mortality and HFH in patients admitted with ADHF.

        2. Determine the ability of proportionate pulse pressure, orthostatic blood pressure
           changes and pre discharge inferior vena cava (IVC) diameter by portable ultrasound to
           predict HFH and mortality
observational model: Cohort
time perspective: Prospective
measure: Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)
time frame: 1 year
measure: Mortality
time frame: 1 year
description: All cause mortality at 1 year
arm group label: Heart Failure Admission
description: Patients admitted for acute decompensated heart failure
intervention type: Procedure
intervention name: Electrocardiogram
description: EKG voltage changes between admission and discharge
arm group label: Heart Failure Admission
other name: EKG
intervention type: Procedure
intervention name: Six minute walk test
arm group label: Heart Failure Admission
other name: 6-MWT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Venkata M Alla, MBBS
role: Principal Investigator
affiliation: Creighton University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 