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3-dimensional Sensor Technology to Quantify Leg-edema

NCT ID: NCT01700023

Last Updated: 2012-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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ADHF

Keywords

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acute heart failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with leg-edema

patients with decompensated heart failure presenting with leg-edema

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AIT Austrian Institute of Technology GmbH

OTHER

Sponsor Role collaborator

Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Friedrich M Fruhwald, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University

Graz, , Austria

Site Status RECRUITING

Countries

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Austria

Facility Contacts

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Friedrich M Fruhwald, MD

Role: primary

Other Identifiers

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24-536 ex 11/12

Identifier Type: -

Identifier Source: org_study_id