NCT05552547

Home BP Monitoring

StatusRecruiting

PhaseNot applicable

SponsorUniversity Hospitals Cleveland Medical Center

Primary completionJun 1, 2027 (estimated)

At risk: Primary completion moved at least 8 months later.

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 9, 2026 Primary and study completion pushed from Sep 30, 2026 to Jun 1, 2027
- Eligibility criteria expanded, about 6 words
Notable Dec 2, 2025 Primary and study completion dates: Oct 21, 2025 to Sep 30, 2026
- Site contact updated
v6
Notable Feb 7, 2025 Lead sponsor: Goutham Rao, MD to University Hospitals Cleveland Medical Centerv5
Notable Feb 6, 2024 Trial status: Not Yet Recruiting to Recruiting
- Start date changed from estimate of Sep 1, 2023 to Oct 1, 2023
- Site details revised
v4
Notable Jul 20, 2023 Start date: May 2023 to Sep 1, 2023v3
Notable Apr 3, 2023 Start date: Jan 23, 2023 to May 2023v2
Sep 20, 2022 Study First Submitted

Notable: the plan changed

Endpoints

Primary

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

Timeframe: Up to 2 weeks

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

Timeframe: Up to 24 hours

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

Timeframe: Up to 2 weeks

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

Timeframe: Up to 2 weeks

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

Timeframe: Up to 2 weeks

Secondary (2)

Number of subjects who complete home BP protocol

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

Arms and interventions

Home Blood Pressure MachineActive comparator

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

24-Hour Blood Pressure MachineExperimental

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

Devices: Home Blood Pressure Machine, 24-Hour Blood Pressure Machine

Sites

1 site in 1 country

University Hospitals Cleveland Medical CenterCleveland, Ohio, United States

About 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.

Trial details

Enrollment: 750 participants (estimated)
Started: Oct 1, 2023
Study completion: Jun 1, 2027 (estimated)
Eligibility: 13 to 18, all sexes, healthy volunteers accepted
Design: Interventional, non-randomized, open label, prevention
Oversight: Data monitoring committee
Conditions: Hypertension, High Blood Pressure
Official title: Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents
First posted: Sep 23, 2022
Registry updated: Nov 13, 2026
Last verified: Nov 2026

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