Recruiting

Blood Pressure

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05297708

Conditions

Elevated Blood Pressure

Eligibility Criteria

Sex: All

Age: 6 - 19

Healthy Volunteers: Not accepted

Study Details

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 ID

NCT05297708

Start date

Mar 24, 2022

Status verified date

Jun, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 19

Healthy Volunteers: Not accepted

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 Design

Enrollment

52 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Determine blood pressure phenotype [ Time Frame: 6-12 months after enrollment ]

Central Contacts and Locations

Central contacts

Locations

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Elaine Urbina

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-06-25.