Office, Home, and Ambulatory Blood Pressure

NCT05297708 | Active Not Recruiting

• 1 other identifier: 2021-0843
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Elevated Blood Pressure

Outcome Measures

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.

  6-12 months after enrollment

Secondary Outcomes (1)

• HBP correlation with end organ damage

  6-12 months after enrollment

Study Arms (1)

All Participants

he population would be pediatric patients 6 years to \<19 years of age who were referred for elevated blood pressure. At the initial clinic visit, the participant will be consented and a thorough history will be taken. An ECHO and non-invasive vascular measurements will be taken (central BP, augmentation index, pulse wave velocity). Patients will have an ambulatory blood pressure monitor (ABPM) placed and be trained to use a home blood pressure monitor (HBP) which will be sent home with them. The monitors in this study are FDA-approved and are being used as indicated. After one day at home, patients will return the ABPM via mail and continue to take measurements with the HBP for 20 days.

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elaine Urbina

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: March 24, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (1)