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Clinical Trials/NCT05297708
NCT05297708
Active, not recruiting
Not Applicable

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

Children's Hospital Medical Center, Cincinnati1 site in 1 country52 target enrollmentMarch 24, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elevated Blood Pressure
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
52
Locations
1
Primary Endpoint
Determine blood pressure phenotype
Status
Active, not recruiting
Last Updated
10 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2022
End Date
September 1, 2026
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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;
  • 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

Outcomes

Primary Outcomes

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

  • HBP correlation with end organ damage(6-12 months after enrollment)

Study Sites (1)

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