Feasibility study of a new peripheral oedema monitor for heart failure
Research type
Research Study
Full title
Evaluation of the safety and feasibility of a new peripheral oedema monitor for home and clinical use for heart failure patients, using the Heartfelt-1 device
IRAS ID
220157
Contact name
Alexander Lyon
Contact email
Sponsor organisation
Heartfelt Technologies Lld
Clinicaltrials.gov Identifier
2016-004968-19, EudraCT number
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
The Heartfelt-1 device is a CE mark medical device used to measure biometric parameters of the foot and lower leg. The study aims at assessing the usefulness in patients suffering from heart failure, who have peripheral oedema. Models used for the measurements of foot and lower legs have not yet been validated for this group of patients, who are likely to have feet with abnormal surface contours and appearance secondary to oedema. Peripheral oedema can be a leading indicator of heart failure de-compensation which can lead to hospitalisation of patients, and therefore the device could be a useful clinical tool to monitor patients in their home. The Heartfelt-1 device has the ability to recognise the patient's feet (amongst an average size household setting), and trigger automatically the measurements when the feet are naked (for example as the patient goes in and out of bed). This makes the device an obvious choice for patients with compliance issues with current methods of monitoring (e.g. daily use of weighing scales) and treatment (e.g. diuretics) if it could be validated in this patient group.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
16/WM/0522
Date of REC Opinion
20 Dec 2016
REC opinion
Further Information Favourable Opinion