Office, Home, and Ambulatory Blood Pressure
ConditionElevated Blood Pressure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-19
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
On antihypertension medications or treated in the last 6 months;
Pregnant;
Obstructive valvular disease
Coarctation of the aorta
Trial population
The population will be pediatric patients 6 years to \<19 years years of age who were referred for elevated blood pressure to the Recruitment Hypertension clinic, Lipid Clinic, or Center for Better Health and Nutrition.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
52 Participants
are grouped into 1 trial groupGroup A: All Participants
Trial outcomes
Primary outcomes
1
Determine blood pressure phenotype
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.
Time frame
6-12 months after enrollmentSecondary outcomes
1
HBP correlation with end organ damage
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.
Time frame
6-12 months after enrollmentSponsors and contacts
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Source ClinicalTrials.gov