Evaluating Heartfelt’s predictive utility in heart failure: insights from the FOOT multicentre trial

Background Heart failure (HF) poses a global health challenge, with traditional management methods contributing to high readmission and mortality rates. This observational study evaluates the Heartfelt device for remote, autonomous monitoring of peripheral oedema, aiming to improve HF management. Methods Conducted from February 2020 to June 2022 across five UK NHS trusts, the FOOT Study ( NCT04072744 ) enrolled 31 patients, with 26 actively monitored. The study assessed the Heartfelt device’s predictive accuracy, data collection frequency, consistency versus traditional weighing (standard care), lead time for intervention and event prediction sensitivity. Results The Heartfelt device showed a notable lead time of 13 days for HF decompensation prediction, offering more consistent and frequent data than traditional methods. Among the monitored patients, six HF events were observed. Patient feedback was largely positive, with several participants choosing to keep the device poststudy. Conclusions Offering improvements over traditional methods, the Heartfelt device could enhance early HF decompensation detection through continuous oedema monitoring. This study highlights the transformative potential of remote monitoring in HF management, suggesting a need for further research to refine alert systems and assess long-term impacts. Trial registration number NCT04072744 .