Bedtime Antihypertensive Medications for Hypertension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hypertension+1 More
Bedtime administration of the participant's pre-existing antihypertensive medications - Other
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at whether giving blood pressure pills at bedtime, instead of in the morning, reduces death, heart attack, and stroke by more than 50%.

Eligible Conditions
  • Hypertension
  • Dementia

Treatment Effectiveness

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 2 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)

Year 2
Acute Care Costs
All Cause Mortality
All Cause hospitalization
Composite of Major Adverse Cardiovascular Events
Fracture
Hospitalization for Acute Coronary Syndrome / Myocardial Infarction
Hospitalization for Congestive Heart Failure
Cerebrovascular accident
Month 6
Number of Days per Week (last 7 days) Anti-Anxiety Medication is Used Among Those Who Use it Less Than Daily (i.e. among those who use it as needed, and not regularly)
Number of Days per Week (last 7 days) Hypnotic (Bedtime Sleeping Pill) Medication is Used Among Those Who Use it Less Than Daily (i.e. among those who use it as needed, and not regularly)
Number of Participants Indicated by Nursing to have "Indicators of Depression or Anxiety Almost Daily in last 30 days"
Number of Participants with "Behavioural Symptoms that are Present a Minimum of 4 Days per Week and Not Easily Altered" Including a) Wandering, b) Verbal Abuse, c) Physical Abuse, d) Socially Inappropriate or Disruptive Behaviour, or e) Resisting Care
Number of Participants with Receipt (last 7 days) of Antipsychotic Medication
Number of Participants with Receipt (last 7 days) of Antipsychotic Medication or Physical Restraints
Number of Participants with Receipt (last 7 days) of Physical Restraints
Number of Patients with "Deteriorated Cognition Relative to Status 90 Days Prior"
Number of Patients with Full Thickness Skin Ulceration (Stage 3 or 4)
Number of Patients with Urinary Continence
Number of Patients with a Fall in the Last 30 days
6 months
Number of Blood Pressure Medications Used More than Once Daily 6 Months Post Randomization (Process Outcome)
Number of Once Daily Blood Pressure Medications in Use 6 Months Post Randomization (Process Outcome)
Percentage of Once Daily Blood Pressure Medications Taken According to Allocation (Process Outcome)

Trial Safety

Trial Design

2 Treatment Groups

Bedtime Antihypertensive Medications
1 of 2
Morning Antihypertensive Medications
1 of 2

Active Control

775 Total Participants · 2 Treatment Groups

Primary Treatment: Bedtime Antihypertensive Medications · No Placebo Group · N/A

Bedtime Antihypertensive Medications
Other
ActiveComparator Group · 1 Intervention: Bedtime administration of the participant's pre-existing antihypertensive medications · Intervention Types: Other
Morning Antihypertensive MedicationsNoIntervention Group · 1 Intervention: Morning Antihypertensive Medications · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years (estimate only - study continues until 368 participants have experienced primary outcome events)

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,221 Previous Clinical Trials
24,402,361 Total Patients Enrolled
42 Trials studying Hypertension
2,970,069 Patients Enrolled for Hypertension
University of AlbertaLead Sponsor
806 Previous Clinical Trials
368,918 Total Patients Enrolled
15 Trials studying Hypertension
7,112 Patients Enrolled for Hypertension
EnACtUNKNOWN
Alberta Health servicesOTHER
143 Previous Clinical Trials
304,759 Total Patients Enrolled
4 Trials studying Hypertension
6,290 Patients Enrolled for Hypertension
Alberta Innovates Health SolutionsOTHER
49 Previous Clinical Trials
104,077 Total Patients Enrolled
4 Trials studying Hypertension
9,841 Patients Enrolled for Hypertension
Danielle Perry, BScN, RNStudy DirectorUniversity of Alberta
Scott R Garrison, MD, PhDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
3,357 Total Patients Enrolled
1 Trials studying Hypertension
3,357 Patients Enrolled for Hypertension

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A physician must have diagnosed hypertension in at least 2 billing diagnoses at any time in the administrative claims data.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.