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NCT05552547 | Recruiting | High Blood Pressure


Home BP Monitoring
Sponsor:

Goutham Rao, MD

Information provided by (Responsible Party):

Goutham Rao, MD

Brief Summary:

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.

Condition or disease

High Blood Pressure

Intervention/treatment

Home Blood Pressure Machine

24-Hour Blood Pressure Machine

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 750 participants
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents
Actual Study Start Date : October 1, 2023
Estimated Primary Completion Date : October 21, 2025
Estimated Study Completion Date : October 21, 2025
Arm Intervention/treatment

Active Comparator: Home Blood Pressure Machine

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

Device: Home Blood Pressure Machine

Experimental: 24-Hour Blood Pressure Machine

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

Device: 24-Hour Blood Pressure Machine

Ages Eligible for Study: 13 Years to 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Self-identify or identified by a parent as African-American or of partly African American ancestry
Exclusion Criteria
  • Prior hypertension diagnosis
  • Prescribed BP medication
  • History of congenital heart disease
  • History of solid organ transplant
  • Prescribed and using stimulants and other medications on a regular basis known to raise blood pressure such as testosterone and nicotine replacement

Home BP Monitoring

Location Details


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Home BP Monitoring

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

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