Home BP Device Accuracy for High Blood Pressure

(VALID-HomeBP Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

This study aims to assess whether validated and non-validated blood pressure measuring devices sold on the online market are accurate in regards to the mean awake BP from ambulatory 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 data supports the effectiveness of the treatment awake ABPM for high blood pressure?

Ambulatory blood pressure monitoring (ABPM) is shown to provide a more accurate and reliable estimate of blood pressure compared to traditional office measurements, which helps in better predicting cardiovascular outcomes and managing high blood pressure. ^{1 2 3 4 5}

Is home blood pressure monitoring safe for humans?

The research does not specifically address safety concerns, but home blood pressure monitoring is widely used in clinical practice for managing high blood pressure, suggesting it is generally considered safe. ^{1 5 6 7 8}

How does awake ABPM differ from other treatments for high blood pressure?

Awake ambulatory blood pressure monitoring (ABPM) is unique because it measures blood pressure continuously over a 24-hour period in a person's natural environment, capturing variations due to daily activities and emotional states, unlike traditional office measurements that can be affected by stress. This method provides a more accurate picture of blood pressure patterns, especially during waking hours, and helps identify 'white coat' hypertension, where blood pressure is elevated in a clinical setting but not in everyday life. ^{1 7 8 9 10}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and scheduled for a 24-hour blood pressure monitoring.

Exclusion Criteria

Contraindication to measure BP on the non-dominant arm

Ongoing pregnancy

Inability or unwillingness to provide consent

Trial Timeline

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

Treatment Details

Interventions

• awake ABPM (Diagnostic Test)

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

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

2. New Zealand 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure monitoring. [2005]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

Agreement between attended home and ambulatory blood pressure measurements in adolescents with chronic kidney disease. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Comparisons of home and daytime ambulatory blood pressure measurements. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Comparison of self-reported home blood pressure measurements with automatically stored values and ambulatory blood pressure. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

An Assessment of the Accuracy of Home Blood Pressure Monitors When Used in Device Owners. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Number and timing of ambulatory blood pressure monitoring measurements. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure monitoring: practical considerations. [2019]