Monitoring leg swelling in heart failure to improve function and reduce hospital visits

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Three hundred people with heart failure at around 15 NHS hospitals and GP practices across the UK will be randomly assigned to usual NHS care or usual care plus the Heartfelt device. The device sits in the home and takes daily 3D images of the feet and lower legs to detect changes in volume without extra effort from the user, and only people in the device arm generate clinical alerts. The partly blinded design means participants may see technical messages but only device-triggered alerts reach clinical teams; outcomes include quality of life, healthcare use, device data completeness, and clinical responses to alerts. The study will also examine device usability, implementation, and cost-effectiveness, with patient partners helping shape the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria: Participants are eligible if they meet all General Criteria and at least one of Pathways A, B, or C.

1\. General Criteria (all participants must meet)

* Aged ≥18 years, AND
* Diagnosis of heart failure (any aetiology or LVEF classification), AND
* Documented or patient-reported moderate to severe leg oedema, AND
* Lives in the UK with a home environment suitable for installation of the Heartfelt device

Pathway A: High risk patient with daily diuretics

* Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic, eg. bumetanide or torsemide) for at least one month, AND
* Any cardiorespiratory admission\*\* in the last 12 months (Includes outpatient IV diuretics, subcutaneous loop diuretics, or escalation to combination therapy with a loop diuretic and a thiazide or thiazide-like diuretic (eg: metolazone, bendroflumethiazide, indapamide etc).

Pathway B: High risk patient without daily diuretics

* Patients prescribed SGLT2 inhibitor (eg; dapagliflozin or empagliflozin) , AND
* Patients prescribed oral furosemide ≥40mg/day but advised to take it only as needed AND either:

  a) at least two admissions\* caused or complicated by worsening heart failure in the previous 12 months, OR b) a measurement of plasma NT-proBNP exceeding 1,000 ng/L (pg/mL) in the previous 12 months Pathway C: Implanted Haemodynamic Monitoring Devices (minimum n=10 participants)
* Uses an implantable device designed to monitor congestion (e.g. CardioMEMS, HeartLogic, or equivalent)
* Enrichment criteria: Patients must also meet a minimum total score of 4 from the characteristics below.

  1. NYHA class III and IV (score: 2)
  2. ≥80 mg/day Furosemide or equivalent loop diuretic (score: 2)
  3. \<3 Number of times the patient has weighed themselves in the last 2 weeks (score: 2)
  4. Help for essential daily activities required (score: 2)
  5. GRMT score \<5 (score: 2)
  6. Use of a walking stick, walker or mobility scooter (score: 2)
  7. \>2 Number of HF events in last 12 months (score: 2)
  8. Aged over 75 (score: 1)
  9. Health issues limiting daily activities (score: 1)
  10. Help getting to medical appointment required (score: 1)
  11. Problematic / not tolerated uptitration of medications:

      MRA (score: 1) SGLT2i (score: 1) Other (score: 1)
  12. English as a second language (score: 1)
  13. eGFR 20-45 (score: 1)
  14. Patient unable to regularly attend appointments for any reason (score: 1)
  15. \>3 Number of co-morbidities (score: 1)

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

Where it's running

• Buckinghamshire Healthcare NHS Trust
  Aylesbury, Buckinghamshire, United Kingdom Recruiting
• Croydon Health Services NHS Trust
  Croydon, Greater London, United Kingdom Recruiting
• Hertfordshire Community NHS Trust
  Welwyn Garden City, Hertfordshire, United Kingdom Recruiting
• Holderness Health
  Patrington, Hull, United Kingdom Recruiting
• Kent Community Health NHS Foundation Trust
  Ashford, Kent, United Kingdom Recruiting
• Lincolnshire Community Health Services NHS Trust
  Lincoln, Lincolnshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Oriane Chausiaux
• Email: me-hf.trial@hftech.org
• Phone: 01223967250

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• NT-proBNP–guided heart failure screening for people 65+ in rural China

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• Voice-based detection of heart failure deterioration using Noah Labs Vox

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  Recruiting Noah Labs · Boston, Massachusetts · NCT07870395

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.