3-dimensional Sensor Technology to Quantify Leg-edema
Recruitment status was: Recruiting
The purpose of the study is two-fold:
- to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
- to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.
|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|
- 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
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700023
|Graz, Austria, 8036|
|Principal Investigator:||Friedrich M Fruhwald, MD||Medical University of Graz|