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临床试验/NCT05552547
NCT05552547招募中不适用

Home BP Monitoring for Diagnosis of Hypertension in African American Adolescents

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
750
试验地点
2
主要终点
Number of participants who meet criteria for hypertension based on average home BP reading.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Number of participants who meet criteria for hypertension based on average home BP reading.

时间窗: Up to 2 weeks

Number of participants who meet criteria for hypertension based on 24-hour ambulatory BP reading.

时间窗: Up to 24 hours

Percent agreement between home BP-reading based diagnosis versus 24-hour ABPM

时间窗: Up to 2 weeks

True negative rate -- Number of home bp negatives over ABPM negatives

时间窗: Up to 2 weeks

True positive rate -- Number of home bp positives over ABPM positives

时间窗: Up to 2 weeks

次要结局

  • Number of subjects who complete home BP protocol(Up to 2 weeks)
  • Number of subjects who complete both home BP verus 24-hour ABPM protocols(Up to 3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Goutham Rao, MD

Chairman, Department of Family Medicine and Community Health

University Hospitals Cleveland Medical Center

研究点 (2)

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