Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
Evaluation of the Safety and Feasibility of a New Peripheral Oedema Monitor for Home and Clinical Use for Heart Failure Patients, Using the Heartfelt-1 Device
1 other identifier
observational
70
1 country
1
Brief Summary
The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering from heart failure, who have peripheral oedema. The device is non-contact and does not requires patient compliance to work. It gives an output reading of the patient's lower leg volume. During the study, this measurement will be compared to clinical standard and gold standard measurements as well as clinical grading of peripheral oedema.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2017
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
December 5, 2016
CompletedFirst Posted
Study publicly available on registry
December 15, 2016
CompletedStudy Start
First participant enrolled
January 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2017
CompletedOctober 13, 2021
October 1, 2021
5 months
December 5, 2016
October 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Volume as measured by the Heartfelt-1 device
Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Secondary Outcomes (5)
Weight
Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Distance measurements
Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Circumference and "figure of eight"
Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Volume of the lower leg/foot
Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Medical grading of oedema
Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Study Arms (4)
20 outpatients with peripheral oedema
20 outpatients with clinically detectable peripheral oedema for 1 set of measurements.
20 cardiology controls
20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements.
10 in-patients peripheral oedema
10 in patients hospitalised as a result of heart failure and fluid congestion with peripheral oedema, those patients will have several sets of measurements taken over time to measure the reduction of peripheral oedema which is likely to show common features with the formation of peripheral oedema.
30 control without cardiac conditions
less than 30 normal controls (healthy volunteers and patients without heart failure) in the age group 55 and above who agree to have images taken using the Heartfelt-1 device (not the whole set of measurements).
Interventions
The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
The patient will be asked to stand on standard medical weighing scales, to measure their weight.
A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.
This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.
This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.
The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.
Eligibility Criteria
Adults able to give consent to take part in the study
You may qualify if:
- Inpatients with admission for de-compensated heart failure requiring increase or initiation of diuretic therapy for fluid congestion.
- Patients attending cardiology outpatients at the Royal Brompton hospital with a diagnosis of heart failure and fluid retention.
- Cardiology patient without fluid retention (cardiology controls) Non-Cardiology patient without fluid retention (controls)
You may not qualify if:
- Patients unable to provide informed consent.
- Unstable arrhythmias in previous 48 hours
- Systolic BP\<90mmHg or need for inotropic support
- Ulceration on lower limbs (below shin) - excluded from water displacement but could have image recording and calipers
- Inability to transfer from bed to chair
- Patients with broken skin or cellulitis will not have their foot volume measured using the water displacement equipment to reduce the risk of infection for the patient and other participants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Related Publications (1)
Chausiaux O, Williams G, Nieznanski M, Bagdu A, Downer P, Keyser M, Husheer S. Evaluation of the Accuracy of a Video and AI Solution to Measure Lower Leg and Foot Volume. Med Devices (Auckl). 2021 Apr 13;14:105-118. doi: 10.2147/MDER.S297713. eCollection 2021.
PMID: 33880069RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Lyon, BCh PhD FRCP
Royal Brompton and Harefield NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2016
First Posted
December 15, 2016
Study Start
January 15, 2017
Primary Completion
June 13, 2017
Study Completion
June 13, 2017
Last Updated
October 13, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
We are not planning to share individual participant data with other researchers.