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PACIFIC-PRESERVED(表型分析、心力衰竭伴射血分数保留患者的心功能障碍分类和创新)研究的原理和设计。

Rationale and design of the PACIFIC-PRESERVED (PhenomApping, ClassIFication and Innovation for Cardiac dysfunction in patients with heart failure and PRESERVED left ventricular ejection fraction) study.

机构信息

Université Paris Cité, INSERM, PARCC, 75015 Paris, France; CIC1418 and DMU CARTE, Hôpital Européen Georges-Pompidou, AP-HP, 75015 Paris, France.

Sanofi R&D, 91380 Chilly-Mazarin, France.

出版信息

Arch Cardiovasc Dis. 2024 May;117(5):332-342. doi: 10.1016/j.acvd.2024.02.011. Epub 2024 Apr 12.

Abstract

BACKGROUND

Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous syndrome that is poorly defined, reflecting an incomplete understanding of its pathophysiology.

AIM

To redefine the phenotypic spectrum of HFpEF.

METHODS

The PACIFIC-PRESERVED study is a prospective multicentre cohort study designed to perform multidimensional deep phenotyping of patients diagnosed with HFpEF (left ventricular ejection fraction≥50%), patients with heart failure with reduced ejection fraction (left ventricular ejection fraction≤40%) and subjects without overt heart failure (3:2:1 ratio). The study proposes prospective investigations in patients during a 1-day hospital stay: physical examination; electrocardiogram; performance-based tests; blood samples; cardiac magnetic resonance imaging; transthoracic echocardiography (rest and low-level exercise); myocardial shear wave elastography; chest computed tomography; and non-invasive measurement of arterial stiffness. Dyspnoea, depression, general health and quality of life will be assessed by dedicated questionnaires. A biobank will be established. After the hospital stay, patients are asked to wear a connected garment (with digital sensors) to collect electrocardiography, pulmonary and activity variables in real-life conditions (for up to 14 days). Data will be centralized for machine-learning-based analyses, with the aim of reclassifying HFpEF into more distinct subgroups, improving understanding of the disease mechanisms and identifying new biological pathways and molecular targets. The study will also serve as a platform to enable the development of innovative technologies and strategies for the diagnosis and stratification of patients with HFpEF.

CONCLUSIONS

PACIFIC-PRESERVED is a prospective multicentre phenomapping study, using novel analytical techniques, which will provide a unique data resource to better define HFpEF and identify new clinically meaningful subgroups of patients.

摘要

背景

射血分数保留的心力衰竭(HFpEF)是一种异质性综合征,定义不明确,反映了对其病理生理学认识的不完整。

目的

重新定义 HFpEF 的表型谱。

方法

PACIFIC-PRESERVED 研究是一项前瞻性多中心队列研究,旨在对诊断为 HFpEF(左心室射血分数≥50%)、射血分数降低的心力衰竭(左心室射血分数≤40%)患者和无明显心力衰竭患者(3:2:1 比例)进行多维深度表型分析。该研究提出了在 1 天住院期间对患者进行前瞻性研究:体格检查;心电图;基于表现的测试;血液样本;心脏磁共振成像;经胸超声心动图(休息和低水平运动);心肌剪切波弹性成像;胸部计算机断层扫描;以及非侵入性动脉僵硬测量。呼吸困难、抑郁、一般健康和生活质量将通过专用问卷进行评估。将建立一个生物库。住院后,要求患者佩戴连接服装(带数字传感器),以在真实条件下(最长 14 天)收集心电图、肺部和活动变量。数据将集中进行基于机器学习的分析,目的是将 HFpEF 重新分类为更明显的亚组,以加深对疾病机制的理解并确定新的生物学途径和分子靶点。该研究还将作为一个平台,使 HFpEF 患者的诊断和分层的创新技术和策略得以发展。

结论

PACIFIC-PRESERVED 是一项前瞻性多中心表型映射研究,使用新的分析技术,将提供独特的数据资源,以更好地定义 HFpEF 并确定新的具有临床意义的患者亚组。

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