Office, Home, and Ambulatory Blood Pressure

Recruiting

• Conditions: Elevated Blood Pressure

• Registration Number: NCT05297708
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-17
• Study Start: 2022-03-24
• Study First Posted: 2022-03-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2026-06-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Age 6 years to <19 years old;

2. 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;

3. Tolerate ABPM 24 hours;

4. Tolerate HBP; and

5. Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.

6. On stable doses of medications known to affect BP such as:

   1. Corticosteroids
   2. Calcineurin inhibitors
   3. Oral decongestants;

7. Clinically stable

Exclusion Criteria

1. On antihypertension medications or treated in the last 6 months;

2. Pregnant;

3. Structural heart disease such as:

   1. Obstructive valvular disease
   2. Coarctation of the aorta
   3. Cardiomyopathy;

4. Other secondary causes such as:

   1. Renal artery stenosis
   2. Neurological condition with dysautonomia;

5. Recent initiation of medications known to affect BP such as:

   1. Corticosteroids
   2. Calcineurin inhibitors
   3. Oral decongestants;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine blood pressure phenotype	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 Outcome Measures

Name	Time	Method
HBP correlation with end organ damage	6-12 months after enrollment	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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States