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3-dimensional Sensor Technology to Quantify Leg-edema

Sponsor
Medical University of Graz (Other)
Overall Status
Unknown status
CT.gov ID
NCT01700023
Collaborator
AIT Austrian Institute of Technology GmbH (Other)
15
Enrollment
1
Location
5.9
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure
    Study Start Date :
    Sep 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2012
    Anticipated Study Completion Date :
    Mar 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    patients with leg-edema

    patients with decompensated heart failure presenting with leg-edema

    Outcome Measures

    Primary Outcome Measures

    1. accuracy of 3-dimensional measurements [10 days]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • hospitalization for worsening heart failure

    • age greater than 18 years

    • ability to stand without help from others

    • informed consent

    Exclusion Criteria:

    • leg-edema of non-cardiac origin (venous, lymphatic)

    • dialysis shunt

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Graz Austria 8036

    Sponsors and Collaborators

    • Medical University of Graz
    • AIT Austrian Institute of Technology GmbH

    Investigators

    • Principal Investigator: Friedrich M Fruhwald, MD, Medical University of Graz

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical University of Graz
    ClinicalTrials.gov Identifier:
    NCT01700023
    Other Study ID Numbers:
    • 24-536 ex 11/12
    First Posted:
    Oct 4, 2012
    Last Update Posted:
    Oct 4, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Medical University of Graz
    acute heart failure

    Study Results

    No Results Posted as of Oct 4, 2012