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Bedtime Blood Pressure Pills for High Blood Pressure

N/A

Waitlist Available

Led By Scott R Garrison, MD, PhD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hypertension diagnosis as indicated by ≥ 2 billing diagnoses at any time in the administrative claims data by any provider

Prescribed with ≥ 1 once daily BP lowering medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years (estimate only - study continues until 368 participants have experienced primary outcome events)

Awards & highlights

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%.

Who is the study for?

This trial is for elderly residents in nursing homes with high blood pressure, who are taking medication once daily. They must have had at least two hypertension diagnoses. Those with a history of glaucoma or on glaucoma meds, and anyone (patient/family/doctor) opting out aren't eligible.Check my eligibility

What is being tested?

The study tests if taking blood pressure pills at bedtime instead of morning can better prevent heart attacks and strokes without causing harm like falls or fractures. Residents will be randomly assigned to continue morning intake or switch to bedtime intake.See study design

What are the potential side effects?

Potential side effects may include increased risk of falls and fractures due to lower overnight blood pressure. The impact on other conditions such as dementia will also be observed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high blood pressure at least twice.

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I am taking medication daily to lower my blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years (estimate only - study continues until 368 participants have experienced primary outcome events)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years (estimate only - study continues until 368 participants have experienced primary outcome events)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years (estimate only - study continues until 368 participants have experienced primary outcome events) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of Major Adverse Cardiovascular Events

Secondary outcome measures

Acute Care Costs

All Cause Mortality

All Cause Unplanned Hospitalization

+9 more

Other outcome measures

Number of Participants Indicated by Nursing to Have at Least One "Indicator of Depression or Anxiety" Almost Daily in the 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 or Physical Restraints

+4 more

Trial Design

2Treatment groups

Active Control

Group I: Bedtime Antihypertensive MedicationsActive Control1 Intervention

The LTC facility's pharmacist will switch all once daily antihypertensive medications, one at a time as tolerated, to bedtime. Blood pressure lowering medications taken more than once per day are left alone.

Group II: Morning Antihypertensive MedicationsActive Control1 Intervention

No change to blood pressure medication timing is made. By default, most patients are using once daily antihypertensive medications in the morning at baseline.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

383,903 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,340 Previous Clinical Trials

26,451,823 Total Patients Enrolled

EnACtUNKNOWN

Media Library

Bedtime administration of antihypertensive medications (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04054648 — N/A

High Blood Pressure Research Study Groups: Bedtime Antihypertensive Medications, Morning Antihypertensive Medications

High Blood Pressure Clinical Trial 2023: Bedtime administration of antihypertensive medications Highlights & Side Effects. Trial Name: NCT04054648 — N/A

Bedtime administration of antihypertensive medications (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054648 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open positions available for this experiment?

"Clinicaltrials.gov reveals that this research project is not presently enrolling participants, as the first post was made on 14th May 2020 and last edited on 22nd February 2022. Nevertheless, there are still 1145 clinical trials actively recruiting patients across multiple locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BedMed-Frail: Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations?

Scott Garrison 2020. "BedMed-Frail: Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054648.