Elevated Blood PressureHBPANCT05297708
Office, Home, and Ambulatory Blood Pressure
An observational study of Elevated Blood Pressure, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This will be a prospective observational study. The population would be pediatric patients 6 years to <19 years of age who were referred for elevated blood pressure to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat… Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- Elevated Blood Pressure
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2022to 1 Jan 2028
- Phase
- Observational
- 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 6 to 19 years
- All sexes
- Child, Adult
Study population: The population will be pediatric patients 6 years to <19 years years of age who were referred for elevated blood pressure to the Recruitment Hypertension clinic, Lipid Clinic, or Center for Better Health and Nutrition.
Who may be able to join
- Age 6 years to <19 years old;
- Elevated blood pressure defined as 15% lower than the 95%ile BP based on clinical practice guidelines(CPG) but less than stage II hypertension based on CPG;
- Tolerate ABPM 24 hours;
- Tolerate HBP; and
- Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.
- On stable doses of medications known to affect BP such as:
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- Corticosteroids
- Calcineurin inhibitors
- Oral decongestants;
- Clinically stable
Who cannot join
- On antihypertension medications or treated in the last 6 months;
- Pregnant;
- Structural heart disease such as:
- Obstructive valvular disease
- Coarctation of the aorta
- Cardiomyopathy;
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- Other secondary causes such as:
- Renal artery stenosis
- Neurological condition with dysautonomia;
- Recent initiation of medications known to affect BP such as:
- Corticosteroids
- Calcineurin inhibitors
- Oral decongestants;
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
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Elaine Urbina, 513-636-8265, elaine.urbina@cchmc.org
Elaine Urbina
About this study
Official title: Office, Home, and Ambulatory Blood Pressure Measurements in Pediatric Patients
This will be a prospective observational study. The population would be pediatric patients 6 years to <19 years of age who were referred for elevated blood pressure to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.
- Conditions
- Elevated Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | he population would be pediatric patients 6 years to <19 years of age who were referred for elevated blood pressure. At the initial clinic visit, the participant will be consented and a thorough history will be taken. An ECHO and non-invasive vascular measurements will be taken (central BP, augmentation index, pulse wave velocity). Patients will have an ambulatory blood pressure monitor (ABPM) placed and be trained to use a home blood pressure monitor (HBP) which will be sent home with them. The monitors in this study are FDA-approved and are being used as indicated. After one day at home, patients will return the ABPM via mail and continue to take measurements with the HBP for 20 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine blood pressure phenotype
The primary objective of this study is to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.
Measured: 6-12 months after enrollment
Secondary outcomes (1)
HBP correlation with end organ damage
Our secondary objective is to determine if HBP correlates with end organ damage (i.e. elevated left ventricular mass, increased arterial stiffness, and decreased left ventricular strain) better than office BP. Our central hypothesis is that home blood pressure will accurately identify blood pressure phenotype and will correlate with end organ damage.
Measured: 6-12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start24 Mar 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Urbina, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297708
- Sponsor's protocol ID
- 2021-0843
- Acronym
- HBPA
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2022
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office, Home, and Ambulatory Blood Pressure Measurements in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05297708
- Acronym / sponsor ID
- HBPA / 2021-0843
- Conditions
- Elevated Blood Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 28 Mar 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.
This will be a prospective observational study. The population would be pediatric patients 6 years to <19 years of age who were referred for elevated blood pressure to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –he population would be pediatric patients 6 years to <19 years of age who were referred for elevated blood pressure. At the initial clinic visit, the participant will be consented and a thorough history will be taken. An ECHO and non-invasive vascular measurements will be taken (central BP, augmentation index, pulse wave velocity). Patients will have an ambulatory blood pressure monitor (ABPM) placed and be trained to use a home blood pressure monitor (HBP) which will be sent home with them. The monitors in this study are FDA-approved and are being used as indicated. After one day at home, patients will return the ABPM via mail and continue to take measurements with the HBP for 20 days. |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The population will be pediatric patients 6 years to <19 years years of age who were referred for elevated blood pressure to the Recruitment Hypertension clinic, Lipid Clinic, or Center for Better Health and Nutrition.
Key inclusion criteria (10 listed)
- Age 6 years to <19 years old;
- Elevated blood pressure defined as 15% lower than the 95%ile BP based on clinical practice guidelines(CPG) but less than stage II hypertension based on CPG;
- Tolerate ABPM 24 hours;
- Tolerate HBP; and
- Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.
Key exclusion criteria (13 listed)
- On antihypertension medications or treated in the last 6 months;
- Pregnant;
- Structural heart disease such as:
- Other secondary causes such as:
- Recent initiation of medications known to affect BP such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine blood pressure phenotype
Time frame: 6-12 months after enrollment
The primary objective of this study is to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.
1 secondary outcome
HBP correlation with end organ damage
Time frame: 6-12 months after enrollment
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 25 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Elaine Urbina principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Blood Pressure, run by Children's Hospital Medical Center, Cincinnati 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 10 inclusion and 13 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 25 Jun 2026. 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 Mary Banks (15136362147, mary.banks@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine blood pressure phenotype (time frame: 6-12 months after enrollment). 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 25 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.