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临床试验/NCT02121041
NCT02121041已完成不适用

Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

Anthony J Viera, MD, MPH1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
24 Hour Blood Pressure Average at the End of 4 Month Participation.

研究概览

简要总结

The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.

详细描述

The usual strategy for detecting hypertension-repeated office blood pressure (BP) measurements-is inefficient and inaccurate. When paired with ambulatory BP monitoring (ABPM), which takes a multitude of measurements over 24 hours, it is clear that office BP measurements may convey a falsely positive diagnosis known as white-coat hypertension. What is less well-known is that office BP measurements may also convey a falsely negative diagnosis termed masked hypertension (MH). That is, office BP may measure as normal, yet 24-hour ambulatory measurements show elevated BP. People with MH have cardiovascular risk that is similar to that of people with diagnosed hypertension, yet MH goes unrecognized, and therefore, untreated. Ultimately, identifying the best strategy for accurately detecting hypertension is vital to improving overall BP control and reducing cardiovascular events. Without a feasible ABPM strategy, MH will continue to go unrecognized and untreated.

Participants enrolled in the study will be randomized to either the usual care group or the ABPM-guided group. All participants will have a baseline ABPM. ABPM will be used to make a diagnosis and determine anti-hypertensive treatment in the ABPM-guided group only. Participants in the ABPM-guided group will have a follow-up ABPM in 2 months. All participants will have a final ABPM 4 months after enrollment.

研究设计

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

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 30 years and ≤ 65 years
  • Most recent (within 14 days) clinic systolic BP 126-150 mm Hg
  • Able/willing to wear a BP monitor for 24 hours on multiple occasions
  • Able/willing to take daily anti-hypertensive medication if indicated
  • Able to read and speak English

排除标准

  • Pregnant or trying to become pregnant
  • Known heart disease
  • History of persistent atrial fibrillation
  • Currently taking antihypertensive medication
  • Currently taking Simvastatin > 20mg daily
  • Clinician recommends against participation

研究组 & 干预措施

ABPM Guided

Active Comparator

Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.

干预措施: Amlodipine (Drug)

ABPM Guided

Active Comparator

Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.

干预措施: Chlorthalidone (Drug)

ABPM Guided

Active Comparator

Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.

干预措施: Losartan (Drug)

结局指标

主要结局

24 Hour Blood Pressure Average at the End of 4 Month Participation.

时间窗: Participants will be on study average of 4 months.

次要结局

未报告次要终点

研究者

发起方
Anthony J Viera, MD, MPH
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anthony J Viera, MD, MPH

Distinguished Associate Professor, Family Medicine

University of North Carolina, Chapel Hill

研究点 (1)

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