LOVE-HF2
Research type
Research Study
Full title
Lancashire Objective Volume Evaluation of leg oedema in Heart Failure (LOVE-HF2)
IRAS ID
313639
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
The LOVE-HF2 is an observational study with heart failure patients being monitored at home, in order to test the feasibility of oedema detection across the full range of oedema levels in the home, and validity of alerts generated by the Heartfelt device.
Blackpool Victoria Hospital provides acute heart failure service both for in-patients and out-patients, including capacity to administer parenteral furosemide in the hospital cardiac day case unit, community, or home settings.
Patients who have had recent decompensated heart failure (within six months of the last dose of IV Diuretic or the last dose of augmented oral diuretic treatment) will be included. We aim to recruit 30 participants for the study.Patients will receive internet connected weighing scales and the Heartfelt device for their home. These may be installed by the company if the patient so wishes. Each patient will participate for a period between 1 to 6 months. The study duration will be based on the time of recruitment, with patients recruited early in the study able to be monitored for a longer period of time.
During this period, the Heartfelt device will raise different alerts:
“Health alerts”, which the research fellow will respond to in a timely fashion by examining the patient and recording results of the full oedema assessment (see Appendix F), as well as measure the patient’s ankle circumference (See Appendix G for details), their weight and take a controlled measurement using a Hospital Heartfelt device in a pre-specified set up. A short questionnaire (see Appendix I for details) will also be administered at the end of the measures.
“High alerts”, “Low alerts” and “Random alerts” which will be raised to try to optimise the range of volumes measured for each patient, by trying to predict when the patient is as close as possible to their dry weight and possibly with increased oedema levels. Again, the research fellow will assess the patient and perform the same activities as for “Health alerts”.In addition, an administrator from the Heartfelt team will also call the patient to ask the short questionnaire (see Appendix I for details) in order to ensure that there is no bias which has been introduced by having the doctor caring for them asking patients how they are feeling.
Although it would be better to have the answers to the questionnaires at the same time as the measurements are being taken, the PPI group expressed concern that some patients may feel that they should provide an answer that is expected of them to the doctor, rather than how they really feel. So having a second administration of the question will allow this possible bias to be reviewed.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0084
Date of REC Opinion
5 May 2022
REC opinion
Further Information Favourable Opinion