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Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
Sponsor: Heartfelt Technologies
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-12-18
Completion Date
2027-07-31
Last Updated
2025-12-31
Healthy Volunteers
No
Conditions
Interventions
Installation of Heartfelt Device
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
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.
Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
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