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Observational Study
. 2020 Sep 10;10(9):e038623.
doi: 10.1136/bmjopen-2020-038623.

Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design

Hayato Tada  1 , Hirofumi Okada  2 , Shohei Yoshida  2 , Masaya Shimojima  2 , Akihiro Nomura  2 , Toyonobu Tsuda  2 , Mika Mori  2 , Shin-Ichiro Takashima  2 , Takeshi Kato  2 , Soichiro Usui  2 , Kenji Sakata  2 , Kenshi Hayashi  2 , Noboru Fujino  2 , Akihiro Inazu  3 , Shizuko Takahara  4 , Yasuhito Imai  4 , Takao Matsubara  5 , Atsushi Nohara  5 , Kenji Miwa  5 , Masanobu Namura  6 , Hidenobu Terai  6 , Taiji Yoshida  6 , Tsutomu Araki  7 , Masahiro Minamoto  8 , Toru Aburao  8 , Yuji Ito  9 , Chiaki Nakanishi  9 , Suguru Kawasaki  10 , Yasuhiro Todo  11 , Junji Koizumi  12 , Yoshihito Kita  13 , Hiroshi Matsumoto  13 , Hiroaki Shintaku  13 , Akihiko Hodatsu  14 , Hidekazu Ino  15 , Toshinori Higashikata  16 , Mutsuko Takata  16 , Katsushi Misawa  17 , Masato Yamaguchi  18 , Yoshihiro Noji  18 , Kazuo Osato  19 , Tomohito Mabuchi  19 , Taro Ichise  19 , Bunji Kaku  20 , Shoji Katsuda  20 , Manabu Fujimoto  21 , Katsuharu Uchiyama  21 , Kensuke Fujioka  21 , Takuya Nakahashi  22 , Tsuyoshi Nozue  23 , Ichiro Michishita  23 , Kazuo Usuda  24 , Kanichi Otowa  24 , Kazuyasu Okeie  25 , Satoshi Hirota  26 , Isao Aburadani  26 , Keisuke Kurokawa  27 , Osamu Takatori  27 , Shunichiro Hondo  28 , Hiroyuki Oda  28 , Shigeo Takata  29 , Hisayoshi Murai  29 , Masaki Kinoshita  30 , Hideo Nagai  31 , Yoshiteru Sekiguchi  31 , Satoru Sakagami  32 , Wataru Omi  32 , Chikara Fujita  33 , Tatsuo Katsuki  33 , Hiroshi Ootsuji  34 , Atsushi Igarashi  34 , Manabu Nakano  35 , Seiichiro Okura  36 , Koji Maeno  36 , Yasuhito Mitamura  37 , Naoki Sugimoto  38 , Masakazu Yamamoto  39 , Hironobu Akao  40 , Kouji Kajinami  40 , Masayuki Takamura  2 , Masa-Aki Kawashiri  2
Affiliations
Observational Study

Hokuriku-plus familial hypercholesterolaemia registry study: rationale and study design

Hayato Tada et al. BMJ Open. .

Abstract

Introduction: Familial hypercholesterolaemia (FH) is an autosomal-dominant inherited genetic disease. It carries an extremely high cardiovascular risk associated with significantly elevated low-density lipoprotein (LDL) cholesterol. The diagnostic rate of this disease in some European nations is quite high, due to the presence of multiple prospective registries. On the other hand, few data-and in particular multicentre data-exist regarding this issue among Japanese subjects. Therefore, this study intends to assemble a multicentre registry that aims to comprehensively assess cardiovascular risk among Japanese FH patients while taking into account their genetic backgrounds.

Methods and analysis: The Hokuriku-plus FH registry is a prospective, observational, multicentre cohort study, enrolling consecutive FH patients who fulfil the clinical criteria of FH in Japan from 37 participating hospitals mostly in Hokuriku region of Japan from April 2020 to March 2024. A total of 1000 patients will be enrolled into the study, and we plan to follow-up participants over 5 years. We will collect clinical parameters, including lipids, physical findings, genetic backgrounds and clinical events covering atherosclerotic and other important events, such as malignancies. The primary endpoint of this study is new atherosclerotic cardiovascular disease (ASCVD) events. The secondary endpoints are as follows: LDL cholesterol, secondary ASCVD events and the occurrence of other diseases including hypertension, diabetes and malignancies.

Ethics and dissemination: This study is being conducted in compliance with the Declaration of Helsinki, the Ethical Guidelines for Medical and Health Research Involving Human Subjects, and all other applicable laws and guidelines in Japan. This study protocol has been approved by the Institutional Review Board at Kanazawa University. We will disseminate the final results at international conferences and in a peer-reviewed journal.

Trial registration number: UMIN000038210.

Keywords: adult cardiology; genetics; lipid disorders.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Participating study centres, including 37 hospitals across the Hokuriku region of Japan Blue circles indicate the hospitals participating in this study. Thirty-one of the 37 hospitals are located in the Hokuriku region of Japan and one hospital is located in the Tokyo area.
See this image and copyright information in PMC

References

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