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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 19
View:

• 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

Locations
United States
Ohio
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Contact Information
Primary
Mary Banks
mary.banks@cchmc.org
15136362147
Time Frame
Start Date: 2022-03-24
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 52
Treatments
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.
Authors
James Reagor
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati

This content was sourced from clinicaltrials.gov