What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, beta-blockers, calcium channel blockers, diuretics, and angiotensin II receptor blockers (ARBs). ACE inhibitors can cause a persistent dry cough and elevated blood potassium levels. Beta-blockers may lead to fatigue, cold hands and feet, and slow heart rate. Calcium channel blockers can cause swelling in the lower extremities, dizziness, and constipation. Diuretics may result in increased urination, electrolyte imbalances, and dehydration. ARBs are generally well-tolerated but can occasionally cause dizziness and elevated blood potassium levels. These side effects should be discussed with a healthcare provider to ensure optimal management.

What prior FDA approvals exist?

The FDA has approved several classes of medications for the treatment of high blood pressure, including thiazide diuretics, ACE inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers (CCBs), and beta-blockers. These medications are often used in combination to achieve better blood pressure control. The OPTIMA-BP trial focuses on leveraging mHealth technologies to improve adherence to these medications, which is crucial for effective hypertension management. While the trial itself is centered on technology rather than specific drugs, the medications studied are those commonly approved and used in clinical practice for hypertension.

What other types of research exist?

Promising alternatives to OPTIMA-BP for high blood pressure patients in 2024 include device-based therapies like renal denervation and baroreceptor activation therapy, telemedicine approaches such as remote patient monitoring and teleconsultation, and new pharmacological treatments including novel antihypertensive medications and combination therapies.

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Technology Intervention for High Blood Pressure

N/A

Recruiting

Led By Carolyn Still, PhD

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

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

Must have

Prescribed at least two hypertensive, one of which is a diuretic/thiazide and or calcium channel blocker antihypertensive medication

50 years of age or older

Must not have

Patients with a diagnosis of chronic kidney disease (defined as estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2) and/or receiving dialysis.

Unable to give informed consent or judged to have impaired cognitive ability or severe memory

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a mobile health program called OPTIMA-BP that helps older African American adults manage their high blood pressure. The program uses smartphones and text messages to remind patients to take their medications and follow healthy habits. The goal is to improve blood pressure control and overall health in this high-risk group.

Who is the study for?

This trial is for African American individuals over 50 with high blood pressure (BP≥130/80 but <160/90 mmHg), taking at least two BP medications including a diuretic or calcium channel blocker, and who own a smartphone. It's not for those who've had major cardiovascular events in the past year, have cognitive impairments, use other medication apps, show high BP variability, or have severe kidney disease.

What is being tested?

The OPTIMA-BP trial tests an intervention using mobile health technologies to improve medication adherence and manage high blood pressure among older African Americans. The study aims to see if this tech-based support can help control BP better and reduce health disparities.

What are the potential side effects?

Since the intervention involves technology use rather than medications or invasive procedures, direct side effects are minimal. However, participants may experience challenges related to technology use such as privacy concerns or stress from learning new tools.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am taking two blood pressure medicines, including a water pill or calcium blocker.

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I am 50 years old or older.

Exclusion Criteria

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

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I have chronic kidney disease or am on dialysis.

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I am able to understand and consent to my treatment.

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I had a major heart event or surgery in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Blood Pressure Control

Health Related Quality of Life (HRQOL)

Secondary study objectives

Biological risk markers

Controlled BP (<130/80 mmHg)

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: Intervention: OPTIMA-BP ImplementationExperimental Treatment1 Intervention

Participants randomized to OPTIMA-BP intervention for 6 months then observed for a 6 month follow up period

Group II: Waitlist: OPTIMA-BP implementationActive Control1 Intervention

Participants randomized to waitlist for 6 months, then offered the OPTIMA-BP intervention for 6 months.

0 / 5Eligibility 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 ACE inhibitors, ARBs, beta-blockers, calcium channel blockers, and diuretics. ACE inhibitors and ARBs work by inhibiting the renin-angiotensin system, which reduces blood vessel constriction and decreases blood volume. 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 blood vessels. Diuretics help the kidneys remove excess sodium and water, reducing blood volume. These mechanisms are crucial for managing high blood pressure as they target different pathways to lower blood pressure effectively. The use of mHealth technologies, as studied in the OPTIMA-BP trial, can enhance medication adherence and BP control by providing patients with tools to monitor and manage their condition more effectively.