Evaluating blood pressure measurements in children and adolescents

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

This study is testing if measuring blood pressure at home can help doctors better understand different blood pressure conditions in kids and teens who have high blood pressure.

Quick facts

• Study type: Observational
• Enrollment: 52 (estimated)
• Ages: 6 Years to 19 Years
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (Academic / other)
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT05297708 on ClinicalTrials.gov

What this trial studies

This observational study focuses on pediatric patients aged 6 to less than 19 years who have been referred for elevated blood pressure. It aims to determine whether home blood pressure monitoring can accurately identify blood pressure phenotypes, such as normotensive, hypertensive, masked hypertension, and white coat hypertension, compared to ambulatory blood pressure monitoring. The study will involve participants tolerating both home and ambulatory blood pressure assessments over a 24-hour period. The findings could enhance understanding of blood pressure management in children and adolescents.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 6 to less than 19 years with elevated blood pressure who can tolerate both home and ambulatory blood pressure monitoring.

Not a fit: Patients currently on antihypertensive medications or with structural heart disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of blood pressure assessments in pediatric patients, leading to better-targeted treatments.

How similar studies have performed: Other studies have shown success in using home and ambulatory blood pressure monitoring, indicating that this approach is promising.

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;

Where this trial is running

Cincinnati, Ohio

• Cincinnati Children's Hospital — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Elaine Urbina — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Mary Banks

Conditions Elevated Blood Pressure