Office, Home, and Ambulatory Blood Pressure

Elevated Blood Pressure Clinical Trial

— HBPA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05297708
• Other study ID #: 2021-0843
• Status: Recruiting
• Start date: March 24, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Mary Banks
• Phone: 15136362147
• Email: mary.banks[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 6 Years to 19 Years

Eligibility

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;

Related Conditions & MeSH terms

• Elevated Blood Pressure
• Hypertension

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6-12 months after enrollment
Secondary	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.	6-12 months after enrollment