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临床试验/NCT05297708
NCT05297708招募中不适用

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

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年3月24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
52
试验地点
2
主要终点
Determine blood pressure phenotype

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
6 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • On antihypertension medications or treated in the last 6 months;
  • 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;

结局指标

主要结局

Determine blood pressure phenotype

时间窗: 6-12 months after enrollment

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.

次要结局

  • HBP correlation with end organ damage(6-12 months after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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