Antihypertensive Deprescribing in Long-term Care (OptimizeBP)

January 6, 2026 updated by: University of Alberta

Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)

Frail older adults are commonly prescribed blood pressure medication, yet it is unclear if blood pressure medication is actually beneficial for them. Observational studies in this population suggest blood pressure medication has limited benefit and may even be harmful, including an increased risk for falls and cognitive impairment. Randomized controlled trials are needed to confirm this.

This study is a randomized controlled trial of blood pressure medication deprescribing, amongst long-term care residents with systolic blood pressure lower than 135 mmHg. In the intervention group, with physician consent, the facility pharmacist or nurse practitioner will continually reduce antihypertensives provided an upper systolic threshold of 145 mmHg is not exceeded. The control group will receive usual care. The hypothesis is that avoiding unnecessarily low systolic blood pressure is beneficial in a frail, end-of-life population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Observational evidence suggests antihypertensive medications have limited benefit and may even be harmful in the frail older adult population. Although more modest blood pressure targets are already recommended, the impact of deprescribing antihypertensive medication on mortality and morbidity in the frail older adult population has yet to be confirmed by randomized controlled trials.

The objective of this study is to determine, in hypertensive long-term care residents with a systolic blood pressure below 135 mmHg, whether "deprescribing" antihypertensive medications (provided an upper systolic threshold of 145 mmHg is not exceeded), compared to no change in prescribing, will delay all-cause mortality (our primary outcome).

The study is an event-driven 2-parallel group randomized controlled trial, to be conducted in participating Alberta long-term care (LTC) facilities. The trial operates under a waiver of consent, as the intervention is recommended care, with residents, physicians, and family having the ability to opt individual residents out of the study before eligibility is determined. Eligibility will be determined using linked administrative claims databases holding physician diagnoses and medication dispensed, and by using usual care systolic blood pressure collected by the LTC facility. The provincial data steward (Alberta Health Services) will access this data, determine eligibility, individually randomize eligible residents who have not opted out, and advise the facility pharmacist which patients are in the intervention group.

Facility pharmacists or nurse practitioners will then stop or reduce doses of antihypertensive medication in the intervention group according to a pre-defined deprescribing algorithm. The data steward will track outcomes using administrative claims data, and the study will end once 247 primary outcome events have been observed. This is anticipated to occur 3-years post the start of randomization. An interim data safety monitoring board, chaired by Dr. James M.Wright, hypertension specialist and Co-ordinating Editor of the Cochrane Hypertension Review Group, will convene upon observing 124 primary outcomes. This group will recommend whether or not the study should stop early based on observed efficacy, or safety concerns.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
522

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Multiple Locations, Alberta, Canada
        • Multiple long-term care facilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥2 diagnoses (dx) of hypertension from either a community practitioner or/and from a hospital admission.
  • On ≥1 oral antihypertensive medication (requires a dispensation in the preceeding 15 days).
  • Average recorded systolic BP of <135 mmHg.

Exclusion Criteria:

  • ≥2 community dx of congestive heart failure, ≥1 dx of in hospital congestive heart failure, ≥1 dx of emergency visit of congestive heart failure, dx of congestive heart failure in RAI-MDS 2.0, or prescription of furosemide in the last 15 days.
  • The resident's only antihypertensive prescribed is a beta blocker.
  • The resident's only antihypertensive prescribed is a calcium channel blocker and the resident has ≥1 health system encounters with a diagnosis of angina.
  • The resident's only antihypertensive prescribed is an alpha blocker.
  • Admitted to the hospital at the time of randomization; or opted out of the trial by the resident, their family, their physician, or the facility.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Deprescribing group
The facility pharmacist will actively deprescribe antihypertensive medication of residents in this group.
Drug: Antihypertensive medication
Antihypertensive medication will be continually reduced provided an upper systolic threshold of 145 mmHg is not exceeded
No Intervention: Usual care group
The facility pharmacist and the attending physician will provide usual care to residents in this group, and this includes quarterly medication reviews.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
All-cause death - as recorded in government health claim databases
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite of All-Cause Mortality or All-Cause Unplanned Hospitalization
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Composite of all-cause death and unplanned hospital admission or emergency room visit - as recorded in government health claim databases
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-Cause Unplanned Hospitalization
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
All cause hospitalization or emergency room visit excluding elective surgeries or booked procedures/planned follow-up care - as recorded in governmental health claims databases
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Non-Vertebral Fracture
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Any physician billing (hospital or community) for a fracture other than a vertebral fracture (which might indicate a vertebral compression fracture secondary to osteoporosis, and not trauma) - as recorded in government health claim databases
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Number of Participants with Record of ≥1 Fall in Last 30-days
Time Frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly Resident Assessment Instruction Minimum Data Set 2.0 (RAI-MDS 2.0) at the LTC facility in the 3- to 6-month window following randomization
4.5 Months (average - will occur within a 3- to 6-month post randomization window)
Number of Participants with Partial or Full Thickness Skin Ulceration (stage 2 to 4)
Time Frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
4.5 Months (average - will occur within a 3- to 6-month post randomization window)
Number of Participants with Renal Insufficiency
Time Frame: ≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Any eGFR <30 ml/min/1.73m2 ≥6-weeks post-randomisation as recorded in governmental health claim databases
≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Number of Participants with "Deteriorated Cognition as Compared to Status 90 Days Prior"
Time Frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 at the LTC facility in the 3- to 6-month window following randomization
4.5 Months (average - will occur within a 3- to 6-month post randomization window)
Number of Participants with "Deteriorated Mood as Compared to Status 90 Days Prior"
Time Frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
4.5 Months (average - will occur within a 3- to 6-month post randomization window)
Number of Participants with "Deteriorated Activities of Daily Living (ADL) as Compared to Status 90 Days Prior"
Time Frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
4.5 Months (average - will occur within a 3- to 6-month post randomization window)
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
Time Frame: 4.5 Months (average - will occur within a 3- to 6-month post randomization window)
As recorded in the first quarterly RAI-MDS 2.0 assessment at the LTC facility in the 3- to 6-month window following randomization
4.5 Months (average - will occur within a 3- to 6-month post randomization window)
Acute Care Costs
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Calculated from each hospital/emergency admission's resource intensity weight as recorded in government health claim databases
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Total Costs of Care
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Acute care costs + medication costs + physician billings + nursing/facility costs as recorded in governmental health claims data. Nursing/facility costs will be estimated from level of care and duration of stay.
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Number of Antihypertensive Medications with ≥25%, ≥50%, and 100% Reduction from Baseline in Dosage Dispensed
Time Frame: 3- and 6-months post-randomization
As recorded in government health claim databases
3- and 6-months post-randomization
Number of Participants with ≥1 Baseline Antihypertensive Medication with ≥25%, ≥50%, and 100% Reduction in Dosage Dispensed
Time Frame: 3- and 6-months post-randomization
As recorded in government health claim databases
3- and 6-months post-randomization
Number of Participants with the Addition of ≥1 New Antihypertensive Medication or Increase in Dosage from Baseline.
Time Frame: 3- and 6-months post-randomization
As recorded in government health claim databases
3- and 6-months post-randomization
Number of Discrete Antihypertensive Medications Used in the Last 15 days (baseline, 3- and 6-months post-randomisation)
Time Frame: 3- and 6-months post-randomization
As recorded in government health claim databases
3- and 6-months post-randomization
Number of Discrete Medications Used in the Last 15 Days (baseline, 3- and 6-months post-randomisation)
Time Frame: 3- to 6-months post-randomization
As recorded in government health claim databases
3- to 6-months post-randomization
Average Systolic Blood Pressure and Average Diastolic Blood Pressure
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
As recorded by the long-term care facility
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Unplanned All-Cause Hospitalization with a Diagnosis of Stroke, Heart Attack, Congestive Heart Failure or Atrial Fibrillation
Time Frame: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Unplanned hospital admission or emergency room visit for stroke, acute coronary syndrome/myocardial infarction, heart failure, or atrial fibrillation - as recorded in governmental health claims databases
through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alberta Health services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roni Kraut, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00097312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Although we hope to make a de-identified participant-level version of our final analytic dataset publicly available on our website (www.PragmaticTrials.ca), and will request to do so, this requires the permission of Alberta Health Services, who must weigh the privacy concerns.

IPD Sharing Time Frame

If approval from Alberta Health Services is obtained, data will be posted co-incident with the main results publication and intended for long-term availability.

IPD Sharing Access Criteria

The data will be downloadable in the form of an Excel spreadsheet for anyone who wishes to access it. No application process will be necessary.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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