What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors and ARBs, which can cause side effects like cough, elevated blood potassium levels, and kidney dysfunction. Calcium channel blockers may lead to swelling in the lower extremities, constipation, and dizziness. Thiazide diuretics can result in electrolyte imbalances, such as low potassium and sodium levels, and increased uric acid levels, potentially leading to gout. Beta-blockers are associated with fatigue, cold extremities, and may exacerbate asthma or other respiratory conditions. These side effects are important to consider, especially in frail older adults, as they may increase the risk of falls, cognitive impairment, and other adverse outcomes.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including ACE inhibitors (e.g., enalapril, lisinopril), angiotensin receptor blockers (ARBs) (e.g., losartan, valsartan), calcium channel blockers (e.g., amlodipine), and thiazide diuretics. These medications are commonly used to manage hypertension but may be deprescribed in frail older adults to avoid unnecessarily low systolic blood pressure, as overly aggressive treatment can lead to adverse effects such as falls and cognitive impairment.

What other types of research exist?

Promising novel alternatives to blood pressure medication deprescribing for high blood pressure patients include: 1) Firibastat, a first-in-class brain aminopeptidase A inhibitor, which has shown potential in clinical trials for managing hypertension. 2) Intensive blood pressure lowering strategies, which have been associated with reduced cardiovascular morbidity in high-risk patients. 3) Non-pharmacological interventions such as comprehensive lifestyle modifications, including diet, weight loss, and physical fitness programs, which have demonstrated efficacy in controlling blood pressure.

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Antihypertensive

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

N/A

Waitlist Available

Led By Roni Kraut

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

≥2 diagnoses (dx) of hypertension from either a community practitioner or/and from a hospital admission

on ≥1 oral antihypertensive medication

Must not have

the resident's only antihypertensive prescribed in the last 15 days is an alpha blocker

≥2 community dx of tachycardia/atrial fibrillation or ≥1 dx of in hospital tachycardia/atrial fibrillation and the only antihypertensive prescribed in the last 15 days is a beta blocker and/or a calcium channel blocker

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from adjusting antihypertensive medications may include changes in blood pressure that could affect the risk of falls or cognitive impairment, as well as possible impacts on hospitalization rates and quality of life.

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 at least one pill for high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

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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I have been diagnosed with coronary artery disease and am only on beta blockers or calcium channel blockers.

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My only blood pressure medicine in the last 15 days is a beta blocker.

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I or my legal guardian do not consent to participate in the study.

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I have been diagnosed with congestive heart failure multiple times or have been prescribed furosemide recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event)

This trial's timeline: 3 weeks for screening, Varies for treatment, and ≥6-weeks post-randomisation through study completion (estimated to be 4 years, trial will continue until 247 participants have experienced the primary outcome event) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All-Cause Mortality

Secondary study objectives

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

Other study objectives

Acute Care Costs

All-Cause Unplanned Hospitalization

Average Systolic Blood Pressure and Average Diastolic Blood Pressure

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include diuretics, ACE inhibitors, ARBs, beta-blockers, and calcium channel blockers. Diuretics help the kidneys remove excess sodium and water, reducing blood volume. ACE inhibitors and ARBs relax blood vessels by inhibiting the renin-angiotensin-aldosterone system, which decreases blood pressure. Beta-blockers reduce heart rate and the force of contraction, lowering blood pressure. Calcium channel blockers prevent calcium from entering heart and blood vessel cells, leading to relaxed vessels. Understanding these mechanisms is crucial for high blood pressure patients, as it helps in tailoring treatment to avoid excessively low blood pressure, which can lead to adverse effects like falls and cognitive impairment, especially in frail older adults.

[120 mmHg for everyone?].Prehypertension: the rationale for early drug therapy.Recent hypertension trials: implications and controversies.