Heart FailureME-HFNCT07067658
Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
A study testing Installation of Heartfelt Device, Questionnaires and Heartfelt device alerting system in people with Heart Failure, run by Heartfelt Technologies at 18 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Installation of Heartfelt Device, Questionnaires and Heartfelt device alerting system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 18 sitesUnited Kingdom
- Study dates
- 18 Dec 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United Kingdom18 sites, 18 recruiting
- Recruiting
Kent Community Health NHS Foundation Trust
Ashford, Kent, TN25 4AZ
Charlotte Marlow, 01987252381, me-hf.trial@hftech.org
Jacqueline Sinnott
- Recruiting
Buckinghamshire Healthcare NHS Trust
Aylesbury, Buckinghamshire, HP21 8AL
James Cooper, 01296 831378, me-hf.trial@hftech.org
Nicola Bowers
- Not yet recruiting
Ulster Hospital
Belfast, BT16 1RH
Dr Patrick Donnelly, 028 9048 4511, me-hf.trial@hftech.org
Patrick Donnelly, Dr
- Recruiting
Princess of Wales Hospital
Bridgend, CF31 1RQ
Gabby Williams, 01443 443443, me-hf.trial@hftech.org
Aaron Wong, Dr
- Recruiting
Croydon Health Services NHS Trust
Croydon, Greater London, CR7 7YE
Baldeep Sidhu, MD, 02084013610, me-hf.trial@hftech.org
Baldeep Sidhu
- Recruiting
Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)
Glasgow, G51 4TF
Pierpaolo Pellicori, Dr, 01412327599, me-hf.trial@hftech.org
Pierpaolo Pellicori, Dr
- Recruiting
North Tees & Hartlepool NHS Foundation Trust
Hardwick, Stockton-on-Tees, TS19 8PE
Karen Hann, 01642 617617, me-hf.trial@hftech.org
Karen Hann
- Not yet recruiting
Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Joe Cuthbert, 01482 875875, me-hf.trial@hftech.org
Joe Cuthbert, Dr
- Recruiting
Lincolnshire Community Health Services NHS Trust
Lincoln, Lincolnshire, LN5 7JH
Katy Ward, 01522572890, me-hf.trial@hftech.org
Alun Roebuck
- Recruiting
St George's Hospital
London, SW17 0QT
Sinead Lyons, 02087254404, me-hf.trial@hftech.org
Robin Ray, Dr
- Recruiting
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Cathy Spence, 01612761234, me-hf.trial@hftech.org
Fozia Ahmed, Dr
- Recruiting
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, MK6 5LD
Soma Hajdu, 01908 660033, me-hf.trial@hftech.org
Attila Kardos, Prof
- Recruiting
Chilwell Valley and Meadows Practice
Nottingham, NG9 6DX
Ed Longridge, 01159462767, me-hf.trial@hftech.org
Kunaal Shah, Dr
- Recruiting
Holderness Health
Patrington, Hull, HU120PH
Joanne Kelly, 01482899111, me-hf.trial@hftech.org
Thobile Nkomo, Dr
- Not yet recruiting
Livewell Southwest
Plymouth, PL6 5DH
Anna Briggs, 01752 435502, me-hf.trial@hftech.org
Anna Briggs
- Recruiting
Royal Glamorgan Hospital
Pont-y-clun, CF72 8XR
Aimee Ibbotson, 01443 443443, me-hf.trial@hftech.org
Karen Knight, 01443 443443
- Recruiting
Walsall Manor Hospital
Walsall, WS2 9PS
Ben Jones, 01922 605792, me-hf.trial@hftech.org
Rumi Jaumdally, Dr
- Recruiting
Hertfordshire Community NHS Trust
Welwyn Garden City, Hertfordshire, AL7 1BW
Gemma Nash, 07407138333, me-hf.trial@hftech.org
Rachel Hards
About this study
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Installation of Heartfelt Device, Enhanced Standard care, Questionnaires, Heartfelt device alerting system
- Keywords
- Peripheral Oedema, Heart Failure Decomposition, Heart Failure Hospitalization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Installation of Heartfelt DeviceDevice
Also called Remote Patient Monitoring Device
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Enhanced Standard careOther
Also called Daily Weighing, Breathlessness, Dizziness, Tiredness
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.
QuestionnairesOther
Also called 5Q-5D, Bespoke Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt device alerting systemDevice
Also called Remote patient monitoring 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Installation of Heartfelt Device; Other: Enhanced Standard care; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Collected at baseline, 3, 6, 9, and 12 months
Secondary outcomes (6)
Days Lost to Hospitalisation or Death
Total number of days lost due to hospitalisation for cardiovascular, respiratory, or renal conditions, or due to all-cause mortality.
Measured: Over 12-months period.
Daily Data Availability
Proportion of days with successful data capture from the Heartfelt device and weighing scales, based on device-generated records or contemporaneous self-report.
Measured: Over 12-months period.
Guideline-Recommended Medication Score
Adherence to guideline-recommended heart failure medications will be assessed using a guideline-recommended medication score, calculated at 3, 6, 9, and 12 months and averaged across these time points. The score is based on the number of eligible medication classes prescribed, with 1 point assigned per class (e.g., ACEi/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist [MRA]). The score ranges from 0 to 3, with 3 being the optimal medication score.
The score is adjusted for patient eligibility: will be calculated only for patients with heart failure with reduced ejection fraction (HFrEF).
Measured: Over 12-months period.
All-Cause Hospitalisations
Number of hospitalisations from any cause, analysed as recurrent events and adjusted for the competing risk of death.
Measured: Over 12-months period.
Loss of Independence or Mortality
Composite measure of new admission to a long-term care facility or all-cause mortality.
Measured: During the 12-month trial period.
Death and Cause of Death
Classification of all deaths recorded during the trial as heart failure-related, other cardiovascular, or non-cardiovascular causes, based on clinical records.
Measured: During 12-months trial period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start18 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This 12-month study involves up to 300 patients using the Heartfelt device at home.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heartfelt Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Manchester University NHS Foundation Trust, University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067658
- Sponsor's protocol ID
- HFT-2025-1
- Acronym
- ME-HF
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will only be shared if approved by the Trial Management Group and that suitable ethics approvals has been received for sharing of such information.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
- ClinicalTrials.gov ID
- NCT07067658
- Acronym / sponsor ID
- ME-HF / HFT-2025-1
- Conditions
- Heart Failure
- Keywords
- Peripheral Oedema, Heart Failure Decomposition, Heart Failure Hospitalization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Heartfelt TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Manchester University NHS Foundation Trust, University of Glasgow
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This 12-month study involves up to 300 patients using the Heartfelt device at home.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard Care + Heartfelt Device | Experimental | Device: Installation of Heartfelt Device, Other: Enhanced Standard care, Other: Questionnaires, Device: Heartfelt device alerting systemHeartfelt 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. |
| Enhanced Standard Care (Control) | Active comparator | Device: Installation of Heartfelt Device, Other: Enhanced Standard care, Other: QuestionnairesIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Installation of Heartfelt DeviceAlso: Remote Patient Monitoring DeviceDevice installed in the patient's home and capturing foot volume data which are processed in the cloud. | Device | Enhanced Standard Care (Control), Enhanced Standard Care + Heartfelt Device |
| Enhanced Standard careAlso: Daily Weighing, Breathlessness, Dizziness, TirednessPatients 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. | Other | Enhanced Standard Care (Control), Enhanced Standard Care + Heartfelt Device |
| QuestionnairesAlso: 5Q-5D, Bespoke QuestionnairesPatients are presented with one or more optional questionnaires (some validated, some bespoke) | Other | Enhanced Standard Care (Control), Enhanced Standard Care + Heartfelt Device |
| Heartfelt device alerting systemAlso: Remote patient monitoring deviceThe 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. | Device | Enhanced Standard Care + Heartfelt Device |
Primary outcome
Composite Clinical Events
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Days Lost to Hospitalisation or Death
Time frame: Over 12-months period.
Daily Data Availability
Time frame: Over 12-months period.
Guideline-Recommended Medication Score
Time frame: Over 12-months period.
All-Cause Hospitalisations
Time frame: Over 12-months period.
Loss of Independence or Mortality
Time frame: During the 12-month trial period.
Death and Cause of Death
Time frame: During 12-months trial period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will only be shared if approved by the Trial Management Group and that suitable ethics approvals has been received for sharing of such information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Installation of Heartfelt Device, Questionnaires and Heartfelt device alerting system in people with Heart Failure, run by Heartfelt Technologies at 18 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriane Chausiaux (01223967250, me-hf.trial@hftech.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Clinical Events (time frame: Over 12-months period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.