HypertensionOptimizeBPNCT05047731
Antihypertensive Deprescribing in Long-term Care
A study testing Antihypertensive medication in people with Hypertension and Frailty, run by University of Alberta at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hypertension, Frailty
- What is being tested?
- Antihypertensive medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2021to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥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.
Who cannot join
- ≥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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Frailty
- Being tested
- Antihypertensive medication
- Keywords
- Pragmatic trial, Long-term care, Nursing home, Hypertension, Antihypertensive agents, Deprescriptions, Routinely collected health data, Frail older adult
- Medical subject headings
- Hypertension, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihypertensive medicationDrug
Antihypertensive medication will be continually reduced provided an upper systolic threshold of 145 mmHg is not exceeded
| Study group | Role | What they receive |
|---|---|---|
| Deprescribing group | Experimental | The facility pharmacist will actively deprescribe antihypertensive medication of residents in this group. Receives: Drug: Antihypertensive medication |
| Usual care group | No intervention | The facility pharmacist and the attending physician will provide usual care to residents in this group, and this includes quarterly medication reviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
All-cause death - as recorded in government health claim databases
Measured: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Secondary outcomes (1)
Composite of All-Cause Mortality or All-Cause Unplanned Hospitalization
Composite of all-cause death and unplanned hospital admission or emergency room visit - as recorded in government health claim databases
Measured: through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start20 Sep 2021
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Roni Kraut, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047731
- Sponsor's protocol ID
- Pro00097312
- Acronym
- OptimizeBP
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kraut RY, Youngson E, Sadowski CA, Bakal JA, Faulder D, Korownyk CS, Vucenovic A, Eurich DT, Manca DP, Lundby C, Kivi P, Manville M, Garrison SR. Antihypertensive deprescribing in frail long-term care residents (OptimizeBP): protocol for a prospective, randomised, open-label pragmatic trial. BMJ Open. 2024 Aug 29;14(8):e084619. doi: 10.1136/bmjopen-2024-084619.
PubMed 39209778
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive Deprescribing in Long-term Care: A Randomized Controlled Trial (OptimizeBP)
- ClinicalTrials.gov ID
- NCT05047731
- Acronym / sponsor ID
- OptimizeBP / Pro00097312
- Conditions
- Hypertension, Frailty
- Keywords
- Pragmatic trial, Long-term care, Nursing home, Hypertension, Antihypertensive agents, Deprescriptions, Routinely collected health data, Frail older adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deprescribing group | Experimental | Drug: Antihypertensive medicationThe facility pharmacist will actively deprescribe antihypertensive medication of residents in this group. |
| Usual care group | No intervention | –The facility pharmacist and the attending physician will provide usual care to residents in this group, and this includes quarterly medication reviews. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ≥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.
Key exclusion criteria (5 listed)
- ≥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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihypertensive medicationAntihypertensive medication will be continually reduced provided an upper systolic threshold of 145 mmHg is not exceeded | Drug | Deprescribing group |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Results publication: PubMed 39209778Kraut RY, Youngson E, Sadowski CA, Bakal JA, Faulder D, Korownyk CS, Vucenovic A, Eurich DT, Manca DP, Lundby C, Kivi P, Manville M, Garrison SR. Antihypertensive deprescribing in frail long-term care residents (OptimizeBP): protocol for a prospective, randomised, open-label pragmatic trial. BMJ Open. 2024 Aug 29;14(8):e084619. doi: 10.1136/bmjopen-2024-084619.
- OptimizeBP protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roni Kraut principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antihypertensive medication in people with Hypertension and Frailty, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.