Evaluating a device for monitoring heart failure symptoms in the UK.
Randomised Controlled Trial For Assessing The Effectiveness Of An Inclusive Heart Failure Monitoring And Tracking Solution In The UK.(HF-TRACK)
This study is testing a new device that checks foot and leg sizes to see if it can help people with heart failure catch problems early and avoid hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heartfelt Technologies Industry-sponsored |
| Locations | 5 sites (Hull, East Riding Of Yorkshire and 4 other locations) |
| Trial ID | NCT06334822 on ClinicalTrials.gov |
What this trial studies
This research aims to assess the effectiveness of the Heartfelt device, which monitors foot and lower leg sizes to detect early signs of worsening heart failure. The study is a 6-month crossover randomized controlled trial involving patients with a history of heart failure hospitalizations due to peripheral edema. Participants will be monitored for changes in their condition, with the goal of reducing hospital admissions through early detection of fluid retention. The trial is co-designed with input from past users to ensure relevance and usability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of heart failure and a history of hospitalizations related to peripheral edema.
Not a fit: Patients without a recent history of heart failure hospitalizations or those not experiencing peripheral edema may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce hospitalizations for heart failure patients by enabling earlier intervention.
How similar studies have performed: Other studies have shown promise in using remote monitoring devices for heart failure management, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this trial, an individual must meet all of the following 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: An individual who meets any of the following criteria will be excluded from participation in this study: * 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 potential† * 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.
Where this trial is running
Hull, East Riding Of Yorkshire and 4 other locations
- Dr R Raut & Partnership (General Practice) — Hull, East Riding Of Yorkshire, United Kingdom (Recruiting)
- Croydon Health Services NHS Trust — Croydon, London, United Kingdom (Recruiting)
- West Suffolk NHS Foundation Trust — Bury St Edmunds, Suffolk, United Kingdom (Recruiting)
- Pillsorted Ltd — Cambridge, United Kingdom (Recruiting)
- Sutton Manor Pharma Services — Hull, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Oriane E Chausiaux, PhD
- Email: HF-TRACK@hftech.org
- Phone: +44 1223 967250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.