3-dimensional Sensor Technology to Quantify Leg-edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Medical University of Graz.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AIT Austrian Institute of Technology GmbH
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
  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:


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
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 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 GmbH
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

ClinicalTrials.gov processed this record on October 19, 2014