Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
Condition(s) studied
Investigational drug(s) / intervention(s)
Installation of Heartfelt Device: Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Enhanced Standard care: Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. They should also report changes in breathlessness, tiredness and other symptoms associated with heart failure decompensation. At the start of the study, they will be reminded (or told) about the importance of self-checks and will be handed a patient booklet (from the British Heart Foundation) to standardise patients' knowledge.
Questionnaires: Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt device alerting system: The Heartfelt device sends alerts on the active comparator arm to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.
Study summary
This study will evaluate the Heartfelt device, a novel, passive monitoring system that detects early signs of fluid build-up in patients (oedema) with heart failure by measuring changes in foot and lower leg volume through capture of 3D images. The trial will assess whether this device, when added to standard NHS care, improves quality of life and reduces heart failure-related events compared to standard care alone.
Eligibility
Primary outcome measure(s)
- Composite Clinical Events — Over 12-months period.
Unplanned hospital attendance (clinic, emergency, or admission) or death due to heart failure, cardiovascular, respiratory, or renal causes. Recurrent events will be included and adjudicated, providing a comprehensive measure of clinical deterioration over 12 months. - Health-Related Quality of Life (EQ-5D-5L) — Collected at baseline, 3, 6, 9, and 12 months
Patient-reported quality of life measured using EQ-5D-5L, collected at baseline and follow-up (3, 6, 9, 12 months), with primary analysis at 12 months. This validated instrument captures overall health status across five domains and includes a visual analogue scale. * Measured using the EQ-5D-5L index * Collected at baseline, 3, 6, 9, and 12 months. * Primary time point: 12 months. EQ-5D-5L responses will be converted to utility scores on a scale from -0.59 to 1, where 1 represents the best health state, using the UK EQ-5D-5L value set. Patients with at least two or more utility scores during follow-up will be included in the analysis.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Buckinghamshire Healthcare NHS Trust | Aylesbury | Buckinghamshire | Recruiting |
| Croydon Health Services NHS Trust | Croydon | Greater London | Recruiting |
| Hertfordshire Community NHS Trust | Welwyn Garden City | Hertfordshire | Recruiting |
| Holderness Health | Patrington | Hull | Recruiting |
| Kent Community Health NHS Foundation Trust | Ashford | Kent | Recruiting |
| Lincolnshire Community Health Services NHS Trust | Lincoln | Lincolnshire | Recruiting |
| North Tees & Hartlepool NHS Foundation Trust | Hardwick | Stockton-on-Tees | Recruiting |
| Ulster Hospital | Belfast | United Kingdom | Not Yet Recruiting |
| Princess of Wales Hospital | Bridgend | United Kingdom | Recruiting |
| Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde) | Glasgow | United Kingdom | Recruiting |
| Hull University Teaching Hospitals NHS Trust | Hull | United Kingdom | Not Yet Recruiting |
| St George's Hospital | London | United Kingdom | Recruiting |
| Manchester University NHS Foundation Trust | Manchester | United Kingdom | Recruiting |
| Milton Keynes University Hospital NHS Foundation Trust | Milton Keynes | United Kingdom | Recruiting |
| Chilwell Valley and Meadows Practice | Nottingham | United Kingdom | Recruiting |
| Livewell Southwest | Plymouth | United Kingdom | Not Yet Recruiting |
| Royal Glamorgan Hospital | Pont-y-clun | United Kingdom | Recruiting |
| Walsall Manor Hospital | Walsall | United Kingdom | Recruiting |
More Heartfelt Technologies trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07067658 on ClinicalTrials.gov ↗ ← All trials in the UK