Office, Home, and Ambulatory Blood Pressure (HBPA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Elevated Blood Pressure

• Study Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Elaine Urbina, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 2021-0843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No