Hokuriku-plus Heart Failure Registry Study　- Rationale and Study Design

Heart failure (HF) is an increasing public health concern in Japan, largely related to the aging population. This protocol describes the rationale, objectives, and methods of the Hokuriku-plus Heart Failure Registry (HpHFR), designed to establish a comprehensive clinical and digital database to assess novel prognostic indicators in patients with HF.

HpHFR is a prospective, multicenter observational cohort study that has enrolled patients with acute or chronic HF from 5 Japanese centers. Eligible patients provided informed consent and underwent baseline clinical, laboratory, and biometric assessment, including digital phonocardiography and wearable device data. Follow-up assessment will be conducted at 4, 12, 26, and 52 weeks. Primary outcomes include all-cause death, HF-related hospitalization, and worsening HF. Secondary outcomes are the changes in clinical parameters over time. A digital substudy will investigate continuous biometric monitoring, and a genomic substudy explores the loss of chromosome Y as a prognostic biomarker.

In conclusion, this study protocol summarizes the development of a valuable prospective cohort resource. This registry will provide a unique dataset enabling multifaceted investigations to improve HF prediction and management by systematically integrating comprehensive clinical and laboratory data with biometric indicators derived from digital devices and genomic markers.