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450 Participants Needed

Reducing Blood Pressure Medication for High Blood Pressure in Frail Elderly
(OptimizeBP Trial)

Overseen ByRoni Kraut

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Antihypertensives

Must not be taking: Furosemide

Disqualifiers: Congestive heart failure, Angina, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial involves reducing blood pressure medication for some participants, but it doesn't specify if you must stop all current medications. If you're in the intervention group, your blood pressure medication may be gradually reduced with your doctor's consent.

What data supports the effectiveness of antihypertensive medication for reducing blood pressure in frail elderly patients?

Research shows that lowering blood pressure with antihypertensive medication can reduce the risk of heart-related problems and death in older adults. Although specific data for frail elderly patients is limited, studies suggest that even frail older adults can benefit from blood pressure reduction, as long as the treatment is well tolerated.¹ ² ³ ⁴ ⁵

Is reducing blood pressure medication safe for frail elderly people?

There is limited data on the safety of reducing blood pressure medication in frail elderly people, but available studies suggest that while caution is needed due to potential adverse events, intensive blood pressure lowering can be safe if well tolerated.¹ ³ ⁶ ⁷ ⁸

How is the antihypertensive drug treatment unique for frail elderly with high blood pressure?

This treatment is unique because it focuses on reducing blood pressure medication specifically for frail elderly patients, considering their frailty, multiple health issues, and potential risks of too low blood pressure, which are not typically addressed in standard hypertension treatments.³ ⁴ ⁵ ⁹ ¹⁰

What is the purpose of this trial?

This trial aims to see if reducing or stopping blood pressure medications in frail older adults with low blood pressure can improve their overall health and survival. The study will monitor various health outcomes to ensure safety and effectiveness.

Research Team

Roni Kraut

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for long-term care residents who are frail, have high blood pressure, and are on at least one oral antihypertensive medication with an average systolic BP below 135 mmHg. They must have been diagnosed with hypertension at least twice. Those on certain heart medications or with specific heart conditions cannot participate.

Inclusion Criteria

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

I am taking at least one pill for high blood pressure.

Your average blood pressure reading is less than 135 mmHg for the top number.

Exclusion Criteria

My doctor has decided not to participate in the study.

My only blood pressure medicine in the last 15 days is an alpha blocker.

I have been diagnosed with a fast heartbeat or atrial fibrillation and am only on beta blockers or calcium channel blockers.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Intervention

Eligible participants are randomized into either the deprescribing group or the usual care group. In the intervention group, antihypertensive medications are reduced according to a predefined algorithm.

3-6 months

Quarterly medication reviews

Follow-up

Participants are monitored for safety and effectiveness, including primary and secondary outcomes such as all-cause mortality and hospitalization.

4 years

Treatment Details

Interventions

Antihypertensive medication

Trial Overview The study tests if reducing blood pressure medication (deprescribing) in frail older adults leads to better health outcomes compared to usual care. The goal is to adjust their medication until their systolic blood pressure is around 140 mmHg, while monitoring mortality rates and other health factors.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Deprescribing groupExperimental Treatment1 Intervention

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

Group II: Usual care groupActive Control1 Intervention

The facility pharmacist and the attending physician will provide usual care to residents in this group, and this includes quarterly medication reviews.