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Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial

INTRODUCTION: Sleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates whether bedtime antihypertensive administration, as compared with conventional morning use, reduces major adverse cardiovascular events. ME...

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Autores principales: Garrison, Scott R, Kolber, Michael R, Allan, G Michael, Bakal, Jeffrey, Green, Lee, Singer, Alexander, Trueman, Darryl R, McAlister, Finlay A, Padwal, Raj S, Hill, Michael D, Manns, Braden, McGrail, Kimberlyn, O'Neill, Braden, Greiver, Michelle, Froentjes, Liesbeth S, Manca, Donna P, Mangin, Dee, Wong, Sabrina T, MacLean, Cathy, Kirkwood, Jessica EM, McCracken, Rita, McCormack, James P, Norris, Colleen, Korownyk, Tina
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8883279/
https://www.ncbi.nlm.nih.gov/pubmed/35210352
http://dx.doi.org/10.1136/bmjopen-2021-059711
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author Garrison, Scott R
Kolber, Michael R
Allan, G Michael
Bakal, Jeffrey
Green, Lee
Singer, Alexander
Trueman, Darryl R
McAlister, Finlay A
Padwal, Raj S
Hill, Michael D
Manns, Braden
McGrail, Kimberlyn
O'Neill, Braden
Greiver, Michelle
Froentjes, Liesbeth S
Manca, Donna P
Mangin, Dee
Wong, Sabrina T
MacLean, Cathy
Kirkwood, Jessica EM
McCracken, Rita
McCormack, James P
Norris, Colleen
Korownyk, Tina
author_facet Garrison, Scott R
Kolber, Michael R
Allan, G Michael
Bakal, Jeffrey
Green, Lee
Singer, Alexander
Trueman, Darryl R
McAlister, Finlay A
Padwal, Raj S
Hill, Michael D
Manns, Braden
McGrail, Kimberlyn
O'Neill, Braden
Greiver, Michelle
Froentjes, Liesbeth S
Manca, Donna P
Mangin, Dee
Wong, Sabrina T
MacLean, Cathy
Kirkwood, Jessica EM
McCracken, Rita
McCormack, James P
Norris, Colleen
Korownyk, Tina
author_sort Garrison, Scott R
collection PubMed
description INTRODUCTION: Sleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates whether bedtime antihypertensive administration, as compared with conventional morning use, reduces major adverse cardiovascular events. METHODS AND ANALYSIS: Design Prospective randomised, open-label, blinded end-point trial. Participants Hypertensive primary care patients using blood pressure lowering medication and free from glaucoma. Setting Community primary care providers in 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba and Ontario) are mailing invitations to their eligible patients. Social media campaigns (Google, Facebook) are additionally running in the same provinces. Intervention Consenting participants are allocated via central randomisation to bedtime vs morning use of all antihypertensives. Follow-up (1) Telephone or email questionnaire at 1 week, 6 weeks, 6 months and every 6 months thereafter, and (2) accessing linked governmental healthcare databases tracking hospital and community medical services. Primary outcome Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure. Secondary outcomes Each primary outcome element on its own, all-cause hospitalisation or emergency department visit, long-term care admission, non-vertebral fracture, new glaucoma diagnosis, 18-month cognitive decline from baseline (via Short Blessed Test). Select other outcomes Self-reported nocturia burden at 6 weeks and 6 months (no, minor or major burden), 1-year self-reported overall health score (EQ-5D-5L), self-reported falls, total cost of care (acute and community over study duration) and mean sleep-time systolic blood pressure after 6 months (via 24-hour monitor in a subset of 302 sequential participants). Primary outcome analysis Cox proportional hazards survival analysis. Sample size The trial will continue until a projected 254 primary outcome events have occurred. Current status Enrolment ongoing (3227 randomised to date). ETHICS AND DISSEMINATION: BedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02990663.
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spelling pubmed-88832792022-03-17 Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial Garrison, Scott R Kolber, Michael R Allan, G Michael Bakal, Jeffrey Green, Lee Singer, Alexander Trueman, Darryl R McAlister, Finlay A Padwal, Raj S Hill, Michael D Manns, Braden McGrail, Kimberlyn O'Neill, Braden Greiver, Michelle Froentjes, Liesbeth S Manca, Donna P Mangin, Dee Wong, Sabrina T MacLean, Cathy Kirkwood, Jessica EM McCracken, Rita McCormack, James P Norris, Colleen Korownyk, Tina BMJ Open Cardiovascular Medicine INTRODUCTION: Sleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates whether bedtime antihypertensive administration, as compared with conventional morning use, reduces major adverse cardiovascular events. METHODS AND ANALYSIS: Design Prospective randomised, open-label, blinded end-point trial. Participants Hypertensive primary care patients using blood pressure lowering medication and free from glaucoma. Setting Community primary care providers in 5 Canadian provinces (British Columbia, Alberta, Saskatchewan, Manitoba and Ontario) are mailing invitations to their eligible patients. Social media campaigns (Google, Facebook) are additionally running in the same provinces. Intervention Consenting participants are allocated via central randomisation to bedtime vs morning use of all antihypertensives. Follow-up (1) Telephone or email questionnaire at 1 week, 6 weeks, 6 months and every 6 months thereafter, and (2) accessing linked governmental healthcare databases tracking hospital and community medical services. Primary outcome Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure. Secondary outcomes Each primary outcome element on its own, all-cause hospitalisation or emergency department visit, long-term care admission, non-vertebral fracture, new glaucoma diagnosis, 18-month cognitive decline from baseline (via Short Blessed Test). Select other outcomes Self-reported nocturia burden at 6 weeks and 6 months (no, minor or major burden), 1-year self-reported overall health score (EQ-5D-5L), self-reported falls, total cost of care (acute and community over study duration) and mean sleep-time systolic blood pressure after 6 months (via 24-hour monitor in a subset of 302 sequential participants). Primary outcome analysis Cox proportional hazards survival analysis. Sample size The trial will continue until a projected 254 primary outcome events have occurred. Current status Enrolment ongoing (3227 randomised to date). ETHICS AND DISSEMINATION: BedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02990663. BMJ Publishing Group 2022-02-24 /pmc/articles/PMC8883279/ /pubmed/35210352 http://dx.doi.org/10.1136/bmjopen-2021-059711 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Cardiovascular Medicine
Garrison, Scott R
Kolber, Michael R
Allan, G Michael
Bakal, Jeffrey
Green, Lee
Singer, Alexander
Trueman, Darryl R
McAlister, Finlay A
Padwal, Raj S
Hill, Michael D
Manns, Braden
McGrail, Kimberlyn
O'Neill, Braden
Greiver, Michelle
Froentjes, Liesbeth S
Manca, Donna P
Mangin, Dee
Wong, Sabrina T
MacLean, Cathy
Kirkwood, Jessica EM
McCracken, Rita
McCormack, James P
Norris, Colleen
Korownyk, Tina
Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
title Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
title_full Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
title_fullStr Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
title_full_unstemmed Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
title_short Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
title_sort bedtime versus morning use of antihypertensives for cardiovascular risk reduction (bedmed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
topic Cardiovascular Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8883279/
https://www.ncbi.nlm.nih.gov/pubmed/35210352
http://dx.doi.org/10.1136/bmjopen-2021-059711
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