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临床试验/NCT02623036
NCT02623036Unknown1 期

The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors in Resistant Hypertension

Memorial Health University Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
20
试验地点
1
主要终点
Change from baseline nighttime blood pressure

研究概览

简要总结

The purpose of this study is to use ambulatory blood pressure monitors to investigate whether enalapril is superior to lisinopril in managing nocturnal hypertension in patients with resistant hypertension currently treated with daytime angiotensin converting enzyme inhibitors.

详细描述

Resistant hypertension is defined as blood pressure > 140/90 mm Hg while adherent to three or more antihypertensive medications or < 140/90 mm Hg treated with four or more antihypertensives. Patients with resistant hypertension may be at risk for elevated nighttime blood pressure >120/70 mm Hg and "non-dipping" (night/day blood pressure > 0.9). A higher rate of cardiovascular events occur during the "morning surge" partially attributed elevated nighttime blood pressure due to increased renin angiotensin aldosterone system (RAAS) activity. Angiotensin converting enzyme inhibitors (ACEIs) suppress RAAS activity

This prospective randomized parallel-group pilot study will occur at Memorial Family Medicine. Eligible patients will undergo three study visits over a 5-8 week span. After providing written informed consent, patients will complete an initial screening visit assessing 25 hour blood pressure using ambulatory blood pressure monitors. Patients will continue the study if they are found to have a nighttime blood pressure >120/70 mm Hg. Patients continuing the study will be randomly assigned to equivalent dose lisinopril or enalapril treatment arms and their administration time will be changed to "bedtime." At the final visit, patients will complete a final ambulatory blood pressure analysis to reassess nighttime blood pressure and dipping status.

It's expected that patients with enalapril treatment will have superior nighttime blood pressure reduction compared to the lisinopril treatment group. If the expected outcome occurs, more patients in the enalapril group will meet their nighttime blood pressure goal (<120/70 mm Hg) and exhibit a "dipping pattern." Current evidence suggests that patients with normal nighttime blood pressure and dipping pattern are at a lower risk for cardiovascular morbidity and mortality.

研究设计

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

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with clinic blood pressure > 140/90 mm Hg on 3 antihypertensives or clinic blood pressure < 140/90 mm Hg on 4 antihypertensives
  • Currently treated with an angiotensin converting enzyme inhibitor

排除标准

  • Chronic kidney disease (CKD) stage 4 or worse
  • Pheochromocytoma
  • Unstable cardiovascular disease Stroke, Transient Ischemic Attack, Unstable Angina, or Myocardial infarction in the last 30 days
  • Hyperaldosteronism
  • Current pregnancy
  • Shift worker at night
  • Presenting blood pressure > 180/110 mm Hg

研究组 & 干预措施

Enalapril arm

Active Comparator

Patients randomized to this group will receive equivalent dose enalapril to their current ACEI therapy and change the administration time to bedtime.

干预措施: Equivalent dose enalapril (Drug)

Lisinopril arm

Active Comparator

Patients randomized to this group will receive equivalent dose lisinopril to their current ACEI therapy and change the administration time to bedtime.

干预措施: Equivalent dose lisinopril (Drug)

结局指标

主要结局

Change from baseline nighttime blood pressure

时间窗: Baseline and 4-6 weeks

Average blood pressure between 0000-0600.

次要结局

  • Change from baseline night to day blood pressure ratio (dipping status)(Baseline and 4-6 weeks)
  • Change from baseline 24 Hour Blood Pressure(Baseline and 4-6 weeks)

研究者

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

John Bucheit, Pharm.D.,BCACP, CDE

Principal Investigator

Memorial Health University Medical Center

研究点 (1)

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