<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/NCT03288701</url>
  </required_header>
  <id_info>
    <org_study_id>EKNZ 2017-00845</org_study_id>
    <nct_id>NCT03288701</nct_id>
  </id_info>
  <brief_title>Smart SCALEs With Bioimpedance Analysis for Treatment Guidance in Decompensated Heart Failure</brief_title>
  <acronym>SCALE HF</acronym>
  <official_title>SCALE HF - Smart SCALEs With Bioelectrical Impedance Analysis for Treatment Guidance in Decompensated Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this trial the measurement of whole body water will be compared to the standard method of&#xD;
      measuring the body weight as treatment guidance in patients with decompensated heart failure.&#xD;
      The Seca mBCA 515 [medical Body Composition Analyser] will be used to quantify the whole body&#xD;
      water by using bioelectrical impedance analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will include 153 participants hospitalized in the University Hospital in Basel.&#xD;
      Daily measurements of whole body water and body weight will be performed in each person until&#xD;
      diuretic treatment is stopped or the patient is discharged from hospital, respectively.&#xD;
&#xD;
      Primary endpoint is the correlation between reduction of whole body water (in kg) and&#xD;
      reduction of body weight (in kg) in patients with decompensated heart failure receiving&#xD;
      forced diuretic treatment (max. deviation +/- 1kg).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">September 27, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of total body water (TBW) in kg</measure>
    <time_frame>From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.</time_frame>
    <description>total body water (TBW) in kg will be measured daily</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of body weight (BW) in kg</measure>
    <time_frame>From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.</time_frame>
    <description>body weight (BW) in kg will be measured daily</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of fatty tissue (FT) in kg</measure>
    <time_frame>From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.</time_frame>
    <description>To provide a more exact comparison of total body water and body weight, fatty mass will be subtracted from the body weight. Subsequently the absolute difference between the reduction of the total body water (in kg) and the reduction of the body weight (in kg), in which fatty tissue (in kg) was subtracted, will be calculated (e.g. (BW day 1- FT day 1) - (BW day 2 - FT day 2) = reduction of BW without fatty tissue).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Heart Failure; With Decompensation</condition>
  <arm_group>
    <arm_group_label>Body Composition Analysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily measurement of the Body Composition using electrical Bioimpedance Analysis in a scale (seca mBCA 515). Including total body water and weight.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Seca medical Body Composition Analyser 515</intervention_name>
    <description>Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment</description>
    <arm_group_label>Body Composition Analysis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to give informed consent&#xD;
&#xD;
          -  hospitalization because of decompensated heart failure treated with forced diuresis&#xD;
&#xD;
          -  able to stand on the scale without help from others and able to hold handrails with&#xD;
             both hands&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal to share personal data&#xD;
&#xD;
          -  implantable electronic device (e.g. Pacemaker, etc.)&#xD;
&#xD;
          -  condition that does not allow skin contact of soles of feet and scale or hands with&#xD;
             handrail (leg prosthesis, wounds, bandage, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jens Eckstein, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>BS</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>cardial decompensation</keyword>
  <keyword>smart scale</keyword>
  <keyword>bioimpedance analysis</keyword>
  <keyword>whole body water</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>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/NCT03288701
org study id: EKNZ 2017-00845
nct id: NCT03288701
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this trial the measurement of whole body water will be compared to the standard method of
      measuring the body weight as treatment guidance in patients with decompensated heart failure.
      The Seca mBCA 515 [medical Body Composition Analyser] will be used to quantify the whole body
      water by using bioelectrical impedance analysis.
Investigators will include 153 participants hospitalized in the University Hospital in Basel.
      Daily measurements of whole body water and body weight will be performed in each person until
      diuretic treatment is stopped or the patient is discharged from hospital, respectively.

      Primary endpoint is the correlation between reduction of whole body water (in kg) and
      reduction of body weight (in kg) in patients with decompensated heart failure receiving
      forced diuretic treatment (max. deviation +/- 1kg).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Measurement of total body water (TBW) in kg
time frame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
description: total body water (TBW) in kg will be measured daily
measure: Measurement of body weight (BW) in kg
time frame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
description: body weight (BW) in kg will be measured daily
measure: Measurement of fatty tissue (FT) in kg
time frame: From baseline until the date of hospital discharge or stop date of forced diuretic treatment, whichever came first, assessed up to 2 weeks.
description: To provide a more exact comparison of total body water and body weight, fatty mass will be subtracted from the body weight. Subsequently the absolute difference between the reduction of the total body water (in kg) and the reduction of the body weight (in kg), in which fatty tissue (in kg) was subtracted, will be calculated (e.g. (BW day 1- FT day 1) - (BW day 2 - FT day 2) = reduction of BW without fatty tissue).
arm group label: Body Composition Analysis
arm group type: Experimental
description: Daily measurement of the Body Composition using electrical Bioimpedance Analysis in a scale (seca mBCA 515). Including total body water and weight.
intervention type: Device
intervention name: Seca medical Body Composition Analyser 515
description: Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment
arm group label: Body Composition Analysis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jens Eckstein, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No