Heart Failure, DiastolicNCT02993601
Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
An observational study of Heart Failure, Diastolic and Edema Brain, run by Heartfelt Technologies at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Diastolic, Edema Brain, Decompensated Heartfailure
- What is being tested?
- Heartfelt-1, Weighing scales and Medical grading of oedema
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2017to 13 Jun 2017
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults able to give consent to take part in the study
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
The Heartfelt-1 device is a CE (Conformité Européenne = European Conformity) mark medical device used to measure biometric parameters of the foot and lower leg. The study aims at assessing the usefulness in patients suffering from heart failure, who have peripheral oedema. Models used for the measurements of foot and lower legs have not yet been validated for this group of patients, who are likely to have feet with abnormal surface contours and appearance secondary to oedema. Peripheral oedema can be a leading indicator of heart failure de-compensation which can lead to hospitalisation of patients, and therefore the device could be a useful clinical tool to monitor patients in their home. The Heartfelt-1 device has the ability to recognise the patient's feet (amongst an average size household setting), and trigger automatically the measurements when the feet are naked (for example as the patient goes in and out of bed). This makes the device an obvious choice for patients with compliance issues with current methods of monitoring (e.g. daily use of weighing scales) and treatment (e.g. diuretics) if it could be validated in this patient group.
The study has two general aims:
The first is to collect a time-series of data on inpatients with peripheral oedema caused by heart failure, as they receive intravenous or oral diuretic treatment to remove excess fluid and achieve optimal body weight and fluid balance. This data will be used both to determine the attainable resolution of foot biometric measurements on a patient as their fluid status changes, and also to further develop the algorithms used in the device and make them usable on a wide range of feet/lower legs which have been deformed by oedema. The data required for this study are images taken using the Heartfelt-1 device, as well as validation measurements such as the figure of eight using a medical grade tape measure, callipers, or the water displacement method using a volumetric gauge, at multiple time-points whilst the peripheral oedema reduces.
The second, on a second group of stable ambulatory (Heart Failure) HF patients with variable levels of oedema, is to evaluate the performance of the Heartfelt-1 device in determining foot biometric parameters one a wide range of patients at a single point in time. Patients with stable chronic heart failure will have their foot/lower legs measured by the Heartfelt-1 device, as well as standard medical measurement (figure of eight using a medical grade tape measure, callipers) and gold standard measurement (water displacement method using a gauge), as well as the patient's weight and a clinical grading of oedema. These will be compared and an estimate of the accuracy of the Heartfelt-1 device over this wider patient group can be extrapolated.
- Being tested
- Heartfelt-1, Weighing scales, Medical grading of oedema, Baseline assessements, Water displacement method
- Keywords
- Heart Failure, Edema, Oedema, Decompensated Heartfailure
- Medical subject headings
- Heart Failure, Diastolic, Brain Edema, Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartfelt-1Device
Also called HF-1
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.
Weighing scalesDevice
The patient will be asked to stand on standard medical weighing scales, to measure their weight.
Medical grading of oedemaOther
A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
Baseline assessementsOther
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.
Water displacement methodDevice
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.
Callipers measurementsDevice
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.
Measuring tapeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 20 outpatients with peripheral oedema | 20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. Receives: Device: Heartfelt-1; Device: Weighing scales; Other: Medical grading of oedema; Other: Baseline assessements; Device: Water displacement method; Device: Callipers measurements; Device: Measuring tape | |
| 20 cardiology controls | 20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. Receives: Device: Heartfelt-1; Device: Weighing scales; Other: Medical grading of oedema; Other: Baseline assessements; Device: Water displacement method; Device: Callipers measurements; Device: Measuring tape | |
| 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. Receives: Device: Heartfelt-1; Device: Weighing scales; Other: Medical grading of oedema; Other: Baseline assessements; Device: Water displacement method; Device: Callipers measurements; Device: Measuring tape | |
| 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). Receives: Device: Heartfelt-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume as measured by the Heartfelt-1 device
Measured: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Secondary outcomes (5)
Weight
Patient weight on the day
Measured: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Distance measurements
Distance measurements on the foot / lower leg of the patient
Measured: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Circumference and "figure of eight"
Lower leg / foot circumference and "figure of eight" measurement
Measured: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Volume of the lower leg/foot
As measured using the water displacement method.
Measured: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Medical grading of oedema
Medical grading of peripheral oedema on a scale 1-5
Measured: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start15 Jan 2017
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, DiastolicStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartfelt Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alexander Lyon, BCh PhD FRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993601
- Sponsor's protocol ID
- RBH01
- Status last verified
- Oct 2021
- First submitted
- 5 Dec 2016
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: We are not planning to share individual participant data with other researchers.
Publications
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.
PubMed 33880069
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02993601
- Acronym / sponsor ID
- RBH01
- Keywords
- Heart Failure, Edema, Oedema, Decompensated Heartfailure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Heartfelt TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 15 Dec 2016 (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 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.
Detailed description
The Heartfelt-1 device is a CE (Conformité Européenne = European Conformity) mark medical device used to measure biometric parameters of the foot and lower leg. The study aims at assessing the usefulness in patients suffering from heart failure, who have peripheral oedema. Models used for the measurements of foot and lower legs have not yet been validated for this group of patients, who are likely to have feet with abnormal surface contours and appearance secondary to oedema. Peripheral oedema can be a leading indicator of heart failure de-compensation which can lead to hospitalisation of patients, and therefore the device could be a useful clinical tool to monitor patients in their home. The Heartfelt-1 device has the ability to recognise the patient's feet (amongst an average size household setting), and trigger automatically the measurements when the feet are naked (for example as the patient goes in and out of bed). This makes the device an obvious choice for patients with compliance issues with current methods of monitoring (e.g. daily use of weighing scales) and treatment (e.g. diuretics) if it could be validated in this patient group.
The study has two general aims:
The first is to collect a time-series of data on inpatients with peripheral oedema caused by heart failure, as they receive intravenous or oral diuretic treatment to remove excess fluid and achieve optimal body weight and fluid balance. This data will be used both to determine the attainable resolution of foot biometric measurements on a patient as their fluid status changes, and also to further develop the algorithms used in the device and make them usable on a wide range of feet/lower legs which have been deformed by oedema. The data required for this study are images taken using the Heartfelt-1 device, as well as validation measurements such as the figure of eight using a medical grade tape measure, callipers, or the water displacement method using a volumetric gauge, at multiple time-points whilst the peripheral oedema reduces.
The second, on a second group of stable ambulatory (Heart Failure) HF patients with variable levels of oedema, is to evaluate the performance of the Heartfelt-1 device in determining foot biometric parameters one a wide range of patients at a single point in time. Patients with stable chronic heart failure will have their foot/lower legs measured by the Heartfelt-1 device, as well as standard medical measurement (figure of eight using a medical grade tape measure, callipers) and gold standard measurement (water displacement method using a gauge), as well as the patient's weight and a clinical grading of oedema. These will be compared and an estimate of the accuracy of the Heartfelt-1 device over this wider patient group can be extrapolated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 outpatients with peripheral oedema | – | Device: Heartfelt-1, Device: Weighing scales, Other: Medical grading of oedema, Other: Baseline assessements, Device: Water displacement method, Device: Callipers measurements, Device: Measuring tape20 outpatients with clinically detectable peripheral oedema for 1 set of measurements. |
| 20 cardiology controls | – | Device: Heartfelt-1, Device: Weighing scales, Other: Medical grading of oedema, Other: Baseline assessements, Device: Water displacement method, Device: Callipers measurements, Device: Measuring tape20 outpatients with heart failure without clinically detectable peripheral oedema (control group) for 1 set of measurements. |
| 10 in-patients peripheral oedema | – | Device: Heartfelt-1, Device: Weighing scales, Other: Medical grading of oedema, Other: Baseline assessements, Device: Water displacement method, Device: Callipers measurements, Device: Measuring tape10 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 | – | Device: Heartfelt-1less 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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults able to give consent to take part in the study
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heartfelt-1Also: HF-1The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured. | Device | 10 in-patients peripheral oedema, 20 cardiology controls, 20 outpatients with peripheral oedema, 30 control without cardiac conditions |
| Weighing scalesThe patient will be asked to stand on standard medical weighing scales, to measure their weight. | Device | 10 in-patients peripheral oedema, 20 cardiology controls, 20 outpatients with peripheral oedema |
| Medical grading of oedemaA member of the research team will assess the severity of the peripheral oedema on a scale of 1-5. | Other | 10 in-patients peripheral oedema, 20 cardiology controls, 20 outpatients with peripheral oedema |
| Baseline assessementsAt 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. | Other | 10 in-patients peripheral oedema, 20 cardiology controls, 20 outpatients with peripheral oedema |
| Water displacement methodThis 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. | Device | 10 in-patients peripheral oedema, 20 cardiology controls, 20 outpatients with peripheral oedema |
| Callipers measurementsThis 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. | Device | 10 in-patients peripheral oedema, 20 cardiology controls, 20 outpatients with peripheral oedema |
| Measuring tapeThe 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. | Device | 10 in-patients peripheral oedema, 20 cardiology controls, 20 outpatients with peripheral oedema |
Primary outcome
Volume as measured by the Heartfelt-1 device
Time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
5 secondary outcomes
Weight
Time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Distance measurements
Time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Circumference and "figure of eight"
Time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Volume of the lower leg/foot
Time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Medical grading of oedema
Time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Results publication: PubMed 33880069Chausiaux 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.
- Individual participant dataSharing planned: No. We are not planning to share individual participant data with other researchers.
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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.
Alexander Lyon, BCh PhD FRCP principal investigator
Royal Brompton & Harefield NHS Foundation Trust
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 Heart Failure, Diastolic and Edema Brain, run by Heartfelt Technologies at 1 site in United Kingdom.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 13 Oct 2021. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume as measured by the Heartfelt-1 device (time frame: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02993601, which also lists 1 linked publication.
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 13 Oct 2021.