ADHFNCT01700023
3-dimensional Sensor Technology to Quantify Leg-edema
An observational study of ADHF, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHF
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2012to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized for decompensated heart failure with leg-edema
Who may be able to join
- hospitalization for worsening heart failure
- age greater than 18 years
- ability to stand without help from others
- informed consent
Who cannot join
- leg-edema of non-cardiac origin (venous, lymphatic)
- dialysis shunt
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University
Graz, 8036
Friedrich M Fruhwald, MD, +43316385 ext. 12544, friedrich.fruhwald@medunigraz.at
About this study
Official title: Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure
The purpose of the study is two-fold:
- to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
- to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.
Read the 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.
- Conditions
- ADHF
- Keywords
- acute heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with leg-edema | patients with decompensated heart failure presenting with leg-edema |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- AIT Austrian Institute of Technology GmbH
- Responsible party
- Sponsor
- Investigators
- Friedrich M Fruhwald, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700023
- Sponsor's protocol ID
- 24-536 ex 11/12
- Status last verified
- Oct 2012
- First submitted
- 30 Sep 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-study HI-SENS: Innovative Sensor Technology to Quantify Cardiac Control Mechanisms in Heart Failure
- ClinicalTrials.gov ID
- NCT01700023
- Acronym / sponsor ID
- 24-536 ex 11/12
- Conditions
- ADHF
- Keywords
- acute heart failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- AIT Austrian Institute of Technology GmbH
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is two-fold:
- to test 3-dimensional reconstruction of leg-edema in patients hospitalized for acute heart failure with leg-edema.
- to measure changes in QRS-morphology in a simulation of conventional blood-pressure measurement in patients hospitalized for acute heart failure.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with leg-edema | – | –patients with decompensated heart failure presenting with leg-edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized for decompensated heart failure with leg-edema
Key inclusion criteria (4 listed)
- hospitalization for worsening heart failure
- age greater than 18 years
- ability to stand without help from others
- informed consent
Key exclusion criteria (2 listed)
- leg-edema of non-cardiac origin (venous, lymphatic)
- dialysis shunt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedrich M Fruhwald, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHF, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of 3-dimensional measurements (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.