Status:
ACTIVE_NOT_RECRUITING
Office, Home, and Ambulatory Blood Pressure
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Elevated Blood Pressure
Eligibility:
All Genders
6-19 years
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 press...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05297708
Start Date
March 24 2022
End Date
September 1 2026
Last Update
June 19 2025
Active Locations (1)
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1
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229