Monitoring leg swelling in heart failure to improve function and reduce hospital visits
Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
This test will try using the Heartfelt device—a hands-free foot imaging sensor that spots early fluid buildup—to see if it helps people with heart failure have better quality of life and fewer heart-failure-related events when added to usual NHS care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heartfelt Technologies Industry-sponsored |
| Locations | 1 site (Croydon, Greater London) |
| Trial ID | NCT07067658 on ClinicalTrials.gov |
What this trial studies
Three hundred people with heart failure at around 15 NHS hospitals and GP practices across the UK will be randomly assigned to usual NHS care or usual care plus the Heartfelt device. The device sits in the home and takes daily 3D images of the feet and lower legs to detect changes in volume without extra effort from the user, and only people in the device arm generate clinical alerts. The partly blinded design means participants may see technical messages but only device-triggered alerts reach clinical teams; outcomes include quality of life, healthcare use, device data completeness, and clinical responses to alerts. The study will also examine device usability, implementation, and cost-effectiveness, with patient partners helping shape the trial.
Who should consider this trial
Good fit: Adults in the UK with diagnosed heart failure who are taking at least 40 mg/day (or equivalent) of loop diuretic, have had a heart-failure admission and moderate or severe leg oedema in the past year, and live in a home suitable for device installation.
Not a fit: Patients unlikely to benefit include those who are bed-bound, have both feet amputated, use a wheelchair at home, require daily lower-limb bandaging, have very limited life expectancy, or cannot consent or engage with the device.
Why it matters
Potential benefit: If successful, the device could detect fluid buildup earlier so clinicians can act sooner, potentially reducing hospital admissions and preserving daily function.
How similar studies have performed: Remote heart-failure monitoring using weight checks or implantable pressure sensors has produced mixed but sometimes positive results, while passive 3D foot-volume imaging is a relatively new approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Croydon, Greater London
- Croydon Health Services NHS Trust — Croydon, Greater London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.