Status:
RECRUITING
Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
Lead Sponsor:
Heartfelt Technologies
Collaborating Sponsors:
Manchester University NHS Foundation Trust
University of Glasgow
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 lo...
Detailed Description
Heart failure often causes fluid build-up in the legs and lungs, leading to symptoms like swelling and breathlessness. Spotting these signs early is important to help prevent worsening health and hosp...
Eligibility 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
Key Trial Info
Start Date :
December 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07067658
Start Date
December 18 2025
End Date
July 31 2027
Last Update
December 31 2025
Active Locations (1)
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1
Croydon Health Services NHS Trust
Croydon, Greater London, United Kingdom, CR7 7YE