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

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...

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Main Authors: Paul Muntner, Ligong Chen, Daichi Shimbo, Joseph E Schwartz, Maria Cepeda, Demetria Hubbard, Suzanne Oparil, Byron C Jaeger, Shakia T Hardy, Julia Medina
Format: Article
Language:English
Published: BMJ Publishing Group 2022-06-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/6/e058140.full
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author Paul Muntner
Ligong Chen
Daichi Shimbo
Joseph E Schwartz
Maria Cepeda
Demetria Hubbard
Suzanne Oparil
Byron C Jaeger
Shakia T Hardy
Julia Medina
author_facet Paul Muntner
Ligong Chen
Daichi Shimbo
Joseph E Schwartz
Maria Cepeda
Demetria Hubbard
Suzanne Oparil
Byron C Jaeger
Shakia T Hardy
Julia Medina
author_sort Paul Muntner
collection DOAJ
description 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.
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spelling doaj-art-2f76555343ba46c6b6efde67379861042025-02-01T10:10:13ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-058140Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study – a randomised, crossover trialPaul Muntner0Ligong Chen1Daichi Shimbo2Joseph E Schwartz3Maria Cepeda4Demetria Hubbard5Suzanne Oparil6Byron C Jaeger7Shakia T Hardy8Julia Medina9School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA2 Biostatistician, The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama, USADivision of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York City, New York, USA15 Center for Behavioral Cardiovascular Health, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA1 Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA2 Epidemiology, The University of Alabama at Birmingham School of Public Health, Birmingham, Alabama, USA1University of Alabama at Birmingham, Birmingham, United States of America6 Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA7 Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA8 Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USAIntroduction 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.https://bmjopen.bmj.com/content/12/6/e058140.full
spellingShingle Paul Muntner
Ligong Chen
Daichi Shimbo
Joseph E Schwartz
Maria Cepeda
Demetria Hubbard
Suzanne Oparil
Byron C Jaeger
Shakia T Hardy
Julia Medina
Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study – a randomised, crossover trial
BMJ Open
title Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study – a randomised, crossover trial
title_full Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study – a randomised, crossover trial
title_fullStr Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study – a randomised, crossover trial
title_full_unstemmed Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study – a randomised, crossover trial
title_short Evaluating novel approaches for estimating awake and sleep blood pressure: design of the Better BP Study – a randomised, crossover trial
title_sort evaluating novel approaches for estimating awake and sleep blood pressure design of the better bp study a randomised crossover trial
url https://bmjopen.bmj.com/content/12/6/e058140.full
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