This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

3-dimensional Sensor Technology to Quantify Leg-edema

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Medical University of Graz.
Recruitment status was:  Recruiting
AIT Austrian Institute of Technology GmbH
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: September 30, 2012
Last updated: October 3, 2012
Last verified: October 2012

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.


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:

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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

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)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01700023

Medical University Recruiting
Graz, Austria, 8036
Contact: Friedrich M Fruhwald, MD    +43316385 ext 12544   
Sponsors and Collaborators
Medical University of Graz
AIT Austrian Institute of Technology GmbH
Principal Investigator: Friedrich M Fruhwald, MD Medical University of Graz
  More Information

Responsible Party: Medical University of Graz 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

Keywords provided by Medical University of Graz:
acute heart failure processed this record on September 21, 2017