3-dimensional Sensor Technology to Quantify Leg-edema

ADHF Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01700023
• Other study ID #: 24-536 ex 11/12
• Status: Unknown status
• Phase: N/A
• First received: September 30, 2012
• Last updated: October 3, 2012
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: October 2012
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ADHF

Locations

Country	Name	City	State
Austria	Medical University	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	AIT Austrian Institute of Technology GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of 3-dimensional measurements	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