Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
Recruiting now · Not applicable
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT07067658
- Run by
- Heartfelt Technologies
- People needed
- 300
- Starts
- 2025-12-18
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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 it is running
- Walsall Manor Hospital — Walsall, United Kingdom (enrolling)
- Croydon Health Services NHS Trust — Croydon, Greater London, United Kingdom (enrolling)
- Hertfordshire Community NHS Trust — Welwyn Garden City, Hertfordshire, United Kingdom (enrolling)
- Holderness Health — Patrington, Hull, United Kingdom (enrolling)
- Kent Community Health NHS Foundation Trust — Ashford, Kent, United Kingdom (enrolling)
- Lincolnshire Community Health Services NHS Trust — Lincoln, Lincolnshire, United Kingdom (enrolling)
- North Tees & Hartlepool NHS Foundation Trust — Hardwick, Stockton-on-Tees, United Kingdom (enrolling)
- Chilwell Valley and Meadows Practice — Nottingham, United Kingdom (enrolling)
- Royal Glamorgan Hospital — Pont-y-clun, United Kingdom (enrolling)
- Buckinghamshire Healthcare NHS Trust — Aylesbury, Buckinghamshire, United Kingdom (enrolling)
- Princess of Wales Hospital — Bridgend, United Kingdom (enrolling)
- Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde) — Glasgow, United Kingdom (enrolling)
- St George's Hospital — London, United Kingdom (enrolling)
- Manchester University NHS Foundation Trust — Manchester, United Kingdom (enrolling)
- Milton Keynes University Hospital NHS Foundation Trust — Milton Keynes, United Kingdom (enrolling)
- Ulster Hospital — Belfast, United Kingdom
- Hull University Teaching Hospitals NHS Trust — Hull, United Kingdom
- Livewell Southwest — Plymouth, United Kingdom
Full record on ClinicalTrials.gov
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