Heart FailureLOVE-HF-2NCT04787393
Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot
An observational study of Heart Failure, run by Heartfelt Technologies at 1 site in United Kingdom.
Trial summary
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited in the LOVE-HF-2 trial at Blackpool Victoria Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heartfelt device and Connected weighing scales
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2022to 26 Oct 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
- No healthy volunteers
- Adult, Older adult
Study population: Participants in this study will be chosen to be close representatives of the target population for the device: Heart failure patients at high risk of decompensation, with associated peripheral oedema.
Who may be able to join
- Patients with HF who recently (< 6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) who are treated with at least 80 mg furosemide (or equivalent) orally per day Patients with HF older than 18 years Patients who took part in LOVE-HF can also be approached.
- The research team will try to include as many patients as possible in the month following discharge, however we will not exclude consideration of a small proportion of patients within 6 months of decompensation. This has the extra advantage of demonstrating the value of the device beyond 1-2 months of decompensation.
Who cannot join
- Inability to provide informed consent*
- Participant has bandages to lower limbs everyday
- Participant has an amputation of the foot
- Participant is a regular wheelchair user
- Participant is of no fixed abode
- Participant has a potentially reversible cause of decompensated heart failure and is awaiting urgent intervention (revascularisation/ valvular heart disease), which means the patient cannot be discharged for home-based care
Show all 11Show fewer
- Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
- Participant must not be pregnant, and is taking relevant birth control if of child-bearing potential*
- Note that a participant not able to comply with weighing, or questionnaires is NOT an exclusion criteria as the Heartfelt device should provide data for these participants despite their lack of ability to adhere to the usual monitoring protocol, and this is seen as one of the long term benefits that the device can provide.
- This exclusion criteria (a) has been added as participants would need to be able to communicate directly with the Heartfelt team, etc.
- This exclusion criteria (h) has been requested by the insurance provider for clinical trial cover.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cardiology, Lancashire Cardiac Centre, Blackpool Teaching Hospital
Blackpool, Lancashire, FY3 9NR
About this study
Official title: Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second (LOVE-HF-2)
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited in the LOVE-HF-2 trial at Blackpool Victoria Hospital. The main objective of the study is to test if the Heartfelt device is sensitive to change across the full range of the individual patient's oedema. The participants will be given the Heartfelt device to use in their home. This device automatically and passively measures patient's foot and lower leg's volume without the patient having to remember to do anything. The patients will be seen face to face with a cardiologist to evaluate peripheral oedema using standard clincial technics as well as overall congestion level. The investigators aim to recruit 30 participants for the observational pilot study.
The study follows its sister pilot trial, LOVE-HF (NCT04787380).
Read the detailed description
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 clinical trial (NCT02993601) 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.
The LOVE-HF trial (NCT04787380) demonstrated that the number of days with missing data collected by the Heartfelt device was significantly lower than that of the weighing scales, providing a promising tool for home patient monitoring.
Being able to demonstrate that the device can provide a measure of oedema that is clinically relevant over the full range of individual patient's oedema is the main objective of this study as this will further adds to the validation of the device.
- Conditions
- Heart Failure
- Being tested
- Heartfelt device, Connected weighing scales
- Keywords
- Heart Failure, Edema leg, Quality of life, Hospital Admissions, Days alive out of hospital, Heartfelt Device, Artificial Intelligence
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartfelt deviceDevice
The Heartfelt device uses a system of scanner in a compact device to generate depth images of the feet and lower legs with a view to detecting early volume changes. The device can be installed on the wall or as a free standing unit, For the measurements to take place, the participant walks in the field of view of the device, measurments are only taken when the patients has bare feet and no slippers/shoes, so the location of the device in the home is choosen to match this requirement. Participants are not expected to change anything to their routine. The device can also take measurements in the dark.
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 if they wish to do so.
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.
The data from the scales will be reviewed retrospectively, as the comparison in this study is with standard care, not with enhanced provision of care, which would be the case if we were using automatic reporting of weights.
| Study group | Role | What they receive |
|---|---|---|
| LOVE-HF-2 Participants | Participants will have the Heartfelt device as well as a set of weighing scales installed at home.
Alerts will be raised for the patient to be seen at home or in clinic by clinician ( the clinician will be blinded to the type of alert). During this face-to-face encounter, the clinician will perform a detailed oedema assessment (recording pitting depth, time of recovery, height oedema, overall grading), ankle circumference measurement, weight measurements, and echo (Left ventricular ejection fraction, Left atrial volumes, inferior vena cava diameter, Diastolic function (E/A, E/E'), TAPSE and TR jet velocity + visually estimated mitral and tricuspid regurgitation). Receives: Device: Heartfelt device; Device: Connected weighing scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot volume measured by the Heartfelt device in the home.
Measured: 1-6 months
Foot volume measured by the Heartfelt device in the hospital.
Measured: 1-6 months
Secondary outcomes (9)
Patient weight measured in hospital.
Measured: 1-6months
Oedema/Edema scores
The clinical oedema scores is a matrix of oedema eight, depth at each of the prespecified location on the leg and time for recovery at each of the prespecified (Brodovicz et al., Clin Med Res 2009). The time for recovery is presented in seconds for each prespecified location on each leg. The depth is presented in millimeters for each prespecified location on each leg.
The NICOR oedema score (No, Mild, Moderate, Severe) is also recorded. A bespoke scale is also used to record oedema height (0=None, 1=Includes ankle but non higher; 2=Above ankle, up to and including the knee; 3=Above the knee)
Measured: 1-6months
Left ventricular ejection fraction
Measured: 1-6months
Left atrial volume
Measured: 1-6months
Diastolic function (E/A, E/E')
Measured: 1-6months
Inferior vena cava diameter
Measured: 1-6months
TAPSE and TR jet velocity
Measured: 1-6months
visually estimated mitral and tricuspid regurgitation
Measured: 1-6months
Ankle circumference
Measured: 1-6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start7 Jun 2022
- Primary completion26 Oct 2022
- Study completion26 Oct 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartfelt Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Blackpool Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Christopher Cassidy, Principal investigator, Blackpool Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787393
- Sponsor's protocol ID
- BTH01.2
- Acronym
- LOVE-HF-2
- Status last verified
- Oct 2022
- First submitted
- 3 Mar 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second (LOVE-HF-2)
- ClinicalTrials.gov ID
- NCT04787393
- Acronym / sponsor ID
- LOVE-HF-2 / BTH01.2
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Edema leg, Quality of life, Hospital Admissions, Days alive out of hospital, Heartfelt Device, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Heartfelt TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Blackpool Teaching Hospitals NHS Foundation Trust
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 8 Mar 2021 (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.
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited in the LOVE-HF-2 trial at Blackpool Victoria Hospital. The main objective of the study is to test if the Heartfelt device is sensitive to change across the full range of the individual patient's oedema. The participants will be given the Heartfelt device to use in their home. This device automatically and passively measures patient's foot and lower leg's volume without the patient having to remember to do anything. The patients will be seen face to face with a cardiologist to evaluate peripheral oedema using standard clincial technics as well as overall congestion level. The investigators aim to recruit 30 participants for the observational pilot study.
The study follows its sister pilot trial, LOVE-HF (NCT04787380).
Detailed description
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 clinical trial (NCT02993601) 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.
The LOVE-HF trial (NCT04787380) demonstrated that the number of days with missing data collected by the Heartfelt device was significantly lower than that of the weighing scales, providing a promising tool for home patient monitoring.
Being able to demonstrate that the device can provide a measure of oedema that is clinically relevant over the full range of individual patient's oedema is the main objective of this study as this will further adds to the validation of the device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LOVE-HF-2 Participants | – | Device: Heartfelt device, Device: Connected weighing scalesParticipants will have the Heartfelt device as well as a set of weighing scales installed at home. Alerts will be raised for the patient to be seen at home or in clinic by clinician ( the clinician will be blinded to the type of alert). During this face-to-face encounter, the clinician will perform a detailed oedema assessment (recording pitting depth, time of recovery, height oedema, overall grading), ankle circumference measurement, weight measurements, and echo (Left ventricular ejection fraction, Left atrial volumes, inferior vena cava diameter, Diastolic function (E/A, E/E'), TAPSE and TR jet velocity + visually estimated mitral and tricuspid regurgitation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be chosen to be close representatives of the target population for the device: Heart failure patients at high risk of decompensation, with associated peripheral oedema.
Key inclusion criteria (2 listed)
- Patients with HF who recently (< 6 months) received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema (any degree) who are treated with at least 80 mg furosemide (or equivalent) orally per day Patients with HF older than 18 years Patients who took part in LOVE-HF can also be approached.
- The research team will try to include as many patients as possible in the month following discharge, however we will not exclude consideration of a small proportion of patients within 6 months of decompensation. This has the extra advantage of demonstrating the value of the device beyond 1-2 months of decompensation.
Key exclusion criteria (11 listed)
- Inability to provide informed consent*
- Participant has bandages to lower limbs everyday
- Participant has an amputation of the foot
- Participant is a regular wheelchair user
- Participant is of no fixed abode
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 deviceThe Heartfelt device uses a system of scanner in a compact device to generate depth images of the feet and lower legs with a view to detecting early volume changes. The device can be installed on the wall or as a free standing unit, For the measurements to take place, the participant walks in the field of view of the device, measurments are only taken when the patients has bare feet and no slippers/shoes, so the location of the device in the home is choosen to match this requirement. Participants are not expected to change anything to their routine. The device can also take measurements in the dark. | Device | LOVE-HF-2 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 if they wish to do so. 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. The data from the scales will be reviewed retrospectively, as the comparison in this study is with standard care, not with enhanced provision of care, which would be the case if we were using automatic reporting of weights. | Device | LOVE-HF-2 Participants |
Primary outcome
Foot volume measured by the Heartfelt device in the home.
Time frame: 1-6 months
Foot volume measured by the Heartfelt device in the hospital.
Time frame: 1-6 months
9 secondary outcomes
Patient weight measured in hospital.
Time frame: 1-6months
Oedema/Edema scores
Time frame: 1-6months
Left ventricular ejection fraction
Time frame: 1-6months
Left atrial volume
Time frame: 1-6months
Diastolic function (E/A, E/E')
Time frame: 1-6months
Inferior vena cava diameter
Time frame: 1-6months
TAPSE and TR jet velocity
Time frame: 1-6months
visually estimated mitral and tricuspid regurgitation
Time frame: 1-6months
Ankle circumference
Time frame: 1-6months
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 28 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Christopher Cassidy principal investigator
Blackpool Teaching Hospitals 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, 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 2 inclusion and 11 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 28 Oct 2022. 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?
Foot volume measured by the Heartfelt device in the home. (time frame: 1-6 months). The study lists 2 primary outcomes in all. 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 28 Oct 2022.