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Recruiting Not applicable

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

NCT07067658 · tracked via the Priya Life Science UK tracker
Phase
Not applicable
Started
2025-12-18
Last updated
2026-07-28

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Installation of Heartfelt DeviceEnhanced Standard careQuestionnairesHeartfelt device alerting system

Installation of Heartfelt Device: Device installed in the patient's home and capturing foot volume data which are processed in the cloud.

Enhanced Standard care: Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. They should also report changes in breathlessness, tiredness and other symptoms associated with heart failure decompensation. At the start of the study, they will be reminded (or told) about the importance of self-checks and will be handed a patient booklet (from the British Heart Foundation) to standardise patients' knowledge.

Questionnaires: Patients are presented with one or more optional questionnaires (some validated, some bespoke)

Heartfelt device alerting system: The Heartfelt device sends alerts on the active comparator arm to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite Clinical Events — Over 12-months period.
    Unplanned hospital attendance (clinic, emergency, or admission) or death due to heart failure, cardiovascular, respiratory, or renal causes. Recurrent events will be included and adjudicated, providing a comprehensive measure of clinical deterioration over 12 months.
  • Health-Related Quality of Life (EQ-5D-5L) — Collected at baseline, 3, 6, 9, and 12 months
    Patient-reported quality of life measured using EQ-5D-5L, collected at baseline and follow-up (3, 6, 9, 12 months), with primary analysis at 12 months. This validated instrument captures overall health status across five domains and includes a visual analogue scale. * Measured using the EQ-5D-5L index * Collected at baseline, 3, 6, 9, and 12 months. * Primary time point: 12 months. EQ-5D-5L responses will be converted to utility scores on a scale from -0.59 to 1, where 1 represents the best health state, using the UK EQ-5D-5L value set. Patients with at least two or more utility scores during follow-up will be included in the analysis.

Trial sites (18)

FacilityCityRegionStatus
Buckinghamshire Healthcare NHS Trust Aylesbury Buckinghamshire Recruiting
Croydon Health Services NHS Trust Croydon Greater London Recruiting
Hertfordshire Community NHS Trust Welwyn Garden City Hertfordshire Recruiting
Holderness Health Patrington Hull Recruiting
Kent Community Health NHS Foundation Trust Ashford Kent Recruiting
Lincolnshire Community Health Services NHS Trust Lincoln Lincolnshire Recruiting
North Tees & Hartlepool NHS Foundation Trust Hardwick Stockton-on-Tees Recruiting
Ulster Hospital Belfast United Kingdom Not Yet Recruiting
Princess of Wales Hospital Bridgend United Kingdom Recruiting
Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde) Glasgow United Kingdom Recruiting
Hull University Teaching Hospitals NHS Trust Hull United Kingdom Not Yet Recruiting
St George's Hospital London United Kingdom Recruiting
Manchester University NHS Foundation Trust Manchester United Kingdom Recruiting
Milton Keynes University Hospital NHS Foundation Trust Milton Keynes United Kingdom Recruiting
Chilwell Valley and Meadows Practice Nottingham United Kingdom Recruiting
Livewell Southwest Plymouth United Kingdom Not Yet Recruiting
Royal Glamorgan Hospital Pont-y-clun United Kingdom Recruiting
Walsall Manor Hospital Walsall United Kingdom Recruiting

More Heartfelt Technologies trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07067658 on ClinicalTrials.gov ↗ ← All trials in the UK