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3-dimensional Sensor Technology to Quantify Leg-edema

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ClinicalTrials.gov Identifier: NCT01700023
Recruitment Status : Unknown
Verified October 2012 by Medical University of Graz.
Recruitment status was:  Recruiting
First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Collaborator:
AIT Austrian Institute of Technology GmbH
Information provided by (Responsible Party):
Medical University of Graz

Study Description
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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
ADHF

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
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Study Type : Observational
Estimated 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 : September 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Heart Failure

Groups and Cohorts
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Group/Cohort
patients with leg-edema
patients with decompensated heart failure presenting with leg-edema


Outcome Measures
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Primary Outcome Measures :
  1. accuracy of 3-dimensional measurements [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients hospitalized for decompensated heart failure with leg-edema
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700023


Locations
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Austria
Medical University Recruiting
Graz, Austria, 8036
Contact: Friedrich M Fruhwald, MD    +43316385 ext 12544    friedrich.fruhwald@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
AIT Austrian Institute of Technology GmbH
Investigators
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Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
More Information
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01700023    
Other Study ID Numbers: 24-536 ex 11/12
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012
Keywords provided by Medical University of Graz:
acute heart failure