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评估估计清醒和睡眠血压的新方法:更好的 BP 研究的设计 - 一项随机、交叉试验。

Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study - a randomised, crossover trial.

机构信息

Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.

Epidemiology, The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama, USA.

出版信息

BMJ Open. 2022 Jun 6;12(6):e058140. doi: 10.1136/bmjopen-2021-058140.

DOI:10.1136/bmjopen-2021-058140
PMID:35667722
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10098258/
Abstract

INTRODUCTION

For many people, blood pressure (BP) levels differ when measured in a medical office versus outside of the office setting. Out-of-office BP has a stronger association with cardiovascular disease (CVD) events compared with BP measured in the office. Many BP guidelines recommend measuring BP outside of the office to confirm the levels obtained in the office. Ambulatory BP monitoring (ABPM) can assess out-of-office BP but is not available in many US practices and some individuals find it uncomfortable. The aims of the Better BP Study are to (1) test if unattended office BP is closer to awake BP on ABPM compared with attended office BP, (2) assess if sleep BP assessed by home BP monitoring (HBPM) agrees with sleep BP from a full night of ABPM and (3) compare the strengths of associations of unattended versus attended office BP, unattended office BP versus awake BP on ABPM and sleep BP on HBPM versus ABPM with markers of end-organ damage.

METHODS AND ANALYSIS

We are recruiting 630 adults not taking antihypertensive medication in Birmingham, Alabama, and New York, New York. Participants are having their office BP measured with (attended) and without (unattended) a technician present, in random order, using an automated oscillometric office BP device during each of two visits within one week. Following these visits, participants complete 24 hours of ABPM and one night of HBPM, in random order. Psychosocial factors, anthropometrics, left ventricular mass index and albumin-to-creatinine ratio are also being assessed.

ETHICS AND DISSEMINATION

This study was approved by the University of Alabama at Birmingham and the Columbia University Medical Center Institutional Review Boards. The study results will be disseminated at scientific conferences and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT04307004.

摘要

简介

对于许多人来说,在医疗办公室内测量的血压(BP)水平与在办公室外测量的血压水平不同。与在办公室内测量的 BP 相比,在办公室外测量的 BP 与心血管疾病(CVD)事件的关联更强。许多 BP 指南建议在办公室外测量 BP,以确认在办公室内获得的 BP 水平。动态血压监测(ABPM)可评估在办公室外的 BP,但在美国的许多实践中并不适用,一些人觉得它不舒服。Better BP 研究的目的是:(1)测试无人值守的办公室 BP 是否比有人值守的办公室 BP 更接近 ABPM 上的清醒 BP;(2)评估通过家庭 BP 监测(HBPM)评估的睡眠 BP 是否与 ABPM 整夜的睡眠 BP 一致;(3)比较无人值守与有人值守的办公室 BP、无人值守的办公室 BP 与 ABPM 上的清醒 BP 以及 HBPM 上的睡眠 BP 与 ABPM 与终末器官损伤标志物的关联强度。

方法和分析

我们正在阿拉巴马州伯明翰和纽约州纽约招募 630 名未服用抗高血压药物的成年人。参与者在两周内的两次就诊中,在无技术员(无人值守)和有技术员(有人值守)在场的情况下,使用自动示波法办公室 BP 设备随机顺序测量其办公室 BP。在这些就诊之后,参与者以随机顺序完成 24 小时 ABPM 和一夜 HBPM。同时还评估了心理社会因素、人体测量学、左心室质量指数和白蛋白与肌酐比值。

伦理和传播

这项研究已获得阿拉巴马大学伯明翰分校和哥伦比亚大学医学中心机构审查委员会的批准。研究结果将在科学会议上公布,并在同行评议期刊上发表。

试验注册号

NCT04307004。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f58/10098258/41c95924da1c/bmjopen-2021-058140f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f58/10098258/41c95924da1c/bmjopen-2021-058140f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9f58/10098258/41c95924da1c/bmjopen-2021-058140f01.jpg

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