Office, Home, and Ambulatory Blood Pressure
Recruiting · NCT05297708 · Observational (researchers observe without assigning treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
6 Years to 19 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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;
Where it is running
1 location listed across 1 US state.
- Cincinnati Children's Hospital - Cincinnati, Ohio, United States