Office, Home, and Ambulatory Blood Pressure

Study Overview
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Brief Summary
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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.

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

Conditions
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Elevated Blood Pressure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Corticosteroids Calcineurin inhibitors Oral decongestants; Clinically stable Exclusion Criteria: On antihypertension medications or treated in the last 6 months; Pregnant; Structural heart disease such as: Obstructive valvular disease Coarctation of the aorta Cardiomyopathy; 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;

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6-12 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6-12 months after enrollment |