Office, Home, and Ambulatory Blood Pressure

Office, Home, and Ambulatory Blood Pressure Measurements in Pediatric Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05297708

Acronym

HBPA

Enrollment

Registered

2022-03-28

Start date

2022-03-24

Completion date

2028-01-01

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated Blood Pressure

Brief 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 hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 19 Years

Inclusion criteria

1. Age 6 years to \<19 years old; 2. 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; 3. Tolerate ABPM 24 hours; 4. Tolerate HBP; and 5. Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication. 6. On stable doses of medications known to affect BP such as: 1. Corticosteroids 2. Calcineurin inhibitors 3. Oral decongestants; 7. Clinically stable

Exclusion criteria

1. On antihypertension medications or treated in the last 6 months; 2. Pregnant; 3. Structural heart disease such as: 1. Obstructive valvular disease 2. Coarctation of the aorta 3. Cardiomyopathy; 4. Other secondary causes such as: 1. Renal artery stenosis 2. Neurological condition with dysautonomia; 5. Recent initiation of medications known to affect BP such as: 1. Corticosteroids 2. Calcineurin inhibitors 3. Oral decongestants;

Design outcomes

Primary

Measure	Time frame	Description
Determine blood pressure phenotype	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.

Secondary

Measure	Time frame	Description
HBP correlation with end organ damage	6-12 months after enrollment	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.

Countries

United States

Contacts

CONTACTMary Banks

mary.banks@cchmc.org15136362147

PRINCIPAL_INVESTIGATORElaine Urbina

Children's Hospital Medical Center, Cincinnati

Outcome results