Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05297708

Office, Home, and Ambulatory Blood Pressure

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

6 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Elaine Urbina

CONTACT

[email protected]

513-636-8265

Elaine Urbina

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6 years to <19 years old;
  • 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;
  • Tolerate ABPM 24 hours;
  • Tolerate HBP; and
  • Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.
  • On stable doses of medications known to affect BP such as:
  • Corticosteroids
  • Calcineurin inhibitors
  • Oral decongestants;
  • Clinically stable

Exclusion criteria

  • On antihypertension medications or treated in the last 6 months;
  • Pregnant;
  • Structural heart disease such as:
  • Obstructive valvular disease
  • Coarctation of the aorta
  • Cardiomyopathy;
  • Other secondary causes such as:
  • Renal artery stenosis
  • Neurological condition with dysautonomia;
  • Recent initiation of medications known to affect BP such as:
  • Corticosteroids
  • Calcineurin inhibitors
  • Oral decongestants;

Treatment and study plan

Primary outcomes

  1. Determine blood pressure phenotype

    Time frame: 6-12 months after enrollment

    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.

Secondary outcomes

  1. HBP correlation with end organ damage

    Time frame: 6-12 months after enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Banks

CONTACT

[email protected]

15136362147

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Acronym: HBPA

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 28, 2022
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.