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中国心力衰竭患者门诊外血压测量登记研究(OOBPM-HF研究):研究方案、原理与设计

Out-of-Office Blood Pressure Measurements in Patients with Heart Failure Registry Study (OOBPM-HF study) in China: study protocol, rationale and design.

作者信息

Miao Huanhuan, Zhou Zhanyang, Yin Zheng, Li Xue, Zhang Jian, Zhang Yuqing

机构信息

State Key Laboratory of Cardiovascular Disease, Heart Failure Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

State Key Laboratory of Cardiovascular Disease, Heart Failure Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China

出版信息

BMJ Open. 2025 Sep 4;15(9):e100482. doi: 10.1136/bmjopen-2025-100482.

Abstract

BACKGROUND

The optimal blood pressure (BP) target for patients with heart failure (HF) remains a topic of debate. The relationship between out-of-office BP measurements and the prognosis of HF patients is still unclear. However, there is a lack of large-scale studies investigating out-of-office BP levels in Chinese populations with HF. This study aims to outline the rationale and design of the Out-of-Office Blood Pressure Measurements in Patients with Heart Failure registry (OOBPM-HF) study in China.

METHODS

The OOBPM-HF study is a prospective, multicentre, observational cohort study involving participants recruited from 26 hospitals in China. Patents with relatively stable HF symptoms will undergo a screening process to determine their eligibility for study participation. Data from baseline clinical, laboratory and imaging examinations will be collected. BP parameters, including office BP, ambulatory BP and home BP, will be measured and documented. The primary endpoint of the study is the composite endpoint of death from cardiovascular causes and HF hospitalisation. Participants will be followed up for a duration of 18 months.

CONCLUSIONS

The study will establish a comprehensive understanding of the associations between out-of-office BP measurements and HF prognosis within the Chinese population. The findings of this study will provide valuable insights into the optimal BP range for patients with HF and will contribute to the management of BP in this patient group.

TRIAL REGISTRATION NUMBER

ChiCTR2400090786; Result.

摘要

背景

心力衰竭(HF)患者的最佳血压(BP)目标仍是一个有争议的话题。门诊外血压测量与HF患者预后之间的关系仍不清楚。然而,缺乏针对中国HF人群门诊外血压水平的大规模研究。本研究旨在概述中国心力衰竭患者门诊外血压测量登记研究(OOBPM-HF)的基本原理和设计。

方法

OOBPM-HF研究是一项前瞻性、多中心、观察性队列研究,涉及从中国26家医院招募的参与者。有相对稳定HF症状的患者将接受筛查,以确定其参与研究的资格。将收集基线临床、实验室和影像学检查的数据。将测量并记录包括诊室血压、动态血压和家庭血压在内的血压参数。该研究的主要终点是心血管原因死亡和HF住院的复合终点。参与者将被随访18个月。

结论

该研究将全面了解中国人群门诊外血压测量与HF预后之间的关联。本研究的结果将为HF患者的最佳血压范围提供有价值的见解,并将有助于该患者群体的血压管理。

试验注册号

ChiCTR2400090786;结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8605/12414197/e475540a004a/bmjopen-15-9-g001.jpg

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