Evaluating blood pressure measurements in children and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mary.banks@cchmc.org
• Phone: 15136362147

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.