Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07067658

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

Led by Heartfelt Technologies · Updated on 2025-12-31

300

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

H

Heartfelt Technologies

Lead Sponsor

M

Manchester University NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults >18 years
  • Diagnosis of heart failure (any cause or left ventricular ejection fraction classification), any timeframe
  • Currently prescribed 640 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 suitable for installation of the Heartfelt device
Not Eligible

You will not qualify if you...

  • Amputation of both feet
  • Bed-bound for more than 20 hours per 24-hour period
  • Daily use of bandages on lower limbs
  • Regular wheelchair user inside the home
  • No fixed home address
  • Participation in another interventional trial that may affect study endpoints
  • Life expectancy less than 6 months as judged by investigator
  • Unable to give informed consent due to cognitive impairment
  • Language barriers preventing understanding of trial procedures (unless translation available)
  • Unable to install the device (even with help) for at least 6 months of data capture
  • Severe aortic stenosis or awaiting heart procedure or surgery
  • End stage renal disease (eGFR <20)
  • Pregnancy or lack of contraceptive measures if of child-bearing potential

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Croydon Health Services NHS Trust

Croydon, Greater London, United Kingdom, CR7 7YE

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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