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.
Heart failure often causes fluid build-up in the legs and lungs, leading to symptoms like swelling and breathlessness. Spotting these signs early is important to help prevent worsening health and hospital admissions. While patients are encouraged to monitor their weight and symptoms, this can be hard to keep up with. The study will involve 300 participants from at least 15 NHS hospitals and GP practices across the UK. People will be randomly placed into one of two groups: one will receive standard NHS care (including regular weight checks and symptom monitoring), and the other will receive the same care plus the Heartfelt device. The trial is partly blinded: participants may see technical messages (e.g. if the device goes offline), but only the group using the device will trigger clinical alerts. The Heartfelt device takes daily images of the feet to track changes in size, without the need for any extra effort from the user. If important changes are spotted, alerts are sent to the clinical team so they can act quickly. The study will look at quality of life, how often the device sends useful data, healthcare use, and how teams respond to alerts. It will also explore how easy the device is to use and whether it offers good value for money. Patients will help shape the study to make sure the findings are relevant and useful for future care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
300
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
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.
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Buckinghamshire Healthcare NHS Trust
Aylesbury, Buckinghamshire, United Kingdom
RECRUITINGComposite Clinical Events
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.
Time frame: Over 12-months period.
Health-Related Quality of Life (EQ-5D-5L)
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.
Time frame: Collected at baseline, 3, 6, 9, and 12 months
Days Lost to Hospitalisation or Death
Total number of days lost due to hospitalisation for cardiovascular, respiratory, or renal conditions, or due to all-cause mortality.
Time frame: Over 12-months period.
Daily Data Availability
Proportion of days with successful data capture from the Heartfelt device and weighing scales, based on device-generated records or contemporaneous self-report.
Time frame: Over 12-months period.
Guideline-Recommended Medication Score
Adherence to guideline-recommended heart failure medications will be assessed using a guideline-recommended medication score, calculated at 3, 6, 9, and 12 months and averaged across these time points. The score is based on the number of eligible medication classes prescribed, with 1 point assigned per class (e.g., ACEi/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist \[MRA\]). The score ranges from 0 to 3, with 3 being the optimal medication score. The score is adjusted for patient eligibility: will be calculated only for patients with heart failure with reduced ejection fraction (HFrEF).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Croydon Health Services NHS Trust
Croydon, Greater London, United Kingdom
RECRUITINGHertfordshire Community NHS Trust
Welwyn Garden City, Hertfordshire, United Kingdom
RECRUITINGHolderness Health
Patrington, Hull, United Kingdom
RECRUITINGKent Community Health NHS Foundation Trust
Ashford, Kent, United Kingdom
RECRUITINGLincolnshire Community Health Services NHS Trust
Lincoln, Lincolnshire, United Kingdom
RECRUITINGNorth Tees & Hartlepool NHS Foundation Trust
Hardwick, Stockton-on-Tees, United Kingdom
RECRUITINGUlster Hospital
Belfast, United Kingdom
NOT_YET_RECRUITINGPrincess of Wales Hospital
Bridgend, United Kingdom
RECRUITINGQueen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)
Glasgow, United Kingdom
RECRUITING...and 8 more locations
Time frame: Over 12-months period.
All-Cause Hospitalisations
Number of hospitalisations from any cause, analysed as recurrent events and adjusted for the competing risk of death.
Time frame: Over 12-months period.
Loss of Independence or Mortality
Composite measure of new admission to a long-term care facility or all-cause mortality.
Time frame: During the 12-month trial period.
Death and Cause of Death
Classification of all deaths recorded during the trial as heart failure-related, other cardiovascular, or non-cardiovascular causes, based on clinical records.
Time frame: During 12-months trial period.