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

Sponsor: Heartfelt Technologies

NCT ID: NCT07067658

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Installation of Heartfelt Device (device), Enhanced Standard care (other), Questionnaires (other), Heartfelt device alerting system (device)
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
Installation of Heartfelt Device — device: Device installed in the patient's home and capturing foot volume data which are processed in the cloud. · Enhanced Standard care — other: Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. · Questionnaires — other: Patients are presented with one or more optional questionnaires (some validated, some bespoke) · 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
300
Started
2025-12-18
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • NA - 300 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure

Where?

  • • Aylesbury - Buckinghamshire Healthcare NHS Trust
  • • Croydon - Croydon Health Services NHS Trust
  • • Welwyn Garden City - Hertfordshire Community NHS Trust
  • • Patrington - Holderness Health
  • • +14 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Heart failure often causes fluid build-up in the legs and lungs, leading to symptoms like swelling and breathlessness. Spotting these signs early is important to help prevent worsening health and hospital admissions. While patients are encouraged to monitor their weight and symptoms, this can be hard to keep up with. The study will involve 300 participants from at least 15 NHS hospitals and GP practices across the UK. People will be randomly placed into one of two groups: one will receive standard NHS care (including regular weight checks and symptom monitoring), and the other will receive the same care plus the Heartfelt device. The trial is partly blinded: participants may see technical messages (e.g. if the device goes offline), but only the group using the device will trigger clinical alerts. The Heartfelt device takes daily images of the feet to track changes in size, without the need for any extra effort from the user. If important changes are spotted, alerts are sent to the clinical team so they can act quickly. The study will look at quality of life, how often the device sends useful data, healthcare use, and how teams respond to alerts. It will also explore how easy the device is to use and whether it offers good value for money. Patients will help shape the study to make sure the findings are relevant and useful for future care.

Heart Failure

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ (score: 2)
  • ✓ (score: 1)

What the study is looking for

  • ✓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

Who cannot take part

  • ✗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
See the full criteria
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 Is This Study? (18 UK sites)

Buckinghamshire Healthcare NHS Trust

Aylesbury HP21 8AL, United Kingdom

Recruiting
Site contact (verified)
Nicola BowersPrincipal Investigator

Croydon Health Services NHS Trust

Croydon CR7 7YE, United Kingdom

Recruiting
Site contact (verified)
Baldeep SidhuPrincipal Investigator

Hertfordshire Community NHS Trust

Welwyn Garden City AL7 1BW, United Kingdom

Recruiting
Site contact (verified)
Rachel HardsPrincipal Investigator

Holderness Health

Patrington HU120PH, United Kingdom

Recruiting
Site contact (verified)
Thobile Nkomo, DrPrincipal Investigator

Kent Community Health NHS Foundation Trust

Ashford TN25 4AZ, United Kingdom

Recruiting
Site contact (verified)
Jacqueline SinnottPrincipal Investigator

Lincolnshire Community Health Services NHS Trust

Lincoln LN5 7JH, United Kingdom

Recruiting
Site contact (verified)
Alun RoebuckPrincipal Investigator

North Tees & Hartlepool NHS Foundation Trust

Hardwick TS19 8PE, United Kingdom

Recruiting
Site contact (verified)
Karen HannPrincipal Investigator

Ulster Hospital

Belfast BT16 1RH, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Patrick Donnelly, DrPrincipal Investigator

Princess of Wales Hospital

Bridgend CF31 1RQ, United Kingdom

Recruiting
Site contact (verified)
Aaron Wong, DrPrincipal Investigator

Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Pierpaolo Pellicori, DrPrincipal Investigator
Pierpaolo Pellicori, Dr01412327599me-hf.trial@hftech.org

Hull University Teaching Hospitals NHS Trust

Hull HU3 2JZ, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Joe Cuthbert, DrPrincipal Investigator

St George's Hospital

London SW17 0QT, United Kingdom

Recruiting
Site contact (verified)
Robin Ray, DrPrincipal Investigator

Manchester University NHS Foundation Trust

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)
Fozia Ahmed, DrPrincipal Investigator

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes MK6 5LD, United Kingdom

Recruiting
Site contact (verified)
Attila Kardos, ProfPrincipal Investigator

Chilwell Valley and Meadows Practice

Nottingham NG9 6DX, United Kingdom

Recruiting
Site contact (verified)
Kunaal Shah, DrPrincipal Investigator

Livewell Southwest

Plymouth PL6 5DH, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Anna BriggsPrincipal Investigator

Royal Glamorgan Hospital

Pont-y-clun CF72 8XR, United Kingdom

Recruiting
Site contact (verified)
Aimee IbbotsonPrincipal Investigator
Karen Knight01443 443443

Walsall Manor Hospital

Walsall WS2 9PS, United Kingdom

Recruiting
Site contact (verified)
Rumi Jaumdally, DrPrincipal Investigator

How to Get in Touch

Oriane Chausiaux

Sponsor contact

CONTACT

01223967250 me-hf.trial@hftech.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-07