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The Effect of Antihypertensive Medication Timing on Morbidity and Mortality

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ClinicalTrials.gov Identifier: NCT02990663
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
Alberta Health Services
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 (target N = 8750) facilitated by over 300 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 event driven (ending upon the occurrence of 406 primary outcome events) and expected to run over a period of roughly 3 years.

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)
Estimated Enrollment : 8750 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 : February 2022
Estimated Study Completion Date : February 2022

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: This study is event driven with quarterly evaluation of total (both groups combined) primary outcome events. The primary analysis takes place upon the occurrence of 406 primary outcome events (anticipated to occur, on average, at 2.5 years follow-up). ]
    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: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Death from any cause.

  2. Acute coronary syndrome [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Hospitalization or ER visit for acute coronary syndrome or MI.

  3. CHF Hospitalization [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Hospitalization or ER visit for congestive heart failure.

  4. Stoke [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Hospitalization or ER visit for stroke (excludes TIA).

  5. All-cause hospitalization [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Hospitalization or ER visit for any cause

  6. Nursing home admission [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Admission to a nursing home facility as primary residence (excludes assisted living)

  7. Worsening of vision [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Self-reported worsening of vision compared to baseline - recorded as unchanged, slightly worse, or much worse. Excludes changes correctable by eyeglasses. (The investigators will also report new diagnosis of glaucoma and glaucoma surgery using administrative data at study conclusion)

  8. Hip fracture [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    As indicated by hip fracture surgery (The investigators will also report self-reported syncope / fainting and self-reported falls as the % of patients reporting one or more episodes in the previous month during each regularly scheduled telephone or e-mail follow-up)

  9. Cognitive decline [ Time Frame: 18 months ]
    Change from baseline in cognition as measured by the Short Blessed Test. (The investigators will also report % of patients in each arm with scores >= 7).

  10. Nocturia burden [ Time Frame: 6 weeks ]
    Self-reported nocturia burden in the prior month - recorded as no problem, minor problem, or major problem. (The investigators will also report change in number of overnight urinations at 6 weeks)


Other Outcome Measures:
  1. Acute care costs [ Time Frame: Upon observation of 406 primary outcome events - anticipated to occur at 2.5 years on average. ]
    Acute care costs (derived from each admission's resource intensity weight and length of stay)

  2. Change in self-reported Quality of Life [ Time Frame: 1 year ]
    As measured by the EQ-5D - including 5 functional health measures and the patient's self-reported overall health score

  3. Light-headedness [ Time Frame: 6 months ]
    Self-reported light-headedness or feeling "faint" without loss or consciousness in the prior month - yes / no. (The investigators will also report the proportion of patients with this, and other potential adverse effects, at each follow-up interview)

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



Information from the National Library of Medicine

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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 participating Primary Care Provider
  2. ≥ 1 Blood pressure medication (taken at any time of day)
  3. Community dwelling (includes assisted living)

Exclusion Criteria:

  1. Anticipated life expectancy < 2 years
  2. Unable to provide informed consent
  3. Personal history of glaucoma or use of glaucoma medications

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


Contacts
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Contact: Scott R Garrison, MD, PhD 780-248-1853 Scott.Garrison@UAlberta.ca
Contact: Nicole Olivier 780-492-1602 nolivier@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2T4
Contact: Scott R Garrison, MD, PhD    780-248-1853    Scott.Garrison@UAlberta.ca   
Contact: Nicole Olivier    780-492-1602    nolivier@ualberta.ca   
Principal Investigator: Scott Garrison, MD PhD         
Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Contact: Nicole Olivier    780-492-1602    nolivier@ualberta.ca   
Principal Investigator: Alexander Singer, MD         
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Alberta Health Services
Investigators
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Principal Investigator: Scott R Garrison, MD, PhD University of Alberta
Additional Information:
Publications:

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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: November 20, 2019
Last Verified: November 2019
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