Skip to content

3-dimensional Sensor Technology to Quantify Leg-edema

Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01700023
Enrollment
15
Registered
2012-10-04
Start date
2012-09-30
Completion date
2013-03-31
Last updated
2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHF

Keywords

acute heart failure

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.

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.

Interventions

None listed

Sponsors

AIT Austrian Institute of Technology GmbH
CollaboratorOTHER
Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
accuracy of 3-dimensional measurements10 daysthe 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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026