Home BP Monitoring for High Blood Pressure
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.
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 data supports the effectiveness of the treatment Home BP Monitoring for High Blood Pressure?
Is home blood pressure monitoring safe for humans?
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.258910
Research Team
Rao Goutham, MD
Principal Investigator
University Hospitals Cleveland Medical Center
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Home Blood Pressure Monitoring
Participants will measure blood pressure twice daily for three days in a row using a home blood pressure machine
24-Hour Ambulatory Blood Pressure Monitoring
Participants will wear a 24-hour blood pressure machine for continuous monitoring
Follow-up
Participants are monitored for safety and effectiveness after blood pressure monitoring
Treatment Details
Interventions
- Home BP Monitoring (Behavioural Intervention)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Hospitals Cleveland Medical Center
Lead Sponsor
Dr. Brett Glotzbecker
University Hospitals Cleveland Medical Center
Chief Medical Officer since 2023
MD
Dr. Cliff Megerian
University Hospitals Cleveland Medical Center
Chief Executive Officer
MD, MBA
Goutham Rao, MD
Lead Sponsor