RECRUITINGINTERVENTIONAL

Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults \>18 years - Diagnosis of heart failure (any aetiology or left ventricular ejection fraction classification), any timeframe - Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic) for at least one month. - Heart failure hospital admission and moderate or severe leg oedema in the previous 12 months. - Lives in the UK, with a home environment suitable for installation of the Heartfelt device. Who Should NOT Join This Trial: - Amputation of both feet - Bed-bound for more than 20h per 24h period - Bandages to lower limbs every day - Regular wheelchair user inside their home - No fixed abode - Participation in another interventional trial that may interfere with endpoints - Life expectancy \<6 months, in the opinion of the investigator - Inability to provide willing to sign a consent form due to cognitive impairment - Language barriers that preclude understanding of trial procedures (unless translation resources are available in relevant language) - Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study. - Patients with severe aortic stenosis or awaiting a heart procedure or surgery - Patient with end stage renal disease (eGFR \<20) - Pregnancy or lack of contraceptive measures if of child-bearing potential Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Adults \>18 years * Diagnosis of heart failure (any aetiology or left ventricular ejection fraction classification), any timeframe * Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic) for at least one month. * Heart failure hospital admission and moderate or severe leg oedema in the previous 12 months. * Lives in the UK, with a home environment suitable for installation of the Heartfelt device. Exclusion Criteria: * Amputation of both feet * Bed-bound for more than 20h per 24h period * Bandages to lower limbs every day * Regular wheelchair user inside their home * No fixed abode * Participation in another interventional trial that may interfere with endpoints * Life expectancy \<6 months, in the opinion of the investigator * Inability to provide informed consent due to cognitive impairment * Language barriers that preclude understanding of trial procedures (unless translation resources are available in relevant language) * Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study. * Patients with severe aortic stenosis or awaiting a heart procedure or surgery * Patient with end stage renal disease (eGFR \<20) * Pregnancy or lack of contraceptive measures if of child-bearing potential

Treatments Being Tested

DEVICE

Installation of Heartfelt Device

Device installed in the patient's home and capturing foot volume data which are processed in the cloud.

OTHER

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.

OTHER

Questionnaires

Patients are presented with one or more optional questionnaires (some validated, some bespoke)

DEVICE

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.

Locations (1)

Croydon Health Services NHS Trust

Croydon, Greater London, United Kingdom