Office, Home, and Ambulatory Blood Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Elevated Blood Pressure. Basic parameters: 6 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Office, Home, and Ambulatory Blood Pressure Measurements in Pediatric Patients
Overview
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.
Primary outcome measures
- Determine blood pressure phenotype [Time frame: 6-12 months after enrollment]
Secondary outcome measures (1)
- HBP correlation with end organ damage [Time frame: 6-12 months after enrollment]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Cincinnati Children's Hospital — Cincinnati
Identifiers
NCT: NCT05297708 · 2021-0843