750 Participants Needed

Home BP Monitoring for High Blood Pressure

GR
Overseen ByGoutham Rao, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to identify high blood pressure in African American teens. Instead of the usual doctor visits, participants will use a home blood pressure machine to check their readings twice a day for three days. Researchers will compare these results with those from a 24-hour monitoring device, considered the gold standard for accuracy. Teens who are African American or partly African American and have not been previously diagnosed with high blood pressure are ideal candidates for this study. The trial also aims to gather feedback from participants and their parents on their experiences with both methods. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve blood pressure monitoring for teens.

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.

What prior data suggests that this method is safe for teens?

Research shows that checking blood pressure at home can be a safe and effective method. This approach allows individuals to measure blood pressure in a comfortable setting, such as their own home, which can help avoid the stress or anxiety some people experience at the doctor's office, often leading to higher readings.

Studies have found 24-hour ambulatory blood pressure monitoring (ABPM) to be well-tolerated and reliable for tracking blood pressure throughout the day and night. This method is often used to manage high blood pressure because it provides a complete picture of how blood pressure changes over time.

Both methods are widely used and considered safe. They offer a better understanding of blood pressure levels and help avoid the limitations of measuring blood pressure only at the doctor's office.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new methods for managing high blood pressure at home. The trial compares traditional home blood pressure machines, where participants measure their blood pressure twice daily, with an experimental 24-hour blood pressure monitoring device that is worn continuously. This new 24-hour monitoring approach could provide more comprehensive data by capturing fluctuations in blood pressure throughout the entire day, offering insights that occasional measurements might miss. By understanding these patterns better, the trial aims to refine hypertension management and improve patient outcomes.

What evidence suggests that this trial's methods could be effective for identifying high blood pressure in teens?

Research has shown that checking blood pressure over 24 hours with a portable monitor, which participants in this trial may use, provides very accurate results. This method is the best choice for measuring blood pressure because it offers detailed and reliable information. Studies have found that it diagnoses high blood pressure more effectively than taking readings only at the doctor's office. Alternatively, another group in this trial will use home blood pressure monitoring, a convenient option, especially for teenagers. In Europe, this method has successfully identified high blood pressure outside of clinics. Although not as extensively studied as the 24-hour method, home monitoring can still provide useful information, particularly when regular clinic visits are difficult.12367

Who Is on the Research Team?

RG

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: 24-Hour Blood Pressure MachineExperimental Treatment1 Intervention
Group II: Home Blood Pressure MachineActive Control1 Intervention

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:
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Approved in United States as Home Blood Pressure Monitoring for:

Find a Clinic Near You

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

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

Citations

Twenty-Four-Hour Ambulatory Blood Pressure MonitoringCurrent evidence indicates that 24-hour ambulatory blood pressure monitoring should be an integral part of hypertension care.
Twenty-Four-Hour Ambulatory Blood Pressure Monitoring ...The objective of this health technology assessment was to determine the clinical effectiveness and cost-effectiveness of 24-hour ambulatory blood pressure ...
Ambulatory Blood Pressure Monitoring to Diagnose and ...This review portrays how ambulatory blood pressure (BP) monitoring was established and recommended as the method of choice for the assessment of BP.
24-Hour Ambulatory Blood Pressure MonitoringAmbulatory blood pressure monitoring is an accurate and effective way to measure your blood pressure. It gives your healthcare provider better data compared ...
Ambulatory blood pressure monitoring, European guideline ...Median 24-h PTTR was 18% (interquartile range 5–33) corresponding to 4.3 h (1.2–7.9). Over 10.9 years (median), deaths (N = 3117) and ...
Twenty‐Four‐Hour Ambulatory Blood Pressure Profile in ...Patients with reflex syncope have lower 24-hour SBP but higher 24-hour diastolic BP and more frequent daytime SBP drops <90 mm Hg than individuals without ...
Ambulatory Blood Pressure Monitoring (ABPM)The authors concluded that ABPM (24-hour, daytime, or nighttime) is a better predictor of long-term CV outcomes than OBPM (manual sphygmomanometry) and should ...
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