Home BP Monitoring

High Blood Pressure Clinical Trial

Official title:

Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552547
• Other study ID #: STUDY20221105
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 21, 2025

Study information

• Verified date: February 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: Goutham Rao, MD
• Phone: (216)844-3791
• Email: goutham.rao[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most cases of high blood pressure in teens are missed for a number of reasons. One reason is that the most common way to make a diagnosis is to make three or more blood pressure measurements in a doctor's office on separate days. This can be inconvenient. Also, measuring blood pressure in the office might be inaccurate, since children (including teens) might have high values in the office but normal values at home. For these reasons, investigators wish to study a different way to identify teens with high blood pressure. Home BP measurements have been used in Europe to make a diagnosis, but not yet in the United States, and never in a higher risk population of teens. African American teens are at higher risk for high blood pressure than other teens. Investigators will compare the values received from the home BP machines to another method (24 hour ambulatory BP monitoring or ABPM) which is the best standard for diagnosis. Investigators also want to learn more about participants experience and their child's experience with both methods. A small sample of participating teens and parents will be invited to participate in short telephone interviews. This study plans to enroll a total of 750 teens at UH. Recruitment will not take place from other organizations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: October 21, 2025
• Est. primary completion date: October 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Self-identify or identified by a parent as African-American or of partly African American ancestry

Exclusion Criteria:

• Prior hypertension diagnosis

• Prescribed BP medication

• History of congenital heart disease

• History of solid organ transplant

• Prescribed and using stimulants and other medications on a regular basis known to raise blood pressure such as testosterone and nicotine replacement

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Device:
• Home Blood Pressure Machine
Participants will be asked to measure blood pressure twice daily for three days in a row at home.
• 24-Hour Blood Pressure Machine
Participants will be asked to wear the machine for 24 hours.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Goutham Rao, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who meet criteria for hypertension based on average home BP reading.		Up to 2 weeks
Primary	Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.		Up to 24 hours
Primary	Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM		Up to 2 weeks
Primary	True positive rate -- Number of home bp positives over ABPM positives		Up to 2 weeks
Primary	True negative rate -- Number of home bp negatives over ABPM negatives		Up to 2 weeks
Secondary	Number of subjects who complete home BP protocol		Up to 2 weeks
Secondary	Number of subjects who complete both home BP verus 24-hour ABPM protocols		Up to 3 weeks