Office, Home, and Ambulatory Blood Pressure

NCT ID: NCT05297708

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2026-09-01

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.

Conditions

Elevated Blood Pressure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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;

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Urbina

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2021-0843

Identifier Type: -

Identifier Source: org_study_id