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The Effect of Antihypertensive Medication Timing on Morbidity and Mortality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990663
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : June 16, 2022
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Alberta Health services
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
High blood pressure is common and its presence increases the risk of cardiovascular mortality and morbidity (most notably stroke, myocardial infarction, and congestive heart failure). Given blood pressure is normally higher during the day than it is overnight, blood pressure lowering medications are traditionally taken in the morning. However a randomized trial of 2156 Spanish hypertension patients published in 2010 ("MAPEC"), suggests a large (61%) reduction in mortality and cardiovascular morbidity if such medications are instead taken at bedtime. This degree of benefit far exceeds other established methods of cardiovascular risk reduction - and such a surprisingly large effect requires independent confirmation for practice to change. BedMed is a pragmatic randomized controlled trial facilitated by over 400 Canadian family physician members of the Pragmatic Trials Collaborative. During the conduct of this trial consenting hypertensive primary care patients, already established on one or more antihypertensive medications, will be randomized to either morning or bedtime antihypertensive use. Patient oriented trial outcomes evaluating both potential benefits and harms will be drawn largely from administrative health data that is routinely collected on all residents of Canada's publicly funded health care system. This trial is being conducted in 5 Canadian provinces and will continue to collect data until late 2023, at which point 254 primary outcome events are anticipated.

Condition or disease Intervention/treatment Phase
Hypertension Other: Use of blood pressure lowering medication at bedtime Other: Use of blood pressure lowering medication in the morning Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Antihypertensive Medication Timing on Morbidity and Mortality: The "BedMed" RCT
Study Start Date : December 2016
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bedtime BP Meds
Use of blood pressure lowering medication at bedtime
Other: Use of blood pressure lowering medication at bedtime
Blood pressure lowering medications will be switched (one at a time as tolerated) to bedtime, or maintained at bedtime if already taken at that time. All decisions related to which, and how many, medications to switch are at the discretion of the care provider.

Active Comparator: Morning BP Meds
Use of blood pressure lowering medication in the morning
Other: Use of blood pressure lowering medication in the morning
Blood pressure lowering medications will be switched (one at a time as tolerated) to morning, or maintained in the morning if already taken at that time. All decisions related to which, and how many, medications to switch are at the discretion of the care provider.




Primary Outcome Measures :
  1. Major Adverse Cardiovascular Events [ Time Frame: Through study completion, an average of 4 years ]
    First occurrence of either death (all-cause), or hospitalization or emergency department visit for acute coronary syndrome / MI, congestive heart failure, or stroke.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Through study completion, an average of 4 years ]
    Death from any cause.

  2. Acute coronary syndrome [ Time Frame: Through study completion, an average of 4 years ]
    Hospitalization or ER visit for acute coronary syndrome or MI.

  3. CHF Hospitalization [ Time Frame: Through study completion, an average of 4 years ]
    Hospitalization or ER visit for congestive heart failure.

  4. Stoke [ Time Frame: Through study completion, an average of 4 years ]
    Hospitalization or ER visit for stroke (excludes TIA).

  5. All-cause hospitalization [ Time Frame: Through study completion, an average of 4 years ]
    Hospitalization or ER visit for any cause

  6. Long term care admission [ Time Frame: Through study completion, an average of 4 years ]
    Newly admitted to a nursing home or assisted living facility as primary residence

  7. New glaucoma diagnosis [ Time Frame: Through study completion, an average of 4 years ]
    First-ever glaucoma diagnosis

  8. Non-vertebral fracture [ Time Frame: Through study completion, an average of 4 years ]
    Fracture of any bone other than the vertebra of the back or neck

  9. Cognitive decline [ Time Frame: 18 months ]
    Cognitive performance worsening by 2 or more points compared to baseline, as measured by the Short Blessed Test


Other Outcome Measures:
  1. Acute care costs [ Time Frame: Through study completion, an average of 4 years ]
    Acute care costs (derived from each admission's resource intensity weight and length of stay)

  2. Total cost of care [ Time Frame: Through study completion, an average of 4 years ]
    Acute care costs + medication costs + physician billings

  3. Self-reported Overall Health Score [ Time Frame: 1 year ]
    As measured by the EQ-5D-5L

  4. Light-headedness [ Time Frame: Through study completion, an average of 4 years ]
    Self-reported light-headedness or feeling "faint" without loss or consciousness in the prior month - yes / no. (Asked at 6-weeks, 6 months, and every 6 months)

  5. Syncope [ Time Frame: Through study completion, an average of 4 years ]
    Self-reported fainting (loss of consciousness) in the prior month - yes / no. (Asked at 6-weeks, 6 months, and every 6 months)

  6. Falling [ Time Frame: Through study completion, an average of 4 years ]
    Self-reported falling in the prior month - yes / no. (Asked at 6-weeks, 6 months, and every 6 months)

  7. Nocturnal and daytime blood pressure [ Time Frame: 6 months ]
    302 subjects will undergo 24-hour BP monitoring after 6 months to determine differences in blood pressure between groups.

  8. Self-reported worsening of vision [ Time Frame: Through study completion, an average of 4 years ]
    Vision self-reported as "much worse" compared to the last follow-up at any point, or "slightly worse" than the last follow-up, on 2 or more occasions (Note: vision is reported at 6-weeks, 6-months, and every 6-months, as either "unchanged", "slightly worse", or "much worse" than the last follow-up)

  9. New impairment consistent with dementia [ Time Frame: Through study completion, an average of 4 years ]
    Short Blessed Test score newly 10 or greater at 18-month assessment, or new physician administrative claims diagnosis of dementia at any point during follow-up

  10. Hip fracture [ Time Frame: Through study completion, an average of 4 years ]
    Any break of the hip joint or femoral neck

  11. Nocturia frequency [ Time Frame: 6-months ]
    Self-reported change from baseline in the number of overnight urinations per week (at 6-weeks and 6-months)

  12. Nocturia burden [ Time Frame: 6-months ]
    Self-reported nocturia burden in the prior month, recorded as no nocturia, or nocturia that is "no problem", "minor problem", or "major problem" (at 6-weeks and 6-months)

  13. Adherence to medication timing allocation [ Time Frame: 6-months ]
    Proportion of BP medication doses taken at the allocated time at 6-months (twice daily medications being considered as ½ dose in the AM and ½ dose in the PM for this calculation)



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hypertension diagnosis as assigned by a physician or nurse practitioner
  2. ≥ 1 blood pressure medication taken once daily, or primary care provider willing to convert ≥ 1 blood pressure medication to once daily
  3. Community dwelling (i.e. not residing in a nursing home; assisted living permitted)

Exclusion Criteria:

  1. Palliative (as per primary care provider's judgement)
  2. Unable to provide informed consent (as per primary care provider's judgement)
  3. Personal history of glaucoma or use of glaucoma medications
  4. Sleep disrupting shift work (more than 3 shifts/month during participant's regular sleeping hours)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990663


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2T4
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Alberta Health services
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Scott R Garrison, MD, PhD University of Alberta
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02990663    
Other Study ID Numbers: BedMed Nov 30 2016
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon completion of all planned studies related to this project, anonymized patient level data for all outcomes and baseline characteristics will be made available in the form of a downloadable spreadsheet accessed through the Pragmatic Trials Collaborative's website (www.PragmaticTrials.ca)
Keywords provided by University of Alberta:
Pragmatic
Primary Care
Chronotherapy
Administrative Data
Stroke
Myocardial Infarction
Congestive Heart Failure
Glaucoma
Dementia
Hip Fracture
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases