Randomised Controlled Trial for Assessing the Effectiveness of an Inclusive Heart Failure Monitoring and TRACKing Solution in the UK. - Trial NCT06334822

Timeline & Enrollment

Primary Outcome

All-Cause Mortality Rate.,Heart Failure Hospitalisation Incidence.,Device-Related Complication Rate.

Summary

The objective of our research is to evaluate the effectiveness of an innovative medical
 device designed to measure foot and lower leg sizes in detecting early indications of
 deteriorating heart failure. This health condition frequently causes leg swelling and
 breathing difficulties due to fluid accumulation. Early detection of these symptoms is vital
 for effective management, potentially preventing the need for hospitalization.
 
 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.

ICD-10 Classifications