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] and Benefits of Microcor in Ambulatory Decompensated Heart Failure [BMAD-HF; NCT03476187]).

中文翻译：

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新型可穿戴传感器对心力衰竭再住院的影响：一项开放标签并发对照临床试验。


背景 早期检测心力衰竭失代偿的需求尚未得到满足，允许远程管理患者并避免住院治疗。目的 本研究的目的是比较一种利用可穿戴 HF 传感器数据进行 HF 住院后管理的策略与常规护理。方法 符合条件的受试者在过去 10 天内出院，并且在过去 6 个月内发生过 HF 事件。同步对照研究分为 2 组;对照组 BMAD-HF 和开放标签干预组 BMAD-TX。受试者佩戴 HFMS（心力衰竭监测系统）长达 90 天。BMAD-HF 对照组对研究人员和受试者不知情，但在 BMAD-TX 干预组中主动提供设备数据。通过 Kaplan-Meier 分析首次 HF 住院时间评估 HFMS 管理 HF 的影响。结果 共有 522 名受试者在 93 个地点参加了这项研究。共有 245 名 BMAD-HF 受试者和 249 名 BMAD-TX 受试者符合意向性治疗分析的条件。189 名受试者在 90 天时有 276 例住院，其中 82 例受试者的 108 例事件被确定为心力衰竭相关。与对照组相比，使用 HFMS 数据进行指导 HF 治疗的组受试者在 HF 住院后 90 天内的 HF 住院率降低了 38%（HR = 0.62;P = 0.03）。结论 在近期 HF 住院的患者中，使用 HFMS 数据进行 HF 管理的策略与 90 天 HF 再住院的相对风险降低 38% 相关。 （Microcor 在非卧床失代偿性心力衰竭中的益处 [BMAD-TX;NCT04096040] 和 Microcor 在动态失代偿性心力衰竭中的益处 [BMAD-HF;NCT03476187]）。