Home Bioelectrical Impedance Analysis Management System in Patients With Heart Failure: Rationale and Study Design

Body fluid monitoring and management are essential to control dyspnea and prevent re-hospitalization in patients with chronic heart failure (HF). There are several methods to estimate and monitor patient's volume status, such as symptoms, signs, body weight, and implantable devices. However, these methods might be difficult to use for reasons that are slow to reflect body water change, inaccurate in specific patients' condition, or invasive. Bioelectrical impedance analysis (BIA) is a novel method for body water monitoring in patients with HF, and the value in prognosis has been proven in previous studies. We aim to determine the efficacy and safety of home BIA body water monitoring-guided HF treatment in patients with chronic HF. This multi-center, open-label, randomized control trial will enroll patients with HF who are taking loop diuretics. The home BIA group patients will be monitored for body water using a home BIA device and receive messages regarding their edema status and direction of additional diuretics usage or behavioral changes through the linked application system once weekly. The control group patients will receive the usual HF management. The primary endpoint is the change in N-terminal prohormone of brain natriuretic peptide levels from baseline after 12 weeks. This trial will provide crucial evidence for patient management with a novel home BIA body water monitoring system in patients with HF.