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3-dimensional Sensor Technology to Quantify Leg-edema

This study is currently recruiting participants.
Verified October 2012 by Medical University of Graz
Sponsor:
Collaborator:
AIT Austrian Institute of Technology
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01700023
First received: September 30, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

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
ADHF

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Edema Heart Failure
U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • accuracy of 3-dimensional measurements [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with leg-edema
patients with decompensated heart failure presenting with leg-edema

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700023

Locations
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
Investigators
Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01700023     History of Changes
Other Study ID Numbers: 24-536 ex 11/12
Study First Received: September 30, 2012
Last Updated: October 3, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
acute heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013