Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK.
NCT ID: NCT06334822
Last Updated: 2025-11-20
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
270 participants
INTERVENTIONAL
2024-07-11
2026-01-31
Brief Summary
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Fluid retention in the lower legs and lungs, manifesting as swollen ankles and shortness of breath, is a common sign of progressing heart failure. Often, a slight increase in body weight is the first warning of fluid accumulation, occurring before noticeable swelling or breathing issues arise. Early identification of these fluid accumulation signs is critical for timely intervention, which can avert the necessity for hospital admittance. Patients are usually encouraged to monitor their weight, check for swelling in the ankles, observe their breathing, and consult with their healthcare provider or heart failure specialist at the first sign of these symptoms. In many cases, patients can report these symptoms in time for their healthcare team to adjust their treatment accordingly. Diuretics, or water pills, are often prescribed to help eliminate excess fluid, effectively preventing hospital admissions when used promptly.
The Heartfelt device may provide a useful solution for individuals who find it challenging to consistently monitor these indicators and their weight. It is designed to detect early warning signs seamlessly without imposing additional tasks on the patient's daily routine. The device, intended to complement rather than replace self-monitoring practices, is user-friendly and operates by scanning the feet for any size changes, positioned conveniently by the bedroom floor. This capability allows healthcare professionals to make informed decisions swiftly about patient care, potentially adjusting treatments to avoid further health complications. The device captures images of the feet only, ensuring privacy.
This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for patients facing heart failure challenges.
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Detailed Description
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It is a 6 months crossover randomised controlled trial designed to evaluate the effectiveness of the Heartfelt device, a remote patient monitoring system, in reducing the risk of hospitalisation for heart failure (HF) by monitoring peripheral oedema.
We will focus on patients with heart failure who have had at least one hospitalisation for heart failure associated with peripheral oedema in the last year, with stratified randomisation (for the RCT part) to avoid recent discharge effects in the early phases of data collection and focussing on patients considered at high-risk of poor long-term adherence to daily weights (the majority of patients with heart failure). \[8-Fitzgerald\].
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Another 60 patients will have monthly measurements taken at the pharmacy without being part of the main randomisation.
PREVENTION
SINGLE
Study Groups
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Standard Care + Heartfelt device
In addition to standard care activities, participants have the Heartfelt device at home. During this arm, the device sends alerts and measurement data to the patient, carers and clinicians.
Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
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.
Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt device alerting system
The Heartfelt device sends alerts to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.
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.
Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
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.
Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Standard Care + Heartfelt device in pharmacy
Participants will follow standard care advice, and have monthly measurements taken at the pharmacy using the Heartfelt device. The pharmacist will receive the measurements and alerts and be able to communicate this to the participant.
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.
Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt Device in pharmacy
Device used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud.
Interventions
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Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
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.
Questionnaires
Patients are presented with one or more optional questionnaires (some validated, some bespoke)
Heartfelt Device in pharmacy
Device used monthly in the pharmacy, with the assistance of the pharmacist, and capturing foot volume data which are processed in the cloud.
Heartfelt device alerting system
The Heartfelt device sends alerts 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
* Provision of signed and dated informed consent form (e-consent via website or app is acceptable).
* Women or men, aged 18 years or older \[No maximum age\].
* Diagnosis of heart failure at least 3 months previously
* Receiving diuretics on a daily basis
* Peripheral oedema reported on at least one HF-related hospitalisation in the last 4 years (as documented in EPR).
* Hospitalised for HF OR on a Virtual Ward for HF OR has received IV diuretic treatment in the last 12 months, or treated with at least 80 mg furosemide (or equivalent) orally per day.
* For women of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study.
* Is considered by the investigator to be non-adherent OR at high risk of HF hospital readmissions.
Exclusion Criteria
* bandages to lower limbs every day
* amputation of both feet
* regular wheelchair user inside their home
* bed-bound
* no fixed abode
* taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
* Pregnancy or lack of contraceptive measures if of child-bearing potentialâ€
* 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
†This exclusion criterion has been requested by the insurance provider for clinical trial cover.
18 Years
ALL
No
Sponsors
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Heartfelt Technologies
INDUSTRY
Responsible Party
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Locations
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The Ridings Medical Group
Brough, East Riding of Yorkshire, United Kingdom
Dr R Raut & Partnership (General Practice)
Hull, East Riding of Yorkshire, United Kingdom
Croydon Health Services NHS Trust
Croydon, London, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
London, London, United Kingdom
West Suffolk NHS Foundation Trust
Bury St Edmunds, Suffolk, United Kingdom
Modality East Surrey Medical Practice
Horley, Surrey, United Kingdom
Modality Partnership Airedale, Wharfedale & Craven:
Keighley, West Yorkshire, United Kingdom
Pillsorted Ltd
Cambridge, , United Kingdom
Sutton Manor Pharma Services
Hull, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ; Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Circulation. 2018 Feb 27;137(9):961-972. doi: 10.1161/CIRCULATIONAHA.117.033502.
Other Identifiers
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HFT-2024-01
Identifier Type: -
Identifier Source: org_study_id
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