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

Other illness

• Inability to provide informed consent due to cognitive impairment
• Patients with severe aortic stenosis or awaiting a heart procedure or surgery

Lab values

• Patient with end stage renal disease (eGFR \<20)

Other

• 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
• 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.
• Pregnancy or lack of contraceptive measures if of child-bearing potential

• 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:
  • 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.
  • NYHA class III and IV (score: 2)
  • ≥80 mg/day Furosemide or equivalent loop diuretic (score: 2)
  • \<3 Number of times the patient has weighed themselves in the last 2 weeks (score: 2)
  • Help for essential daily activities required (score: 2)
  • GRMT score \<5 (score: 2)
  • Use of a walking stick, walker or mobility scooter (score: 2)
  • \>2 Number of HF events in last 12 months (score: 2)
  • Aged over 75 (score: 1)
  • Health issues limiting daily activities (score: 1)
  • Help getting to medical appointment required (score: 1)
  • Problematic / not tolerated uptitration of medications:
  • MRA (score: 1) SGLT2i (score: 1) Other (score: 1)
  • English as a second language (score: 1)
  • eGFR 20-45 (score: 1)
  • Patient unable to regularly attend appointments for any reason (score: 1)
  • \>3 Number of co-morbidities (score: 1)