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Hokuriku-plus Heart Failure Registry Study - Rationale and Study Design
Yasuaki Takeji1, Masaya Shimojima1, Akihiro Nomura1,2,3
1Department of Cardiovascular Medicine, Kanazawa University Graduate School of Medical Sciences Ishikawa Japan.
Insights
The Hokuriku-plus Heart Failure Registry (HpHFR) is a new Japanese study collecting clinical and digital data to find better ways to predict and manage heart failure (HF). This research aims to improve patient outcomes through advanced data analysis.
Area of Science:
- Cardiology
- Public Health
- Biomarkers
Background:
- Heart failure (HF) presents a growing public health challenge in Japan, exacerbated by an aging demographic.
- The Hokuriku-plus Heart Failure Registry (HpHFR) protocol is detailed herein.
- The registry aims to create a comprehensive clinical and digital database for identifying novel prognostic indicators in HF patients.
Purpose of the Study:
- To establish a prospective, multicenter observational cohort study in Japan.
- To enroll patients with acute or chronic heart failure (HF).
- To assess novel prognostic indicators for HF using integrated clinical, digital, and genomic data.
Main Methods:
- Prospective, multicenter observational cohort study involving 5 Japanese centers.
- Baseline assessments included clinical, laboratory, and biometric data, with digital phonocardiography and wearable device integration.
- Follow-up assessments scheduled at 4, 12, 26, and 52 weeks, with primary outcomes of all-cause death, HF hospitalization, and HF worsening.
Main Results:
- The study enrolled patients with acute or chronic heart failure (HF).
- Data collection includes clinical, laboratory, biometric, digital phonocardiography, and wearable device information.
- Primary outcomes focus on mortality, hospitalization, and HF exacerbation, with secondary outcomes on clinical parameter changes.
Conclusions:
- The HpHFR protocol outlines the creation of a valuable prospective cohort resource.
- The registry will yield a unique dataset for multifaceted investigations into HF prediction and management.
- Integration of clinical, laboratory, digital biometric, and genomic data aims to improve HF care.
Background:
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.
Methods And Results:
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.
Conclusions:
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.
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