Home BP Monitoring for High Blood Pressure

Overseen By Goutham Rao, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Stimulants, Testosterone, Nicotine

Disqualifiers: Hypertension, Heart disease, Organ transplant, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Most cases of high blood pressure in teens are missed for a number of reasons. One reason is that the most common way to make a diagnosis is to make three or more blood pressure measurements in a doctor's office on separate days. This can be inconvenient. Also, measuring blood pressure in the office might be inaccurate, since children (including teens) might have high values in the office but normal values at home. For these reasons, investigators wish to study a different way to identify teens with high blood pressure. Home BP measurements have been used in Europe to make a diagnosis, but not yet in the United States, and never in a higher risk population of teens. African American teens are at higher risk for high blood pressure than other teens. Investigators will compare the values received from the home BP machines to another method (24 hour ambulatory BP monitoring or ABPM) which is the best standard for diagnosis. Investigators also want to learn more about participants experience and their child's experience with both methods. A small sample of participating teens and parents will be invited to participate in short telephone interviews. This study plans to enroll a total of 750 teens at UH. Recruitment will not take place from other organizations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are already prescribed blood pressure medication or regularly use stimulants or other medications that raise blood pressure, you would not be eligible to participate.

Is home blood pressure monitoring safe for humans?

Home blood pressure monitoring (HBPM) is generally considered safe for humans. It is a reliable and convenient method for managing high blood pressure, and there is no evidence suggesting it poses any safety risks. ^{1 2 3 4 5}

How is home blood pressure monitoring different from other treatments for high blood pressure?

Home blood pressure monitoring (HBPM) is unique because it allows patients to measure their blood pressure at home, providing more frequent and accurate readings than those taken in a doctor's office. This method helps avoid the 'white-coat effect' (where blood pressure rises in a clinical setting) and better predicts cardiovascular risk by offering readings closer to those from 24-hour monitoring. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Home BP Monitoring for High Blood Pressure?

Research shows that home blood pressure monitoring (HBPM) helps people control their blood pressure better and stick to their medication plans. It provides more data for doctors and patients to manage high blood pressure effectively. ^{1 4 5 9 10}

Who Is on the Research Team?

Rao Goutham, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for African American teens without a prior hypertension diagnosis, no history of organ transplant, not on stimulants or blood pressure meds, and no congenital heart disease. It aims to find better ways to diagnose high blood pressure in this group.

Inclusion Criteria

You or your parent have identified as African-American or partly African-American.

Exclusion Criteria

I have had a solid organ transplant.

I have been diagnosed with high blood pressure.

I was born with a heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Blood Pressure Monitoring

Participants will measure blood pressure twice daily for three days in a row using a home blood pressure machine

1 week

No in-person visits required

24-Hour Ambulatory Blood Pressure Monitoring

Participants will wear a 24-hour blood pressure machine for continuous monitoring

1 day

1 visit (in-person) for device setup and removal

Follow-up

Participants are monitored for safety and effectiveness after blood pressure monitoring

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home BP Monitoring

Trial Overview The study compares home blood pressure monitoring with the gold standard 24-hour ambulatory BP monitoring (ABPM) to see which is more effective at diagnosing high blood pressure in African American teens.

How Is the Trial Designed?

Group I: 24-Hour Blood Pressure Machine Experimental Treatment 1 Intervention

Participants will be asked to wear this machine for 24 hours.

Group II: Home Blood Pressure Machine Active Control 1 Intervention

Participants will be asked to measure blood pressure twice daily for three days in a row.

Home BP Monitoring is already approved in European Union, United States for the following indications:

Approved in European Union as Home Blood Pressure Monitoring for:

• Diagnosis of hypertension in children and adolescents

Approved in United States as Home Blood Pressure Monitoring for:

• Under investigation for diagnosis of hypertension in children and adolescents, particularly in high-risk populations

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Goutham Rao, MD

Lead Sponsor

Trials

1

Recruited

750+

Published Research Related to This Trial

In a study of 6,320 adults with hypertension, those who received a physician's recommendation for home blood pressure monitoring (HBPM) had significantly lower blood pressure, averaging 3.1/4.5 mm Hg lower than those without such recommendations.

Patients who used HBPM after receiving a physician's recommendation were nearly three times more likely to adhere to their hypertension medication, highlighting the importance of physician involvement in encouraging HBPM for better blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Physician Recommendation of Home Blood Pressure Monitoring and Blood Pressure in the US Population. Tang, O., Foti, K., Miller, ER., et al.[2021]

A study of 452 hypertensive patients in Turkey revealed that most patients chose their home sphygmomanometers based on simplicity and ease of use, rather than on their accuracy or validation status.

None of the patients were aware of whether their home sphygmomanometers were validated or calibrated, indicating a significant gap in knowledge that could lead to inaccurate blood pressure readings and potential mismanagement of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do we measure blood pressure at home? Bardak, S., Turgutalp, K., Özcan, T., et al.[2015]

In a study of 213 adults with hypertension over 3 months, home blood pressure monitoring (HBPM) combined with a health education session did not significantly reduce blood pressure or improve medication adherence compared to usual care.

While the HBPM group showed some reduction in blood pressure, it was not greater than the control group, suggesting that more effective educational interventions and sharing blood pressure data might enhance outcomes in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. Cuffee, YL., Sciamanna, C., Gerin, W., et al.[2022]

In a study involving 100 Alaska Native and American Indian participants with hypertension, the majority (66%) preferred wrist blood pressure monitoring devices over arm devices due to higher ratings in ease of use and comfort.

Despite valuing accuracy in home blood pressure monitoring, participants prioritized usability factors like comfort and ease of use when choosing a device, indicating that these characteristics are crucial for long-term management of hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. Railey, AF., Dillard, DA., Fyfe-Johnson, A., et al.[2023]

Home blood pressure monitoring (HmBPM) leads to a moderate but statistically significant reduction in both systolic and diastolic blood pressure compared to ambulatory and hospital monitoring, with reductions ranging from -2.50 mmHg to -4.25 mmHg for systolic and -1.45 mmHg to -2.37 mmHg for diastolic pressure.

The effectiveness of HmBPM in managing hypertension is influenced by the patient's ability to accurately perform and interpret the measurements, as well as how healthcare professionals utilize this data to adjust treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of blood pressure home monitoring. Synopsis of systematic reviews.] Re, LG., Fusetti, V.[2022]

Home blood pressure monitoring (HBPM) is a reliable and cost-effective method for diagnosing and managing hypertension, with strong recommendations for its use alongside ambulatory blood pressure monitoring (ABPM) in current guidelines.

HBPM provides critical data that can predict cardiovascular disease and stroke-related risks better than traditional office blood pressure measurements, helping to optimize treatment and reduce target organ damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Blood Pressure Monitoring: Current Status and New Developments. Kario, K.[2023]

A survey of 643 hypertensive patients revealed that while 71% were informed about home blood pressure monitoring (HBPM), many did not follow the recommended procedures, leading to inaccurate measurements.

Patients who correctly followed HBPM guidelines showed significantly better measurement practices, which were associated with a lower prevalence of carotid plaque, highlighting the importance of proper technique for effective hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of home blood pressure measurement: the ACCURAPRESS study - a proposal of Young Investigator Group of the Italian Hypertension Society (Società Italiana dell'Ipertensione Arteriosa). Mancusi, C., Bisogni, V., Maloberti, A., et al.[2022]

Home blood pressure monitoring (HBPM) is recommended as a routine practice for most patients with known or suspected hypertension, as it provides more accurate and reproducible readings compared to traditional office measurements, helping to better predict cardiovascular risk.

Patients should use validated oscillometric monitors for HBPM, taking multiple readings over a week to inform clinical decisions, which can also aid in distinguishing between white-coat and sustained hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to action on use and reimbursement for home blood pressure monitoring: executive summary a joint scientific statement from the american heart association, american society of hypertension, and preventive cardiovascular nurses association. Pickering, TG., Miller, NH., Ogedegbe, G., et al.[2010]

Home blood pressure monitoring (HBPM) is recommended as a routine practice for most patients with hypertension, as it provides more accurate and reproducible readings compared to traditional office measurements, helping to better predict cardiovascular risk.

Patients should use validated oscillometric monitors for HBPM, taking multiple readings over a week to inform clinical decisions, which can improve treatment adherence and overall blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. Pickering, TG., Miller, NH., Ogedegbe, G., et al.[2022]

Home blood pressure monitoring (HBPM) is recommended as a routine practice for most patients with hypertension, as it provides more accurate and reproducible readings compared to traditional office measurements, helping to better predict cardiovascular risk.

Patients should use validated oscillometric monitors for HBPM, taking multiple readings over a week to inform clinical decisions, which can also enhance treatment adherence and improve overall care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Call to action on use and reimbursement for home blood pressure monitoring: Executive Summary. A joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. Pickering, TG., Miller, NH., Ogedegbe, G., et al.[2021]

Citations

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

Factors Associated With Physician Recommendation of Home Blood Pressure Monitoring and Blood Pressure in the US Population. [2021]

2. England pubmed.ncbi.nlm.nih.gov

How do we measure blood pressure at home? [2015]

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

The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. [2022]

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

Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

[Effectiveness of blood pressure home monitoring. Synopsis of systematic reviews.] [2022]

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

Home Blood Pressure Monitoring: Current Status and New Developments. [2023]

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

Accuracy of home blood pressure measurement: the ACCURAPRESS study - a proposal of Young Investigator Group of the Italian Hypertension Society (Società Italiana dell'Ipertensione Arteriosa). [2022]

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

Call to action on use and reimbursement for home blood pressure monitoring: executive summary a joint scientific statement from the american heart association, american society of hypertension, and preventive cardiovascular nurses association. [2010]

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

Call to action on use and reimbursement for home blood pressure monitoring: a joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. [2022]

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

Call to action on use and reimbursement for home blood pressure monitoring: Executive Summary. A joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. [2021]