LOVE-HF-2: Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second Pilot

Sponsor

Heartfelt Technologies (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04787393

Collaborator

Blackpool Teaching Hospitals NHS Foundation Trust (Other)

Enrollment

Location

15.8

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Heartfelt device Device: Connected weighing scales

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

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure Second (LOVE-HF-2)

Actual Study Start Date :

Jun 7, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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).	Device: Heartfelt device 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. Device: Connected weighing scales 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.

Arm

Intervention/Treatment

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).

Device: Heartfelt device

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.

Device: Connected weighing scales

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.

Outcome Measures

Primary Outcome Measures

Foot volume measured by the Heartfelt device in the home. [1-6 months]
Foot volume measured by the Heartfelt device in the hospital. [1-6 months]

Secondary Outcome Measures

Patient weight measured in hospital. [1-6months]
Oedema/Edema scores [1-6months]
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)
Left ventricular ejection fraction [1-6months]
Left atrial volume [1-6months]
Diastolic function (E/A, E/E') [1-6months]
Inferior vena cava diameter [1-6months]
TAPSE and TR jet velocity [1-6months]
visually estimated mitral and tricuspid regurgitation [1-6months]
Ankle circumference [1-6months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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.

Exclusion Criteria:

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
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.