3-dimensional Sensor Technology to Quantify Leg-edema

October 3, 2012 updated by: Medical University of Graz

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

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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients hospitalized for decompensated heart failure with leg-edema

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

AIT Austrian Institute of Technology GmbH

Investigators

  • Principal Investigator: Friedrich M Fruhwald, MD, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

September 30, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 3, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-536 ex 11/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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