Heart FailureFOOTNCT04072744
Foot Oedema Observed Over Time Study
An observational study of Heart Failure and Edema Leg, run by Heartfelt Technologies at 5 sites in United Kingdom.
Trial summary
Heart Failure is the final common pathway of most forms of cardiovascular disease. In the United Kingdom (UK), it affects around 900 000 people, causes or complicates around 5% of adult emergency hospital admissions and consumes up to 2% of total National Health Service (NHS) expenditure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Edema Leg
- What is being tested?
- Heartfelt measurements and Connected weighing scales
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 11 Dec 2019to 30 Dec 2022
- 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
- Adult, Older adult
Study population: Locally resident patients who are under the care of the cardiology / heart failure team with a high risk for heart failure related hospital admission, are potentially eligible.
Who may be able to join
- Patients age 18 years or older.
- Patient able, agrees and signs the Informed Consent Form.
- Patient with any heart failure diagnosis.
- Patient under the care of a cardiologist with heart failure nurse care.
- Patient with one prolonged inpatient stay
- Patient with significant peripheral oedema at admission
- Patient with significant weight loss following admission (at least 5kg weight loss).
- Patient has been discharged on at least furosemide 80mg or Bumetanide 2mg/d
Who cannot join
- Patient has bandages everyday
- Patient has an amputation of the foot
- Patient lacks capacity to consent
- Patient is of no fixed abode
- Patient has plans for intervention (CRT, Valves)
- Patient taking part in another study
- Patient must not been pregnant, and is taking relevant birth control*
- Note that criteria (g) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (participants are expected to be over 55 years old).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE3 9QP
Bedfordshire Hospitals NHS Foundation Trust
Luton, Bedfordshire, LU4 0DZ
Northumbria Healthcare NHS Foundation Trust
North Shields, Northumbria, NE29 8NH
North Tees and Hartlepool Hospitals NHS Foundation Trust
Stockton-on-Tees, County Durham, TS19 8PE
Torbay and South Devon NHS Foundation Trust
Torquay, Devon, TQ27AA
About this study
Official title: Foot Oedema Observed Over Time in Heart Failure Patients
Heart Failure is the final common pathway of most forms of cardiovascular disease. In the United Kingdom (UK), it affects around 900 000 people, causes or complicates around 5% of adult emergency hospital admissions and consumes up to 2% of total National Health Service (NHS) expenditure. An important part of discharge planning includes measures such as early follow up in order to prevent readmissions. The hallmark of heart failure is fluid retention and between 2009 and 2016, 43% to 50% of hospital admissions were associated with peripheral oedema. Therefore, early recognition of this and treatment of the congestion may prevent hospital admissions. In clinical trials, management strategies have included patient education, telemedicine and remote monitoring. The main non-invasive method for detecting fluid retention has been the use of weight as a surrogate marker.
The Heartfelt device is an invention that uses a system of cameras in a compact device in order to generate 3 dimensional images of the feet and lower legs. The volumes can then be calculated and thus, changes in amount of peripheral oedema can be estimated. In a laboratory study performed by the Heart Failure team at the Royal Brompton Hospital, there was good correlation between measurements made by Heartfelt and a water displacement method. The resolution was as good as 20mls.
Read more
By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Images are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. Personal identifiable data (participant name, address, age…) is stored on an encrypted hard drive, along with linkage information (device serial numbers) to associate the participant identifiable data with the data captured in the home. Therefore, data collection is not only secure but entirely passive, which is a major advantage compared with previous non-invasive methods and it is applicable to a very wide range of compliant and non-compliant patients.
Our hypothesis is that the Heartfelt device can directly detect the increase in peripheral oedema associated with heart failure decompensation and that, on average, the number of days with missing data collected by the Heartfelt device will be lower than that of the weighing scales.
Read the detailed description
This is a phase 2 observational study during which Subjects with chronic heart failure will be monitored in their home using the Heartfelt device.
The participant inclusion criteria will be those patients who are at high risk of hospital admission with a primary diagnosis of chronic heart failure or pulmonary oedema due to Heart failure (HF), during either of which peripheral oedema was also noted.
When heart failure decompensates, the amount of peripheral oedema that is clinically significant is unknown. The main objective of this study is to characterise the volume changes indicative of an increased risk for subsequent hospitalisation.
Subjects will also be provided with electronic, internet connected weighing scales that can transmit data and asked to weigh themselves daily. Temporal changes in weight and volume will be compared.
The study period will be 6 months and is the interval between installation of the Heartfelt device and the study end. participants will be made aware that the data collected by the device will not be reviewed during the study and therefore that they should continue with reporting symptoms and issues as usual to their care team.
In the event that it takes more than 2 years to recruit 20 participants, the study team will stop recruiting after 2 years so the study will be considered complete when all participants recruited up to that point have been monitored for 6 months.
participants under the care of the Trust have the following post diagnosis care:
- Patient Education and Training in self management
- Daily weighing
- Diuretic management
- Discharged under cardiologist
- Home visit by heart failure nurse (HFN) at 7-10d
- Urgent contact info for HF team
- Subsequent HF care by
- HFN either at home or at community hospital
- Consultant cardiologist
The Heartfelt Device will be provided in addition to these and not replace any of these activities.
During the study period, data will be collected from the Heartfelt device (passively) and a set of connected weighing scales (as and when the participant steps on the scales). Any decisions made by the subject to seek medical help will not be influenced by the research team or the Heartfelt device readings as those would be concealed to the participant and research team until appropriate review during the study. The participant will however be able to see the readings on the weighing scales as they step on it.
Retrospective analysis of the participant's notes which may indicate change in medications or care will be mapped to the foot volumes and weights collected.
For those participants for whom decompensation occurs during the study period, the participants are seen by their healthcare professionals, and a clinical examination will be made as usual in a timely manner to determine the amount of peripheral oedema. This will be logged allowing retrospective comparison with the volume measurements.
The temporal relationship between volume changes and decompensation will be investigated. The additional effect of clinical status data will be assessed.
As the participation in a scientific study is known to modify behaviour, the information collected by scales and general reporting frequency of symptoms will be compared to the 6 months before the study and the 6 months after. The time to recruit participants should correct for any seasonal effect on this data.
- Conditions
- Heart Failure, Edema Leg
- Being tested
- Heartfelt measurements, Connected weighing scales
- Keywords
- Peripheral oedema, Peripheral edema, Heart failure, Decompensation, Weight, Hospital admissions
- Medical subject headings
- Heart Failure, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartfelt measurementsDevice
The measurements taken using the Heartfelt device do not require contact with the participant. For the measurements to take place, the participant will simply walk in the field of view of the device. As the device(s) will have been installed at a location allowing the best view of where the participant goes in an out of bed, the participant is not expected to change anything to their routine.
The device can also take measurements in the dark, so if the participant walks in front of the device in the dark, this information will also be captured.
The Heartfelt device is a CE (European Conformity) marked product. Neither the participant, or the medical team will be able to see the data collected by the Heartfelt device during the study. They will be blinded to the data until each participant has completed the study. At that point they can choose to review the data from participant individually or wait until all the data from all participants is available.
Connected weighing scalesDevice
The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional. The weighing scales display weight so that the participants can record the weight in their own heart failure records.
The participant will be able to see the weight readings on the weighing scales during the study.
The scales will communicate with the Personal Computer (PC) contained in the Heartfelt device and the data will be sent to the Heartfelt server through an encrypted link.
| Study group | Role | What they receive |
|---|---|---|
| Participants | General Study Participants Receives: Device: Heartfelt measurements; Device: Connected weighing scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in foot volume prior to Heart failure related hospital admission
The primary outcome is the change in foot volume between baseline and the last observed foot volume measurement prior to hospital admission for a given patient. This will aim to demonstrate the ability of the heartfelt system to provide advance warning of impending hospitalisation.
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Frequency of data collection by the Heartfelt Device
the frequency with which the heartfelt system collects patient data in comparison to standard care (weighing scales).
Measured: Through study completion, an average of 6 months
Correlation between foot volume and significant medical intervention
The correlation between the dates of significant medical interventions (change of diuretics, hospital admission...) and difference in foot volumes to baseline measured by the Heartfelt device.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start11 Dec 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartfelt Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Torbay and South Devon NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Phil Keeling, MD, Principal investigator, Torbay and South Devon NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072744
- Sponsor's protocol ID
- TSD01
- Acronym
- FOOT
- Status last verified
- Feb 2023
- First submitted
- 23 Aug 2019
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Oedema Observed Over Time in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04072744
- Acronym / sponsor ID
- FOOT / TSD01
- Conditions
- Heart Failure, Edema Leg
- Keywords
- Peripheral oedema, Peripheral edema, Heart failure, Decompensation, Weight, Hospital admissions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Heartfelt TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Torbay and South Devon NHS Foundation Trust
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- 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.
Heart Failure is the final common pathway of most forms of cardiovascular disease. In the United Kingdom (UK), it affects around 900 000 people, causes or complicates around 5% of adult emergency hospital admissions and consumes up to 2% of total National Health Service (NHS) expenditure. An important part of discharge planning includes measures such as early follow up in order to prevent readmissions. The hallmark of heart failure is fluid retention and between 2009 and 2016, 43% to 50% of hospital admissions were associated with peripheral oedema. Therefore, early recognition of this and treatment of the congestion may prevent hospital admissions. In clinical trials, management strategies have included patient education, telemedicine and remote monitoring. The main non-invasive method for detecting fluid retention has been the use of weight as a surrogate marker.
The Heartfelt device is an invention that uses a system of cameras in a compact device in order to generate 3 dimensional images of the feet and lower legs. The volumes can then be calculated and thus, changes in amount of peripheral oedema can be estimated. In a laboratory study performed by the Heart Failure team at the Royal Brompton Hospital, there was good correlation between measurements made by Heartfelt and a water displacement method. The resolution was as good as 20mls.
By positioning the Heartfelt device in the bedroom, automatic measurements can be made whenever the subject gets in and out of bed. Images are only taken of the specified subject. Data is censored so that the part of the body which is 50cm above the floor is not stored. Encrypted, anonymised data is transmitted over the internet to the company's secure servers. Personal identifiable data (participant name, address, age…) is stored on an encrypted hard drive, along with linkage information (device serial numbers) to associate the participant identifiable data with the data captured in the home. Therefore, data collection is not only secure but entirely passive, which is a major advantage compared with previous non-invasive methods and it is applicable to a very wide range of compliant and non-compliant patients.
Our hypothesis is that the Heartfelt device can directly detect the increase in peripheral oedema associated with heart failure decompensation and that, on average, the number of days with missing data collected by the Heartfelt device will be lower than that of the weighing scales.
Detailed description
This is a phase 2 observational study during which Subjects with chronic heart failure will be monitored in their home using the Heartfelt device.
The participant inclusion criteria will be those patients who are at high risk of hospital admission with a primary diagnosis of chronic heart failure or pulmonary oedema due to Heart failure (HF), during either of which peripheral oedema was also noted.
When heart failure decompensates, the amount of peripheral oedema that is clinically significant is unknown. The main objective of this study is to characterise the volume changes indicative of an increased risk for subsequent hospitalisation.
Subjects will also be provided with electronic, internet connected weighing scales that can transmit data and asked to weigh themselves daily. Temporal changes in weight and volume will be compared.
The study period will be 6 months and is the interval between installation of the Heartfelt device and the study end. participants will be made aware that the data collected by the device will not be reviewed during the study and therefore that they should continue with reporting symptoms and issues as usual to their care team.
In the event that it takes more than 2 years to recruit 20 participants, the study team will stop recruiting after 2 years so the study will be considered complete when all participants recruited up to that point have been monitored for 6 months.
participants under the care of the Trust have the following post diagnosis care:
- Patient Education and Training in self management
- Daily weighing
- Diuretic management
- Discharged under cardiologist
- Home visit by heart failure nurse (HFN) at 7-10d
- Urgent contact info for HF team
- Subsequent HF care by
- HFN either at home or at community hospital
- Consultant cardiologist
The Heartfelt Device will be provided in addition to these and not replace any of these activities.
During the study period, data will be collected from the Heartfelt device (passively) and a set of connected weighing scales (as and when the participant steps on the scales). Any decisions made by the subject to seek medical help will not be influenced by the research team or the Heartfelt device readings as those would be concealed to the participant and research team until appropriate review during the study. The participant will however be able to see the readings on the weighing scales as they step on it.
Retrospective analysis of the participant's notes which may indicate change in medications or care will be mapped to the foot volumes and weights collected.
For those participants for whom decompensation occurs during the study period, the participants are seen by their healthcare professionals, and a clinical examination will be made as usual in a timely manner to determine the amount of peripheral oedema. This will be logged allowing retrospective comparison with the volume measurements.
The temporal relationship between volume changes and decompensation will be investigated. The additional effect of clinical status data will be assessed.
As the participation in a scientific study is known to modify behaviour, the information collected by scales and general reporting frequency of symptoms will be compared to the 6 months before the study and the 6 months after. The time to recruit participants should correct for any seasonal effect on this data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Device: Heartfelt measurements, Device: Connected weighing scalesGeneral Study Participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Locally resident patients who are under the care of the cardiology / heart failure team with a high risk for heart failure related hospital admission, are potentially eligible.
Key inclusion criteria (8 listed)
- Patients age 18 years or older.
- Patient able, agrees and signs the Informed Consent Form.
- Patient with any heart failure diagnosis.
- Patient under the care of a cardiologist with heart failure nurse care.
- Patient with one prolonged inpatient stay
Key exclusion criteria (8 listed)
- Patient has bandages everyday
- Patient has an amputation of the foot
- Patient lacks capacity to consent
- Patient is of no fixed abode
- Patient has plans for intervention (CRT, Valves)
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 measurementsThe measurements taken using the Heartfelt device do not require contact with the participant. For the measurements to take place, the participant will simply walk in the field of view of the device. As the device(s) will have been installed at a location allowing the best view of where the participant goes in an out of bed, the participant is not expected to change anything to their routine. The device can also take measurements in the dark, so if the participant walks in front of the device in the dark, this information will also be captured. The Heartfelt device is a CE (European Conformity) marked product. Neither the participant, or the medical team will be able to see the data collected by the Heartfelt device during the study. They will be blinded to the data until each participant has completed the study. At that point they can choose to review the data from participant individually or wait until all the data from all participants is available. | Device | Participants |
| Connected weighing scalesThe participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional. The weighing scales display weight so that the participants can record the weight in their own heart failure records. The participant will be able to see the weight readings on the weighing scales during the study. The scales will communicate with the Personal Computer (PC) contained in the Heartfelt device and the data will be sent to the Heartfelt server through an encrypted link. | Device | Participants |
Primary outcome
Change in foot volume prior to Heart failure related hospital admission
Time frame: Through study completion, an average of 6 months
The primary outcome is the change in foot volume between baseline and the last observed foot volume measurement prior to hospital admission for a given patient. This will aim to demonstrate the ability of the heartfelt system to provide advance warning of impending hospitalisation.
2 secondary outcomes
Frequency of data collection by the Heartfelt Device
Time frame: Through study completion, an average of 6 months
Correlation between foot volume and significant medical intervention
Time frame: Through study completion, an average of 6 months
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 2 Feb 2023.
- Individual participant dataSharing planned: No. No identifiable data will be shared 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.
Phil Keeling, MD principal investigator
Torbay and South Devon NHS Foundation Trust
5 sites 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 and Edema Leg, run by Heartfelt Technologies at 5 sites 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 8 inclusion and 8 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 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Change in foot volume prior to Heart failure related hospital admission (time frame: Through study completion, an average of 6 months). 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 2 Feb 2023.