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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (18 UK sites)
Buckinghamshire Healthcare NHS Trust
Aylesbury HP21 8AL, United Kingdom
Croydon Health Services NHS Trust
Croydon CR7 7YE, United Kingdom
Hertfordshire Community NHS Trust
Welwyn Garden City AL7 1BW, United Kingdom
Holderness Health
Patrington HU120PH, United Kingdom
Kent Community Health NHS Foundation Trust
Ashford TN25 4AZ, United Kingdom
Lincolnshire Community Health Services NHS Trust
Lincoln LN5 7JH, United Kingdom
North Tees & Hartlepool NHS Foundation Trust
Hardwick TS19 8PE, United Kingdom
Ulster Hospital
Belfast BT16 1RH, United Kingdom
Princess of Wales Hospital
Bridgend CF31 1RQ, United Kingdom
Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)
Glasgow G51 4TF, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull HU3 2JZ, United Kingdom
St George's Hospital
London SW17 0QT, United Kingdom
Manchester University NHS Foundation Trust
Manchester M13 9WL, United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes MK6 5LD, United Kingdom
Chilwell Valley and Meadows Practice
Nottingham NG9 6DX, United Kingdom
Livewell Southwest
Plymouth PL6 5DH, United Kingdom
Royal Glamorgan Hospital
Pont-y-clun CF72 8XR, United Kingdom
Walsall Manor Hospital
Walsall WS2 9PS, United Kingdom
How to Get in Touch
Oriane Chausiaux
Sponsor contactCONTACT
