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Clinical Trials/NCT05552547
NCT05552547RecruitingNot Applicable

Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents

University Hospitals Cleveland Medical Center2 sites in 1 country750 target enrollmentStarted: October 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
750
Locations
2
Primary Endpoint
Number of participants who meet criteria for hypertension based on average home BP reading.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
13 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Number of participants who meet criteria for hypertension based on average home BP reading.

Time Frame: Up to 2 weeks

Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.

Time Frame: Up to 24 hours

Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM

Time Frame: Up to 2 weeks

True negative rate -- Number of home bp negatives over ABPM negatives

Time Frame: Up to 2 weeks

True positive rate -- Number of home bp positives over ABPM positives

Time Frame: Up to 2 weeks

Secondary Outcomes

  • Number of subjects who complete home BP protocol(Up to 2 weeks)
  • Number of subjects who complete both home BP verus 24-hour ABPM protocols(Up to 3 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Goutham Rao, MD

Chairman, Department of Family Medicine and Community Health

University Hospitals Cleveland Medical Center

Study Sites (2)

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