Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
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,
| Condition(s) | Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: Participants are eligible if they meet all General Criteria and at least one of Pathways A, B, or C. 1\. General Criteria (all participants must meet) * Aged ≥18 years, AND * Diagnosis of heart failure (any aetiology or LVEF classification), AND * Documented or patient-reported moderate to severe leg oedema, AND * Lives in the UK with a home environment suitable for installation of the Heartfelt device Pathway A: High risk patient with daily diuretics * Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic, eg. bumetanide or torsemide) for at least one month, AND * Any cardiorespiratory admission\*\* in the last 12 months (Includes outpatient IV diuretics, subcutaneous loop diuretics, or escalation to combination therapy with a loop diuretic and a t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Heartfelt Technologies |
| Locations | Aylesbury, Buckinghamshire, United Kingdom; Croydon, Greater London, United Kingdom; Welwyn Garden City, Hertfordshire, United Kingdom; Patrington, Hull, United Kingdom; Ashford, Kent, United Kingdom; Lincoln, Lincolnshire, United Kingdom (+12 more sites) |
| Start date | 2025-12-18 |
| NCT ID | NCT07067658 |
| Official listing | https://clinicaltrials.gov/study/NCT07067658 |