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

NCT07067658 | Recruiting

• 1 other identifier: HFT-2025-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 18

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 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

Heart Failure

Keywords

Peripheral Oedema; Heart Failure Decomposition; Heart Failure Hospitalization

Outcome Measures

Primary Outcomes (2)

• Composite Clinical Events

  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.

  Over 12-months period.

• Health-Related Quality of Life (EQ-5D-5L)

  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.

  Collected at baseline, 3, 6, 9, and 12 months

Secondary Outcomes (6)

• Days Lost to Hospitalisation or Death

  Over 12-months period.

• Daily Data Availability

  Over 12-months period.

• Guideline-Recommended Medication Score

  Over 12-months period.

• All-Cause Hospitalisations

  Over 12-months period.

• Loss of Independence or Mortality

  During the 12-month trial period.

Study Arms (2)

Enhanced Standard Care + Heartfelt Device

EXPERIMENTAL

Heartfelt device's camera-based system passively measures foot and leg swelling each day as participants walk past it. Patients in this experimental control arm will not receive health alerts from the Heartfelt device, though data will still be passively collected. Patients will also be provided with the British Heart Foundation patient booklet to improve their understanding and self-monitoring of the disease.

Device: Installation of Heartfelt Device; Other: Enhanced Standard care; Other: Questionnaires; Device: Heartfelt device alerting system

Enhanced Standard Care (Control)

ACTIVE COMPARATOR

In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians. Patients will also be provided with the British Heart Foundation patient booklet to improve their understanding and self-monitoring of the disease.

Device: Installation of Heartfelt Device; Other: Enhanced Standard care; Other: Questionnaires

Interventions

Enhanced Standard care OTHER

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.

Also known as: Daily Weighing, Breathlessness, Dizziness, Tiredness

Enhanced Standard Care (Control); Enhanced Standard Care + Heartfelt Device

Installation of Heartfelt Device DEVICE

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

Also known as: Remote Patient Monitoring Device

Enhanced Standard Care (Control); Enhanced Standard Care + Heartfelt Device

Questionnaires OTHER

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

Also known as: 5Q-5D, Bespoke Questionnaires

Enhanced Standard Care (Control); Enhanced Standard Care + Heartfelt Device

Heartfelt device alerting system DEVICE

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.

Also known as: Remote patient monitoring device

Enhanced Standard Care + Heartfelt Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• NYHA class III and IV (score: 2)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Glasgow: collaborator
• Heartfelt Technologies: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (18)

Buckinghamshire Healthcare NHS Trust

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

RECRUITING

Croydon Health Services NHS Trust

Croydon, Greater London, CR7 7YE, United Kingdom

RECRUITING

Hertfordshire Community NHS Trust

Welwyn Garden City, Hertfordshire, AL7 1BW, United Kingdom

RECRUITING

Holderness Health

Patrington, Hull, HU120PH, United Kingdom

RECRUITING

Kent Community Health NHS Foundation Trust

Ashford, Kent, TN25 4AZ, United Kingdom

RECRUITING

Lincolnshire Community Health Services NHS Trust

Lincoln, Lincolnshire, LN5 7JH, United Kingdom

RECRUITING

North Tees & Hartlepool NHS Foundation Trust

Hardwick, Stockton-on-Tees, TS19 8PE, United Kingdom

RECRUITING

Ulster Hospital

Belfast, BT16 1RH, United Kingdom

NOT YET RECRUITING

Princess of Wales Hospital

Bridgend, CF31 1RQ, United Kingdom

RECRUITING

Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)

Glasgow, G51 4TF, United Kingdom

RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

NOT YET RECRUITING

St George's Hospital

London, SW17 0QT, United Kingdom

RECRUITING

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, MK6 5LD, United Kingdom

RECRUITING

Chilwell Valley and Meadows Practice

Nottingham, NG9 6DX, United Kingdom

RECRUITING

Livewell Southwest

Plymouth, PL6 5DH, United Kingdom

NOT YET RECRUITING

Royal Glamorgan Hospital

Pont-y-clun, CF72 8XR, United Kingdom

RECRUITING

Walsall Manor Hospital

Walsall, WS2 9PS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Oriane Chausiaux

CONTACT

01223967250; me-hf.trial@hftech.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and care providers will be blinded, thus will not know whether patients are in the control or intervention arm.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This 12-month study involves up to 300 patients using the Heartfelt device at home.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 16, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

GB (18)