Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
NCT ID: NCT07067658
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-12-18
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Enhanced Standard Care + Heartfelt Device
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.
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.
Enhanced Standard Care (Control)
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.
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)
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of heart failure (any aetiology or left ventricular ejection fraction classification), any timeframe
* Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic) for at least one month.
* Heart failure hospital admission and moderate or severe leg oedema in the previous 12 months.
* Lives in the UK, with a home environment suitable for installation of the Heartfelt device.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
University of Glasgow
OTHER
Heartfelt Technologies
INDUSTRY
Responsible Party
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Locations
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Croydon Health Services NHS Trust
Croydon, Greater London, United Kingdom
Countries
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Facility Contacts
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Baldeep Sidhu, MD
Role: primary
Other Identifiers
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HFT-2025-1
Identifier Type: -
Identifier Source: org_study_id