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

IntroductionSleep-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.Metho...

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Published inBMJ open Vol. 12; no. 2; p. e059711
Main Authors 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
Format Journal Article
LanguageEnglish
Published England British Medical Journal Publishing Group 24.02.2022
BMJ Publishing Group LTD
BMJ Publishing Group
SeriesProtocol
Subjects
Alberta
Antihypertensive Agents - therapeutic use
Antihypertensives
Blood pressure
cardiology
Cardiovascular Diseases - drug therapy
Cardiovascular Medicine
clinical pharmacology
clinical trials
Collaboration
Consent
Glaucoma
Glaucoma - chemically induced
Humans
Hypertension
Morbidity
Mortality
Patients
Pragmatic Clinical Trials as Topic
Primary care
Prospective Studies
Provinces
Randomized Controlled Trials as Topic
Research Design
Risk Factors
Sleep
Social networks
Treatment Outcome
Alberta
clinical pharmacology
primary care
clinical trials
hypertension
cardiology
Online AccessGet full text
ISSN2044-6055
2044-6055
DOI10.1136/bmjopen-2021-059711

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Abstract IntroductionSleep-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 analysisDesignProspective randomised, open-label, blinded end-point trial.ParticipantsHypertensive primary care patients using blood pressure lowering medication and free from glaucoma.SettingCommunity 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.InterventionConsenting 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 outcomeComposite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure.Secondary outcomesEach 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 outcomesSelf-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 analysisCox proportional hazards survival analysis.Sample sizeThe trial will continue until a projected 254 primary outcome events have occurred.Current statusEnrolment ongoing (3227 randomised to date).Ethics and disseminationBedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal.Trial registration numberNCT02990663.
AbstractList 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: Prospective randomised, open-label, blinded end-point trial. Hypertensive primary care patients using blood pressure lowering medication and free from glaucoma. 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. Consenting participants are allocated via central randomisation to bedtime vs morning use of all antihypertensives. (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. Composite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure. 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). 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). Cox proportional hazards survival analysis. The trial will continue until a projected 254 primary outcome events have occurred. Enrolment ongoing (3227 randomised to date). BedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal. NCT02990663.
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: DesignProspective randomised, open-label, blinded end-point trial.ParticipantsHypertensive primary care patients using blood pressure lowering medication and free from glaucoma.SettingCommunity 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.InterventionConsenting 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 outcomeComposite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure.Secondary outcomesEach 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 outcomesSelf-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 analysisCox proportional hazards survival analysis.Sample sizeThe trial will continue until a projected 254 primary outcome events have occurred.Current statusEnrolment ongoing (3227 randomised to date).INTRODUCTIONSleep-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: DesignProspective randomised, open-label, blinded end-point trial.ParticipantsHypertensive primary care patients using blood pressure lowering medication and free from glaucoma.SettingCommunity 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.InterventionConsenting 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 outcomeComposite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure.Secondary outcomesEach 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 outcomesSelf-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 analysisCox proportional hazards survival analysis.Sample sizeThe trial will continue until a projected 254 primary outcome events have occurred.Current statusEnrolment ongoing (3227 randomised to date).BedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal.ETHICS AND DISSEMINATIONBedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal.NCT02990663.TRIAL REGISTRATION NUMBERNCT02990663.
IntroductionSleep-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 analysisDesignProspective randomised, open-label, blinded end-point trial.ParticipantsHypertensive primary care patients using blood pressure lowering medication and free from glaucoma.SettingCommunity 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.InterventionConsenting 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 outcomeComposite of all-cause death, or hospitalisation for myocardial infarction/acute-coronary syndrome, stroke or congestive heart failure.Secondary outcomesEach 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 outcomesSelf-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 analysisCox proportional hazards survival analysis.Sample sizeThe trial will continue until a projected 254 primary outcome events have occurred.Current statusEnrolment ongoing (3227 randomised to date).Ethics and disseminationBedMed has ethics approval from six research ethics review boards and will publish results in a peer-reviewed journal.Trial registration numberNCT02990663.
Author McAlister, Finlay A
Green, Lee
Kolber, Michael R
Mangin, Dee
Korownyk, Tina
McGrail, Kimberlyn
Manca, Donna P
Wong, Sabrina T
Padwal, Raj S
Hill, Michael D
Singer, Alexander
O'Neill, Braden
Greiver, Michelle
Kirkwood, Jessica EM
Bakal, Jeffrey
McCracken, Rita
Garrison, Scott R
Manns, Braden
Froentjes, Liesbeth S
MacLean, Cathy
McCormack, James P
Trueman, Darryl R
Norris, Colleen
Allan, G Michael
AuthorAffiliation 12 Family Medicine , Providence Health Care , Vancouver , British Columbia , Canada
4 BedMed Patient Working Group , Edmonton , Alberta , Canada
14 Faculty of Pharmaceutical Science , University of British Columbia , Vancouver , British Columbia , Canada
2 Provincial Research Data Services , Alberta Health Services , Edmonton , Alberta , Canada
8 Centre for Health Services and Policy Research , University of British Columbia , Vancouver , British Columbia , Canada
9 Family and Community Medicine , University of Toronto , Toronto , Ontario , Canada
1 Family Medicine , University of Alberta , Edmonton , Alberta , Canada
11 Academic Family Medicine , University of Saskatchewan , Saskatoon , Saskatchewan , Canada
13 Family Practice , University of British Columbia Faculty of Medicine , Vancouver , British Columbia , Canada
15 Faculty of Nursing , University of Alberta , Edmonton , Alberta , Canada
6 Clinical Neurosciences , University of Calgary , Calgary , Alberta , Canada
5 Medicine , University of
AuthorAffiliation_xml – name: 13 Family Practice , University of British Columbia Faculty of Medicine , Vancouver , British Columbia , Canada
– name: 11 Academic Family Medicine , University of Saskatchewan , Saskatoon , Saskatchewan , Canada
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– name: 9 Family and Community Medicine , University of Toronto , Toronto , Ontario , Canada
– name: 4 BedMed Patient Working Group , Edmonton , Alberta , Canada
– name: 8 Centre for Health Services and Policy Research , University of British Columbia , Vancouver , British Columbia , Canada
– name: 6 Clinical Neurosciences , University of Calgary , Calgary , Alberta , Canada
– name: 7 Nephrology , University of Calgary , Calgary , Alberta , Canada
– name: 2 Provincial Research Data Services , Alberta Health Services , Edmonton , Alberta , Canada
– name: 3 Family Medicine , University of Manitoba College of Medicine , Winnipeg , Manitoba , Canada
– name: 10 Family Medicine , McMaster University , Hamilton , Ontario , Canada
– name: 12 Family Medicine , Providence Health Care , Vancouver , British Columbia , Canada
– name: 15 Faculty of Nursing , University of Alberta , Edmonton , Alberta , Canada
– name: 1 Family Medicine , University of Alberta , Edmonton , Alberta , Canada
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  surname: Allan
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/35210352$$D View this record in MEDLINE/PubMed
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– notice: 2022 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. http://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/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
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Keywords clinical pharmacology
primary care
clinical trials
hypertension
cardiology
Language English
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Snippet IntroductionSleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates...
Sleep-time blood pressure correlates more strongly with adverse cardiovascular events than does daytime blood pressure. The BedMed trial evaluates whether...
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SubjectTerms Alberta
Antihypertensive Agents - therapeutic use
Antihypertensives
Blood pressure
cardiology
Cardiovascular Diseases - drug therapy
Cardiovascular Medicine
clinical pharmacology
clinical trials
Collaboration
Consent
Glaucoma
Glaucoma - chemically induced
Humans
Hypertension
Morbidity
Mortality
Patients
Pragmatic Clinical Trials as Topic
Primary care
Prospective Studies
Provinces
Randomized Controlled Trials as Topic
Research Design
Risk Factors
Sleep
Social networks
Treatment Outcome
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Title Bedtime versus morning use of antihypertensives for cardiovascular risk reduction (BedMed): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial
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https://www.ncbi.nlm.nih.gov/pubmed/35210352
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Volume 12
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