Trial Summary
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.
Is Home BP Monitoring a promising treatment for high blood pressure?Yes, Home BP Monitoring is a promising treatment for high blood pressure. It is cheaper, easier, and more accurate than traditional office measurements. It helps in getting more reliable readings by avoiding the 'white-coat effect' (where blood pressure rises in a doctor's office). It also predicts health risks better and can improve how well people stick to their treatment plans.12345
Do I need to stop my current medications to join the trial?The trial does not specify if you need to stop your current medications, but you cannot participate if you are already prescribed BP medication or certain other medications that raise blood pressure.
What safety data exists for home blood pressure monitoring?The research does not directly address safety data for home blood pressure monitoring (HBPM). However, it highlights HBPM as a reliable and effective tool for managing hypertension, with benefits such as improved blood pressure control and reduced cardiovascular risk. The accuracy and reliability of HBPM depend on using validated devices and standardized procedures. While the studies emphasize the importance of proper technique and device characteristics, they do not specifically discuss safety concerns or adverse effects related to HBPM.458910
What data supports the idea that Home BP Monitoring for High Blood Pressure is an effective treatment?The available research shows that Home Blood Pressure Monitoring (HBPM) is effective in managing high blood pressure. One study found that using HBPM, especially when recommended by a doctor, is linked to lower blood pressure and better adherence to medication. Another study highlighted that HBPM, combined with health education, helps reduce blood pressure and improves how well people stick to their medication plans. Overall, HBPM is seen as a valuable tool for controlling blood pressure and managing hypertension over the long term.45679
Eligibility Criteria
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.Exclusion Criteria
I have had a solid organ transplant.
I have been diagnosed with high blood pressure.
I was born with a heart condition.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: 24-Hour Blood Pressure MachineExperimental Treatment1 Intervention
Participants will be asked to wear this machine for 24 hours.
Group II: Home Blood Pressure MachineActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
University Hospitals Cleveland Medical CenterCleveland, OH
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Who is running the clinical trial?
Goutham Rao, MDLead Sponsor
References
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]Home blood pressure monitoring (HBPM) overcomes many of the limitations of traditional office blood pressure (BP) measurement and is both cheaper and easier to perform than ambulatory BP monitoring. Monitors that use the oscillometric method are currently available that are accurate, reliable, easy to use, and relatively inexpensive. An increasing number of patients are using them regularly to check their BP at home, but although this has been endorsed by national and international guidelines, detailed recommendations for their use have been lacking. There is a rapidly growing literature showing that measurements taken by patients at home are often lower than readings taken in the office and closer to the average BP recorded by 24-hour ambulatory monitors, which is the BP that best predicts cardiovascular risk. Because of the larger numbers of readings that can be taken by HBPM than in the office and the elimination of the white-coat effect (the increase of BP during an office visit), home readings are more reproducible than office readings and show better correlations with measures of target organ damage. In addition, prospective studies that have used multiple home readings to express the true BP have found that home BP predicts risk better than office BP (class IIa; level of evidence A). This call-to-action article makes the following recommendations: (1) It is recommended that HBPM should become a routine component of BP measurement in the majority of patients with known or suspected hypertension; (2) Patients should be advised to purchase oscillometric monitors that measure BP on the upper arm with an appropriate cuff size and that have been shown to be accurate according to standard international protocols. They should be shown how to use them by their healthcare providers; (3) Two to 3 readings should be taken while the subject is resting in the seated position, both in the morning and at night, over a period of 1 week. A total of > or =12 readings are recommended for making clinical decisions; (4) HBPM is indicated in patients with newly diagnosed or suspected hypertension, in whom it may distinguish between white-coat and sustained hypertension. If the results are equivocal, ambulatory BP monitoring may help to establish the diagnosis; (5) In patients with prehypertension, HBPM may be useful for detecting masked hypertension; (6) HBPM is recommended for evaluating the response to any type of antihypertensive treatment and may improve adherence; (7) The target HBPM goal for treatment is
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]Home blood pressure monitoring (HBPM) overcomes many of the limitations of traditional office blood pressure (BP) measurement and is both cheaper and easier to perform than ambulatory BP monitoring. Monitors that use the oscillometric method are currently available that are accurate, reliable, easy to use, and relatively inexpensive. An increasing number of patients are using them regularly to check their BP at home, but although this has been endorsed by national and international guidelines, detailed recommendations for their use have been lacking. There is a rapidly growing literature showing that measurements taken by patients at home are often lower than readings taken in the office and closer to the average BP recorded by 24-hour ambulatory monitors, which is the BP that best predicts cardiovascular risk. Because of the larger numbers of readings that can be taken by HBPM than in the office and the elimination of the white-coat effect (the increase of BP during an office visit), home readings are more reproducible than office readings and show better correlations with measures of target organ damage. In addition, prospective studies that have used multiple home readings to express the true BP have found that home BP predicts risk better than office BP (Class IIa; Level of Evidence A). This call-to-action article makes the following recommendations: (1) It is recommended that HBPM should become a routine component of BP measurement in the majority of patients with known or suspected hypertension; (2) Patients should be advised to purchase oscillometric monitors that measure BP on the upper arm with an appropriate cuff size and that have been shown to be accurate according to standard international protocols. They should be shown how to use them by their healthcare providers; (3) Two to 3 readings should be taken while the subject is resting in the seated position, both in the morning and at night, over a period of 1 week. A total of >/=12 readings are recommended for making clinical decisions; (4) HBPM is indicated in patients with newly diagnosed or suspected hypertension, in whom it may distinguish between white-coat and sustained hypertension. If the results are equivocal, ambulatory BP monitoring may help to establish the diagnosis; (5) In patients with prehypertension, HBPM may be useful for detecting masked hypertension; (6) HBPM is recommended for evaluating the response to any type of antihypertensive treatment and may improve adherence; (7) The target HBPM goal for treatment is
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]Home blood pressure monitoring (HBPM) overcomes many of the limitations of traditional office blood pressure (BP) measurement and is both cheaper and easier to perform than ambulatory BP monitoring. Monitors that use the oscillometric method are currently available that are accurate, reliable, easy to use, and relatively inexpensive. An increasing number of patients are using them regularly to check their BP at home, but although this has been endorsed by national and international guidelines, detailed recommendations for their use have been lacking. There is a rapidly growing literature showing that measurements taken by patients at home are often lower than readings taken in the office and closer to the average BP recorded by 24-hour ambulatory monitors, which is the BP that best predicts cardiovascular risk. Because of the larger numbers of readings that can be taken by HBPM than in the office and the elimination of the white-coat effect (the increase of BP during an office visit), home readings are more reproducible than office readings and show better correlations with measures of target organ damage. In addition, prospective studies that have used multiple home readings to express the true BP have found that home BP predicts risk better than office BP (class IIa; level of evidence A). This call-to-action article makes the following recommendations: 1) It is recommended that HBPM should become a routine component of BP measurement in the majority of patients with known or suspected hypertension; 2) Patients should be advised to purchase oscillometric monitors that measure BP on the upper arm with an appropriate cuff size and that have been shown to be accurate according to standard international protocols. They should be shown how to use them by their healthcare providers; 3) Two to three readings should be taken while the subject is resting in the seated position, both in the morning and at night, over a period of 1 week. A total of >/=12 readings are recommended for making clinical decisions; 4) HBPM is indicated in patients with newly diagnosed or suspected hypertension, in whom it may distinguish between white-coat and sustained hypertension. If the results are equivocal, ambulatory BP monitoring may help to establish the diagnosis; 5) In patients with prehypertension, HBPM may be useful for detecting masked hypertension; 6) HBPM is recommended for evaluating the response to any type of antihypertensive treatment and may improve adherence; 7) The target HBPM goal for treatment is
How do we measure blood pressure at home? [2015]Home blood pressure monitoring (HBPM) is one of the measures that increases compliance with antihypertensive therapy. HBPM requires a proper measurement technique as well as an accurate sphygmomanometer. The aim of this study was to assess the characteristics of home sphygmomanometers (HS) in a big city in Turkey.
[Effectiveness of blood pressure home monitoring. Synopsis of systematic reviews.] [2022]Home blood pressure monitoring (HmBPM) is as a valuable and useful tool for hypertension management; some uncertainties remain about benefits of intervention in clinical practice.
The Effectiveness of Home Blood Pressure on 24-Hour Blood Pressure Control: A Randomized Controlled Trial. [2022]Home blood pressure monitoring (HBPM) is cited as an effective approach for improving blood pressure control. The objective of this study was to determine the effectiveness of HBPM combined with a health education session in reducing blood pressure and improving medication adherence among adults with hypertension.
Factors Associated With Physician Recommendation of Home Blood Pressure Monitoring and Blood Pressure in the US Population. [2021]Hypertension guidelines recommend home blood pressure monitoring (HBPM) to help achieve blood pressure (BP) control. We hypothesized that HBPM use with a physician recommendation would be associated with lower BP and greater medication adherence.
Home Blood Pressure Monitoring: Current Status and New Developments. [2023]Home blood pressure monitoring (HBPM) is a reliable, convenient, and less costly alternative to ambulatory blood pressure monitoring (ABPM) for the diagnosis and management of hypertension. Recognition and use of HBPM have dramatically increased over the last 20 years and current guidelines make strong recommendations for the use of both HBPM and ABPM in patients with hypertension. The accuracy and reliability of home blood pressure (BP) measurements require use of a validated device and standardized procedures, and good patient information and training. Key HBPM parameters include morning BP, evening BP, and the morning-evening difference. In addition, newer semi-automatic HBPM devices can also measure nighttime BP at fixed intervals during sleep. Advances in technology mean that HBPM devices could provide additional relevant data (e.g., environmental conditions) or determine BP in response to a specific trigger (e.g., hypoxia, increased heart rate). The value of HBPM is highlighted by a growing body of evidence showing that home BP is an important predictor of target organ damage, and cardiovascular disease (CVD)- and stroke-related morbidity and mortality, and provides better prognostic information than office BP. In addition, use of HBPM to monitor antihypertensive therapy can help to optimize reductions in BP, improve BP control, and reduce target organ damage and cardiovascular risk. Overall, HBPM should play a central role in the management of patients with hypertension, with the goal of identifying increased risk and predicting the onset of CVD events, allowing proactive interventions to reduce risk and eliminate adverse outcomes.
Choice of home blood pressure monitoring device: the role of device characteristics among Alaska Native and American Indian peoples. [2023]Home blood pressure monitoring (HBPM) is an effective tool in treatment and long-term management of hypertension. HBPM incorporates more data points to help patients and providers with diagnosis and management. The characteristics of HBPM devices matter to patients, but the relative importance of the characteristics in choosing a device remains unclear.
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]Home blood pressure monitoring (HBPM) might be considered a valid alternative to ambulatory blood pressure monitoring (ABPM) for both the diagnosis and management of hypertension. Correct information on how to perform HBPM are crucial for its reliability. The aim of the present survey was to assess if hypertensive patients followed current recommendation on how to correctly perform HBPM measurements.