NCT01700023

Brief Summary

The purpose of the study is two-fold:

  1. 1.to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
  2. 2.to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

September 30, 2012

Last Update Submit

October 3, 2012

Conditions

ADHF

Keywords

acute heart failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients with leg-edema

patients with decompensated heart failure presenting with leg-edema

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients hospitalized for decompensated heart failure with leg-edema

You may qualify if:

  • hospitalization for worsening heart failure
  • age greater than 18 years
  • ability to stand without help from others
  • informed consent

You may not qualify if:

  • leg-edema of non-cardiac origin (venous, lymphatic)
  • dialysis shunt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Graz, 8036, Austria

RECRUITING

Study Officials

  • Friedrich M Fruhwald, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2012

First Posted

October 4, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations

AU(1)