The HEARTFELT Study — HEARTFELT  

Heart Failure Clinical Trial

Official title: A Pragmatic, Single-blind, Randomized Crossover Trial Testing the Effectiveness of Autonomous Remote Patient Peripheral Edema Monitoring and Alerting in HEART FailurE Compared to conventionaL remoTe Patient Monitoring.

Status Not yet recruiting

Clinical Trial Summary

This study looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the formation of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce unscheduled hospitalizations for the management of worsening HF (HFHs). Patients will be recruited through Remote Patient Monitoring Companies (RPMC) based in the US, using crossover stratified randomization between standard care, Heartfelt device usage with health alerts sent to RPMC and Heartfelt device usage with alerts sent to RPMC as well as on-device alerts in the patient's home.

Clinical Trial Description

The hypothesis for this study is that the Heartfelt device can reliably capture foot volume data in patient's home and that this data can be used to monitor patients remotely, ultimately reducing the risk of HF hospitalization. This is the pivotal trial for the device in the USA. The study design is a nested crossover randomization between: - Standard care (control), 162 days: The device is installed in the home and captures data but no health alerts are sent, and the RPMC does not receive measurement data from the device. Measurement data and health alerts are generated and stored for review at the end of the study period to correlate with health issues which occurred during usual care. - Standard care + Heartfelt (intervention), 162 days: A nested cross of the following interventions - Direct to patient health alerts, 54 days: The device captures data and alerts are presented to patients/family on the app/SMS/email as well as by voice health alerts on the device. The device does not transmit measurement data or health alerts to the RPMC for review. - RPMC care only, 54 days: The device captures data and transmits volume measurements and health alerts to the RPMC for review. No direct-to-patient health alerts are generated. - RPMC + Direct-to-patient health alerts, 54 days: The device captures data and transmits volume measurements and health alerts to the RPMC for review. Health alerts are presented to patients/family on the app/SMS/email as well as by voice health alerts on the device. Total study length is 366 days (days 0 to 365). There is a 21-day "washout" for days 0-20 and days 183-203. The "washout" period has the device configured to match the period following the "washout". There is no "washout" between each distinct intervention mode. Date of installation will use stratified random sampling up to 4 months post-consent date for installation month (ensuring at least 3 months since the most recent hospital discharge at the time of screening). At the completion of both crossover arms, patients will be offered the opportunity to keep the device for as long as the study remains active (potentially up to an additional 4 years, for those patients recruited early in the study). During this long-term follow-up, the device will be placed in "RPMC + Direct-to-patient health alerts" mode (intervention), with randomized 100-day periods where the device is switched into "Standard care" mode (control), not closer than 170 days from the end of one control interval to the beginning of the next. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT06222099
• Study type: Interventional
• Source: Heartfelt Technologies
• Contact: WH Wilson Tang, MD
• Phone: +441223 967250
• Email: usa.trial@hftech.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Completion date: September 30, 2029