<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/NCT01700023</url>
  </required_header>
  <id_info>
    <org_study_id>24-536 ex 11/12</org_study_id>
    <nct_id>NCT01700023</nct_id>
  </id_info>
  <brief_title>3-dimensional Sensor Technology to Quantify Leg-edema</brief_title>
  <official_title>Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AIT Austrian Institute of Technology GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is two-fold:&#xD;
&#xD;
        1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute&#xD;
           heart failure with leg-edema.&#xD;
&#xD;
        2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure&#xD;
           measurement in patients hospitalized for acute heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Leg-edema are common in patients with worsening heart failure. Apart from using a measuring&#xD;
      tape there is no standardized tool to quantify leg-edema. Consequently, in patents with heart&#xD;
      failure early detection of leg-edema is quite difficult.&#xD;
&#xD;
      From earlier pacemaker-studies it has been shown that an increase of afterload changes&#xD;
      ECG-signals. Currently it is unknown how simple diagnostic procedures such as measuring&#xD;
      blood-pressure affect QRS-morphology in patients with heart failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>accuracy of 3-dimensional measurements</measure>
    <time_frame>10 days</time_frame>
    <description>the 3-D camera will record changes in leg-shape around the ankles that result from reabsorption of fluid. These changes will be compared with changes in leg-circumference using a measuring tape</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15</enrollment>
  <condition>ADHF</condition>
  <arm_group>
    <arm_group_label>patients with leg-edema</arm_group_label>
    <description>patients with decompensated heart failure presenting with leg-edema</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients hospitalized for decompensated heart failure with leg-edema&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalization for worsening heart failure&#xD;
&#xD;
          -  age greater than 18 years&#xD;
&#xD;
          -  ability to stand without help from others&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  leg-edema of non-cardiac origin (venous, lymphatic)&#xD;
&#xD;
          -  dialysis shunt&#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>Friedrich M Fruhwald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Friedrich M Fruhwald, MD</last_name>
      <phone>+43316385</phone>
      <phone_ext>12544</phone_ext>
      <email>friedrich.fruhwald@medunigraz.at</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute heart failure</keyword>
  <pending_results>
    <submitted>October 28, 2013</submitted>
    <returned>December 17, 2013</returned>
    <submitted>June 11, 2014</submitted>
    <returned>July 11, 2014</returned>
    <submitted>October 2, 2015</submitted>
    <returned>November 3, 2015</returned>
  </pending_results>
  <!-- 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/NCT01700023
org study id: 24-536 ex 11/12
nct id: NCT01700023
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is two-fold:

        1. to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute
           heart failure with leg-edema.

        2. to measure changes in QRS-morphology in a simulation of conventional blood-pressure
           measurement in patients hospitalized for acute heart failure.
Leg-edema are common in patients with worsening heart failure. Apart from using a measuring
      tape there is no standardized tool to quantify leg-edema. Consequently, in patents with heart
      failure early detection of leg-edema is quite difficult.

      From earlier pacemaker-studies it has been shown that an increase of afterload changes
      ECG-signals. Currently it is unknown how simple diagnostic procedures such as measuring
      blood-pressure affect QRS-morphology in patients with heart failure.
observational model: Cohort
time perspective: Prospective
measure: accuracy of 3-dimensional measurements
time frame: 10 days
description: the 3-D camera will record changes in leg-shape around the ankles that result from reabsorption of fluid. These changes will be compared with changes in leg-circumference using a measuring tape
arm group label: patients with leg-edema
description: patients with decompensated heart failure presenting with leg-edema
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Friedrich M Fruhwald, MD
role: Principal Investigator
affiliation: Medical University of Graz
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Sponsor
submitted: October 28, 2013
returned: December 17, 2013
submitted: June 11, 2014
returned: July 11, 2014
submitted: October 2, 2015
returned: November 3, 2015