Home BP Device Accuracy for High Blood Pressure

(VALID-HomeBP Trial)

Overseen By Remi Goupil, MD MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Disqualifiers: Atrial fibrillation, Aortic stenosis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the accuracy of various home blood pressure devices compared to a professional method known as awake ambulatory blood pressure monitoring (ABPM). It compares measurements from both validated devices, which have been checked for accuracy, and non-validated devices, which have not. Individuals with high blood pressure scheduled for an ABPM test may be suitable candidates for this trial. As an unphased study, this trial provides an opportunity to contribute to enhancing the accuracy of home blood pressure monitoring.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these home BP devices are safe for measuring blood pressure?

Research shows that validated home blood pressure (BP) devices are accurate. Testing has confirmed their correct readings, making them generally safe to use.

In contrast, non-validated BP devices lack such testing, so their accuracy is not guaranteed. The FDA warns that using these unapproved devices can be risky because they haven't been checked for safety and effectiveness.

This trial compares these different types of devices. However, only the validated ones currently have evidence supporting their safety and reliability in measuring BP. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to evaluate the accuracy of various home blood pressure (BP) monitors, which is crucial for managing high blood pressure effectively. Unlike traditional methods that rely on validated devices, this trial includes non-validated home BP devices to see how they stack up against validated ones. This could lead to better recommendations for at-home monitoring, ensuring patients get reliable readings without always needing a clinic visit. Ultimately, the goal is to empower patients with accurate tools for managing their condition in real-time.

What evidence suggests that these home BP devices are accurate for measuring high blood pressure?

This trial will compare the accuracy of different home blood pressure devices. Research has shown that home blood pressure monitors tested for accuracy are generally reliable. Studies confirm that these devices meet specific standards for measuring blood pressure correctly. The American Medical Association supports these standards to ensure dependable readings. Without testing, determining a device's accuracy is difficult. Tested devices are trusted because they have proven to work well. Participants in this trial will use either a validated home BP device or one of three non-validated home BP devices to measure blood pressure. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who are scheduled to undergo ambulatory blood pressure monitoring (ABPM). It's not specified who can't join, but typically those with conditions affecting BP measurement accuracy might be excluded.

Exclusion Criteria

Upper arm size outside of cuff range of selected devices (<22 cm or >42 cm)

Night shift workers

Contraindication to measure BP on the non-dominant arm

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Enrollment

Participants are enrolled and baseline blood pressure measurements are taken using both validated and non-validated home BP devices

1 day

1 visit (in-person)

Measurement

Blood pressure measurements are conducted using various home BP devices and compared to ambulatory blood pressure monitoring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any discrepancies in blood pressure measurements and device accuracy

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• awake ABPM

Trial Overview

The study is testing the accuracy of various home blood pressure devices sold online. It compares readings from these devices against the mean awake blood pressure obtained from ABPM.

How Is the Trial Designed?

Group I: Non-validated home BP device #1 Active Control 1 Intervention

BP measured with the first non-validated home BP device

Group II: Non-validated home BP device #3 Active Control 1 Intervention

BP measured with the third non-validated home BP device

Group III: Validate home BP device Active Control 1 Intervention

BP measured with a validated home BP device

Group IV: Non-validated home BP device #2 Active Control 1 Intervention

BP measured with the second non-validated home BP device

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials

17

Recruited

4,600+

Published Research Related to This Trial

Ambulatory blood pressure monitoring (ABPM) has become a crucial tool in assessing cardiovascular risk and guiding treatment decisions, showing greater prognostic value for hypertensive end-organ damage compared to traditional office blood pressure measurements.

With Medicare's new reimbursement plans for ABPM, its use is expected to rise, highlighting the need for clinicians to understand its role in managing hypertension effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure monitoring. Ernst, ME., Bergus, GR.[2005]

Ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM) provide more accurate and consistent blood pressure readings compared to traditional office measurements, which can often misrepresent a person's true blood pressure status.

Both ABPM and HBPM are important tools for diagnosing and managing hypertension, but they each have unique advantages and limitations that healthcare providers need to understand to optimize patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical implications of ambulatory and home blood pressure monitoring. Kim, SG.[2021]

Home blood pressure monitoring (HBPM) and 24-hour ambulatory blood pressure monitoring (ABPM) show similar effectiveness in controlling blood pressure and improving patient outcomes, based on a systematic review of 19 relevant studies.

HBPM is associated with better detection of optimal blood pressure control compared to office blood pressure monitoring, suggesting its routine use in clinical practice to enhance patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does home blood pressure monitoring improve patient outcomes? A systematic review comparing home and ambulatory blood pressure monitoring on blood pressure control and patient outcomes. Breaux-Shropshire, TL., Judd, E., Vucovich, LA., et al.[2022]

In a study of 103 children aged 11-19 with chronic kidney disease, attended home blood pressure measurements (HBPM) showed a high level of agreement (81.8%) with 24-hour ambulatory blood pressure monitoring (ABPM) in identifying abnormal blood pressure.

HBPM demonstrated higher sensitivity (87.5%) compared to specificity (77.4%), suggesting it is a reliable method for detecting high blood pressure, making it a feasible alternative for monitoring when ABPM is not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement between attended home and ambulatory blood pressure measurements in adolescents with chronic kidney disease. Glenn, TW., Eaton, CK., Psoter, KJ., et al.[2023]

In a study of 366 volunteers, the first reading of home blood pressure measurements (HBPM) was generally higher than subsequent readings, indicating that multiple measurements can improve accuracy in assessing blood pressure.

Ambulatory blood pressure measurements (ABPM) showed a wider range and tended to be higher than corresponding HBPMs, suggesting that ABPM may provide a more comprehensive view of a person's blood pressure throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of home and daytime ambulatory blood pressure measurements. Chrubasik-Hausmann, S., Chrubasik, C., Walz, B., et al.[2021]

Nocturnal high blood pressure can increase the risk of cardiovascular events, making accurate measurement of blood pressure at night crucial for hypertension management.

The new NightView home blood pressure monitoring device allows for both daytime and nighttime measurements, providing a more realistic assessment of blood pressure without significantly disturbing sleep, which could improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Nocturnal Blood Pressure and Sleep Quality in Hypertension Management. Cappuccio, FP.[2020]

In a study involving 1,079 participants from two major studies, measuring blood pressure (BP) two to four times during sleep can effectively estimate nocturnal hypertension, showing high agreement with full night ambulatory blood pressure monitoring (ABPM).

The best results were achieved by taking BP readings at 1, 2, 4, and 5 hours after falling asleep, yielding a kappa value of 0.84, indicating a strong correlation with nocturnal hypertension status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Number and timing of ambulatory blood pressure monitoring measurements. Jaeger, BC., Akinyelure, OP., Sakhuja, S., et al.[2023]

Ambulatory blood pressure monitoring (ABPM) provides a comprehensive 24-hour blood pressure profile in a patient's natural environment, which is more predictive of cardiovascular complications than traditional office measurements.

The absence of a normal decline in blood pressure during sleep, as detected by ABPM, is linked to higher risks of atherosclerosis and left ventricular hypertrophy, highlighting the importance of monitoring blood pressure patterns beyond the clinic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure monitoring: practical considerations. Lavie, CJ., Schmieder, RE., Messerli, FH.[2019]

In a study of 85 participants using home blood pressure devices, the average readings from these devices were close to those obtained through standard auscultation, with a mean difference of only -3.3 mm Hg for systolic pressure, indicating reasonable accuracy overall.

However, a significant number of devices (69%) showed differences of 5 mm Hg or more compared to the reference method, suggesting that many home BP devices may not provide sufficiently accurate readings for individual users, especially as arm circumference increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Assessment of the Accuracy of Home Blood Pressure Monitors When Used in Device Owners. Ringrose, JS., Polley, G., McLean, D., et al.[2018]

In a study of 54 patients, self-reported home blood pressure measurements (HBPM) were generally accurate, with 85% of patients showing a difference of no more than 4 mmHg compared to real measurements.

However, in 15% of patients, particularly those with lower education levels, significant discrepancies were noted, suggesting that automated blood pressure monitoring (ABPM) or devices with memory storage may provide more reliable data for managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of self-reported home blood pressure measurements with automatically stored values and ambulatory blood pressure. Nordmann, A., Frach, B., Walker, T., et al.[2019]

Citations

1.

validatebp.org

validatebp.org/

Validate BP: Home

The VDL is a free resource to help patients and physicians find blood pressure devices that have been validated for clinical accuracy. Supported by the AMA.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9867184/

Validations of Blood Pressure Measuring Devices Using ...

The aim of this study was to find out which blood pressure measuring devices have been adequately validated by the above protocols.

3.

health.harvard.edu

health.harvard.edu/staying-healthy/is-your-home-blood-pressure-monitor-accurate

Is your home blood pressure monitor accurate?

When home blood pressure monitors aren't validated for accuracy, there's no way to know if they provide accurate information.

4.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.20425

Validation of Blood Pressure Devices as per 2020 World ...

We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers.

5.

heart.org

heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home

Monitoring Your Blood Pressure at Home

You should monitor your blood pressure at home if you have been diagnosed with high blood pressure. · You should use an automatic, upper arm cuff ...

6.

ama-assn.org

ama-assn.org/delivering-care/hypertension/bp-monitoring-you-can-count-list-validated-devices-grows

BP monitoring you can count on—list of validated devices ...

The VDL supports the need for accurate and actionable BP measurements that can lead to appropriate hypertension treatment and improved blood ...

7.

fda.gov

fda.gov/medical-devices/safety-communications/do-not-use-unauthorized-devices-measuring-blood-pressure-fda-safety-communication

Do Not Use Unauthorized Devices for Measuring Blood ...

FDA alerts of risks with use of unauthorized blood pressure devices, which have not been reviewed for safety and effectiveness.