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