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NCT Number: NCT05552547

Home BP Monitoring

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.

Recruiting

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Goutham Rao, MD

CONTACT

[email protected]

(216)844-3791

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Blood Pressure Machine

Device

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

24-Hour Blood Pressure Machine

Device

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

Primary outcomes

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

    Time frame: Up to 2 weeks

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

    Time frame: Up to 24 hours

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

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

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

    Time frame: Up to 2 weeks

Secondary outcomes

  1. Number of subjects who complete home BP protocol

    Time frame: Up to 2 weeks

  2. Number of subjects who complete both home BP verus 24-hour ABPM protocols

    Time frame: Up to 3 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Goutham Rao, MD

CONTACT

[email protected]

(216)844-3791

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2022
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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