Heart Failure Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Croydon Health Services NHS Trust
RECRUITING
Croydon
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 300
Treatments
Experimental: Enhanced Standard Care + Heartfelt Device
Heartfelt device's camera-based system passively measures foot and leg swelling each day as participants walk past it. Patients in this experimental control arm will not receive health alerts from the Heartfelt device, though data will still be passively collected.~Patients will also be provided with the British Heart Foundation patient booklet to improve their understanding and self-monitoring of the disease.
Active_comparator: Enhanced Standard Care (Control)
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians.~Patients will also be provided with the British Heart Foundation patient booklet to improve their understanding and self-monitoring of the disease.
Related Therapeutic Areas
Sponsors
Collaborators: Manchester University NHS Foundation Trust, University of Glasgow
Leads: Heartfelt Technologies

This content was sourced from clinicaltrials.gov