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Clinical Trial NCT07067658 (ME-HF) for Heart Failure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk (ME-HF) 300 Novel Treatment
Clinical Trial NCT07067658 (ME-HF) is an interventional study for Heart Failure that is recruiting. It started on 18 December 2025 with plans to enroll 300 participants. Led by Heartfelt Technologies, it is expected to complete by 31 July 2027. The latest data from ClinicalTrials.gov was last updated on 31 December 2025.
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.
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 U...
Show MoreOfficial Title
Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
Conditions
Heart FailureOther Study IDs
- ME-HF
- HFT-2025-1
NCT ID Number
Start Date (Actual)
2025-12-18
Last Update Posted
2025-12-31
Completion Date (Estimated)
2027-07-31
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Peripheral Oedema
Heart Failure Decomposition
Heart Failure Hospitalization
Heart Failure Decomposition
Heart Failure Hospitalization
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalEnhanced 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 patien...Show More 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. |
Active ComparatorEnhanced 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 patien...Show More Questionnaires Patients are presented with one or more optional questionnaires (some validated, some bespoke) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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). | 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. | Over 12-months period. |
Loss of Independence or Mortality | Composite measure of new admission to a long-term care facility or all-cause mortality. | 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. | During 12-months trial period. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Adults >18 years
- 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.
- 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
Heartfelt Technologies- Manchester University NHS Foundation Trust
- University of Glasgow
No contact data.
1 Study Locations in 1 Countries
Greater London
Croydon Health Services NHS Trust, Croydon, Greater London, CR7 7YE, United Kingdom
Baldeep Sidhu, MD, Contact, 020 8401 3000, [email protected]
Recruiting