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多中心射血分数保留的心力衰竭精确诊断算法研究(STOP-HFPEF研究):研究方案与设计

The Multicenter STudy On a Precise algorithm for diagnosis of heart failure with preserved ejection fraction, STOP-HFPEF study: study protocol and design.

作者信息

Sugimoto Tadafumi, Kawada Yu, Kikuchi Shohei, Kitada Shuichi, Daimon Masao, Hirano Yutaka, Izumo Masaki, Onishi Toshinari, Obokata Masaru, Utsunomiya Hiroto, Seo Yoshihiro

机构信息

Departments of Cardiology, Nagoya City University Mirai Kousei Hospital, 2-1501 Sekobou, Nagoya, 465-8650, Japan.

Department of Cardiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuhocho, Nagoya, 467-8601, Japan.

出版信息

J Echocardiogr. 2025 Mar;23(1):19-23. doi: 10.1007/s12574-024-00655-x. Epub 2024 Aug 5.

DOI:10.1007/s12574-024-00655-x
PMID:39102170
Abstract

This study aims to develop a new heart failure with preserved ejection fraction (HFpEF) diagnostic algorithm tailored to Asian populations, addressing limitations of current diagnostic models. Existing HFpEF diagnostic algorithms primarily target patients with dyspnea and metabolic comorbidities, such as obesity, which are more prevalent in Western populations. However, in Asian countries, HFpEF cases are less frequently associated with obesity, leading to less prominent dyspnea and more noticeable symptoms such as fatigue. By incorporating exercise stress echocardiography and focusing on early-stage HFpEF, particularly in patients with symptoms beyond dyspnea, we seek to enable early diagnosis and intervention, ultimately extending healthy life expectancy and improving quality of life. The STOP-HFPEF (The Multicenter STudy On a Precise algorithm for diagnosis of Heart Failure with Preserved Ejection Fraction) study is a multicenter prospective observational investigation in Japan. Certified by the Japanese Society of Echocardiography, the study includes participants aged 20 and older who undergo exercise stress echocardiography. The primary goal is to develop a scoring model for diagnosing HFpEF in heart-failure stages A, B, and C. Secondary outcomes will assess the clinical utility of the new diagnostic score by comparing heart-failure incidence, cardiovascular events, and mortality rates.Study registration: Registered at the UMIN registry (UMIN000054565) on 1 July 2024.

摘要

本研究旨在开发一种针对亚洲人群量身定制的射血分数保留的心力衰竭(HFpEF)诊断新算法,以解决当前诊断模型的局限性。现有的HFpEF诊断算法主要针对有呼吸困难和代谢合并症(如肥胖)的患者,这些情况在西方人群中更为普遍。然而,在亚洲国家,HFpEF病例与肥胖的关联较少,导致呼吸困难不那么突出,而疲劳等症状更为明显。通过纳入运动负荷超声心动图并关注早期HFpEF,特别是有呼吸困难以外症状的患者,我们力求实现早期诊断和干预,最终延长健康预期寿命并提高生活质量。STOP-HFPEF(射血分数保留的心力衰竭精确诊断算法多中心研究)研究是在日本进行的一项多中心前瞻性观察性调查。该研究经日本超声心动图学会认证,纳入20岁及以上接受运动负荷超声心动图检查的参与者。主要目标是开发一种用于诊断A、B和C期心力衰竭中HFpEF的评分模型。次要结果将通过比较心力衰竭发病率、心血管事件和死亡率来评估新诊断评分的临床效用。研究注册:于2024年7月1日在UMIN注册中心(UMIN000054565)注册。

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How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).如何诊断射血分数保留的心力衰竭:HFA-PEFF 诊断算法:欧洲心脏病学会(ESC)心力衰竭协会(HFA)的共识推荐。
Eur Heart J. 2019 Oct 21;40(40):3297-3317. doi: 10.1093/eurheartj/ehz641.
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A Simple, Evidence-Based Approach to Help Guide Diagnosis of Heart Failure With Preserved Ejection Fraction.一种简单、基于证据的方法,有助于指导射血分数保留的心力衰竭的诊断。
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