Antihypertensive Deprescribing in Long-term Care

NCT05047731 | Completed DMC

• 1 other identifier: Pro00097312
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension; Frailty

Keywords

Pragmatic trial; Long-term care; Nursing home; Hypertension; Antihypertensive agents; Deprescriptions; Routinely collected health data; Frail older adult

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality

  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 Outcomes (1)

• Composite of All-Cause Mortality or All-Cause Unplanned Hospitalization

  through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

Other Outcomes (18)

• All-Cause Unplanned Hospitalization

  through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

• Non-Vertebral Fracture

  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

  4.5 Months (average - will occur within a 3- to 6-month post randomization window)

Study Arms (2)

Deprescribing group

EXPERIMENTAL

The facility pharmacist will actively deprescribe antihypertensive medication of residents in this group.

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.

Interventions

Antihypertensive medication DRUG

Antihypertensive medication will be continually reduced provided an upper systolic threshold of 145 mmHg is not exceeded

Deprescribing group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• ≥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.

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Multiple long-term care facilities

Multiple Locations, Alberta, Canada

Location

Related Publications (1)

• 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.

  PMID: 39209778 RESULT

Related Links

• OptimizeBP protocol

MeSH Terms

Conditions

Hypertension; Frailty

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roni Kraut

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: September 20, 2021
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

CA (1)