Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial

Abstract

Background: There is an unmet need for early detection of heart failure decompensation, allowing patients to be managed remotely and avoid hospitalization.

Objectives: The purpose of this study was to compare a strategy utilizing data from a wearable HF sensor for management following a HF hospitalization to usual care.

Methods: Eligible subjects were discharged from the hospital within the previous 10 days and had a HF event in the previous 6 months. The concurrent control study was divided into 2 arms; a control arm, BMAD-HF and an open-label intervention arm, BMAD-TX. The HFMS (Heart Failure Monitoring System) was worn by subjects for up to 90 days. Device data was blinded to investigators and subjects in the BMAD-HF control arm but provided proactively in the BMAD-TX intervention arm. The impact of HF management with the HFMS was evaluated by Kaplan-Meier analysis of time to first HF hospitalization.

Results: A total of 522 subjects were enrolled in the study at 93 sites. A total of 245 subjects in BMAD-HF and 249 in BMAD-TX were eligible for intention-to-treat analysis. There were 276 hospitalizations in 189 subjects at 90 days, of which 108 events were determined to be heart failure related in 82 subjects. The subjects in the arm managed using HFMS data to direct HF therapy had a 38% lower HF hospitalization rate during the 90 days following a HF hospitalization compared to subjects in the control arm (HR: 0.62; P = 0.03).

Conclusions: In patients with a recent HF hospitalization, a strategy of using HFMS data for HF management is associated with a 38% relative risk reduction in 90-day HF rehospitalization. (Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-TX]; NCT04096040; Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-HF]; NCT03476187).

Keywords: heart failure; heart failure hospitalization; heart failure remote monitoring; total body fluid monitoring; wearables.