Foot Oedema Observed Over Time Study

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. 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.

Conditions

• Heart Failure
• Edema Leg

Interventions

DEVICE

Heartfelt measurements

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.

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. 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.

Sponsors & Collaborators

• Torbay and South Devon NHS Foundation Trust

  collaborator OTHER

• Heartfelt Technologies

  lead INDUSTRY

Principal Investigators

• Phil Keeling, MD · Torbay and South Devon NHS Foundation Trust

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-11

Primary Completion

2022-12-30

Completion

2022-12-30

Countries

• United Kingdom

Study Locations