LOVE-HF
Research type
Research Study
Full title
Lancashire Objective Volume Evaluation of leg oedema in Heart Failure (LOVE-HF) Pilot Randomised Controlled Cross-over Trial programme (LOVE-HF and LOVE-HF-2)
IRAS ID
289790
Contact name
Kenneth Wong
Contact email
Sponsor organisation
Heartfelt Technologies Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
We are assessing how good changes in foot volume detected by a new medical device can be at detecting heart failure decompensation, and reducing the risk of hospital admission.
Swollen ankles are caused by a build-up of fluid (oedema); if it can be identified, by asking patients to report symptoms or weight gain, it has been shown to help reduce the risk of hospitalisation. However, many patients get hospitalised because they have not been able to notice or report such changes. We are looking to establish if this type of device could help those patients in future.
The device we are investigating is installed in the patients’ home and scans their feet from a distance, as they walk around or get in and out of bed, to measure the volume of their ankle. This data can be sent to the patient's doctor who will determine if the patient requires a change to their medication.
It is important that, before recommending a new device to patients we compare it to the current standard of care, which is regular weighing and symptom reporting (the target audience for this device is unable to do this regularly).
The study will be run in 2 phases. In the first, participants will be randomly allocated to one of two arms: in one the device will not report any data to their doctor (standard care only), and in the other arm the device will report alerts for the doctor (Heartfelt + standard care). In LOVE-HF-2, participants will randomly be allocated to one of two arms, either Heartfelt + reporting symptoms, or weighing + reporting symptoms (standard care only).In both parts of the study after 30 days, the participants will be crossed over the other arm.
REC name
London - City & East Research Ethics Committee
REC reference
21/PR/0057
Date of REC Opinion
16 Feb 2021
REC opinion
Favourable Opinion