What side effects are associated with this type of intervention?

Common treatments for high blood pressure include ACE inhibitors, ARBs, calcium channel blockers, thiazide diuretics, and beta-blockers. ACE inhibitors can cause a persistent dry cough, elevated blood potassium levels, and, rarely, angioedema. ARBs may lead to dizziness, elevated blood potassium levels, and, less commonly, kidney dysfunction. Calcium channel blockers often cause swelling in the lower extremities, dizziness, and constipation. Thiazide diuretics can result in electrolyte imbalances, increased urination, and, occasionally, gout. Beta-blockers may cause fatigue, cold extremities, and, in some cases, depression or erectile dysfunction. These side effects should be discussed with a healthcare provider to ensure the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several classes of antihypertensive medications for the treatment of high blood pressure, which are often used in home blood pressure monitoring programs to ensure adherence and effectiveness. These include Angiotensin-Converting Enzyme (ACE) inhibitors such as enalapril and lisinopril, Angiotensin II Receptor Blockers (ARBs) like valsartan, calcium channel blockers such as amlodipine, and thiazide-like diuretics like hydrochlorothiazide. These medications have been shown to be effective in lowering blood pressure and are commonly prescribed in combination to achieve better control, especially in home-based monitoring settings.

What other types of research exist?

Promising novel alternatives to Supported Home Blood Pressure Monitoring (HBPM) for high blood pressure patients in 2024 include: 1) Telehealth platforms with application-based blood pressure management, which provide remote monitoring and personalized feedback. 2) Remote monitoring technologies that use wearable devices to continuously track blood pressure and other vital signs. 3) Integration of behavioral economics in remote monitoring to improve patient adherence and outcomes. 4) Advanced pharmacological treatments, such as fixed-dose combination therapies and novel antihypertensive agents, which offer improved efficacy and patient compliance.

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Supported HBPM Program for High Blood Pressure (MonitorBP Trial)

N/A

Recruiting

Led By Ian Kronish, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

Age 18-85 years old

Hypertension (as per International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes)

Must not have

Medical director declines participation in the trial

Stage 5 or end-stage kidney disease (as per ICD-10 codes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Summary

This trial aims to see if a supported home blood pressure monitoring program can help patients with uncontrolled hypertension manage their condition better. The program provides tools and support for patients to measure their blood pressure at home and share the results with their doctors. The goal is to improve blood pressure control by making it easier for doctors to monitor and adjust treatments. Home blood pressure monitoring is a self-monitoring tool recommended by major guidelines and supported by evidence for its benefits in improving blood pressure control.

Who is the study for?

This trial is for adults aged 18-85 with high blood pressure who are patients at certain New York medical practices, including those specializing in HIV medicine. They must have had a primary care visit within a specific timeframe and cannot participate if they have advanced dementia, frailty, pregnancy, stage 5 kidney disease, terminal illness or if their medical director opts out.

What is being tested?

The study is testing whether a supported home blood pressure monitoring (HBPM) program combined with an implementation strategy can improve its adoption across diverse patient populations in multiple practices compared to usual care without the HBPM program.

What are the potential side effects?

Since this trial involves implementing a home monitoring program rather than medication or invasive procedures, there are no direct side effects associated with the interventions being studied.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 85 years old.

Select...

I have been diagnosed with high blood pressure.

Exclusion Criteria

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

Select...

My doctor has advised against joining this trial.

Select...

My condition is end-stage kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Change in patient's office systolic blood pressure (SBP)

Secondary study objectives

Antihypertensive medication adherence

Change in patient's antihypertensive medication regimen intensity

Office diastolic blood pressure (DBP)

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Intervention Clinics, Pre-Implementation PeriodExperimental Treatment1 Intervention

Usual care

Group II: Intervention Clinics, Post-Implementation PeriodExperimental Treatment1 Intervention

Access to Supported HBPM program plus a multifaceted implementation strategy designed to increase uptake of the program by primary care patients with uncontrolled hypertension

Group III: Control Clinics, Pre-Implementation PeriodExperimental Treatment1 Intervention

Usual care

Group IV: Control Clinics, Post-Implementation PeriodExperimental Treatment1 Intervention

Usual care

0 / 4Eligibility 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

Thiazide diuretics help reduce blood pressure by promoting the excretion of sodium and water through the kidneys, which decreases blood volume. ACE inhibitors and ARBs work by inhibiting the renin-angiotensin-aldosterone system, leading to vasodilation and reduced blood volume. Calcium channel blockers prevent calcium from entering the cells of the heart and blood vessel walls, resulting in lower blood pressure through vasodilation. These mechanisms are crucial for high blood pressure patients as they directly target the physiological pathways that elevate blood pressure, making them effective in reducing the risk of cardiovascular events. Home Blood Pressure Monitoring (HBPM) ensures adherence and effectiveness of these treatments by providing regular feedback and enabling timely adjustments.

2020 Consensus summary on the management of hypertension in Asia from the HOPE Asia Network.