High Blood PressureNCT05552547
Home BP Monitoring
A study testing Home Blood Pressure Machine and 24-Hour Blood Pressure Machine in people with High Blood Pressure, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Home Blood Pressure Machine and 24-Hour Blood Pressure Machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Self-identify or identified by a parent as African-American or of partly African American ancestry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Goutham Rao, MD, (216)844-3791, Goutham.Rao@UHhospitals.org
About this study
Official title: Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents
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.
- Conditions
- High Blood Pressure
- Being tested
- Home Blood Pressure Machine, 24-Hour Blood Pressure Machine
- Keywords
- African American Teen, Home blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood Pressure MachineDevice
Participants will be asked to measure blood pressure twice daily for three days in a row at home.
24-Hour Blood Pressure MachineDevice
Participants will be asked to wear the machine for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Home Blood Pressure Machine | Active comparator | Participants will be asked to measure blood pressure twice daily for three days in a row. Receives: Device: Home Blood Pressure Machine |
| 24-Hour Blood Pressure Machine | Experimental | Participants will be asked to wear this machine for 24 hours. Receives: Device: 24-Hour Blood Pressure Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who meet criteria for hypertension based on average home BP reading.
Measured: Up to 2 weeks
Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.
Measured: Up to 24 hours
Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM
Measured: Up to 2 weeks
True positive rate -- Number of home bp positives over ABPM positives
Measured: Up to 2 weeks
True negative rate -- Number of home bp negatives over ABPM negatives
Measured: Up to 2 weeks
Secondary outcomes (2)
Number of subjects who complete home BP protocol
Measured: Up to 2 weeks
Number of subjects who complete both home BP verus 24-hour ABPM protocols
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goutham Rao, MD, University Hospitals Cleveland Medical Center
- Investigators
- Rao Goutham, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552547
- Sponsor's protocol ID
- STUDY20221105
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents
- ClinicalTrials.gov ID
- NCT05552547
- Acronym / sponsor ID
- STUDY20221105
- Conditions
- High Blood Pressure
- Keywords
- African American Teen, Home blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Blood Pressure Machine | Active comparator | Device: Home Blood Pressure MachineParticipants will be asked to measure blood pressure twice daily for three days in a row. |
| 24-Hour Blood Pressure Machine | Experimental | Device: 24-Hour Blood Pressure MachineParticipants will be asked to wear this machine for 24 hours. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Self-identify or identified by a parent as African-American or of partly African American ancestry
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Blood Pressure MachineParticipants will be asked to measure blood pressure twice daily for three days in a row at home. | Device | Home Blood Pressure Machine |
| 24-Hour Blood Pressure MachineParticipants will be asked to wear the machine for 24 hours. | Device | 24-Hour Blood Pressure Machine |
Primary outcome
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 positive rate -- Number of home bp positives over ABPM positives
Time frame: Up to 2 weeks
True negative rate -- Number of home bp negatives over ABPM negatives
Time frame: Up to 2 weeks
2 secondary outcomes
Number of subjects who complete home BP protocol
Time frame: Up to 2 weeks
Number of subjects who complete both home BP verus 24-hour ABPM protocols
Time frame: Up to 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for High Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rao Goutham, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Pressure Machine and 24-Hour Blood Pressure Machine in people with High Blood Pressure, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Goutham Rao, MD ((216)844-3791, goutham.rao@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who meet criteria for hypertension based on average home BP reading. (time frame: Up to 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.