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临床试验/NCT03223272
NCT03223272已完成2 期

Mechanisms of Refractory Hypertension (Reserpine)

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2015年7月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
7
试验地点
1
主要终点
Change Ambulatory Systolic Blood Pressure

研究概览

简要总结

The study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.

详细描述

Patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone. After withdrawal from other centrally-acting agents if needed, enrolled patients will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. Twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period. All other antihypertensive medications will remain unchanged during the 4-week treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood pressure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

排除标准

  • congestive heart failure (EF 40%)
  • chronic kidney disease (GFR <40 ml/min/1.73 mm)
  • stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months
  • ongoing depression
  • active peptic ulcer disease
  • bradycardia <50 beats per minute
  • 2nd or 3rd degree heart block
  • known intolerance of reserpine
  • use of digoxin or tricycle antidepressants

研究组 & 干预措施

Reserpine

Experimental

Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks.

干预措施: Reserpine (Drug)

结局指标

主要结局

Change Ambulatory Systolic Blood Pressure

时间窗: Baseline and 8 weeks

Twenty-four hour ambulatory systolic blood pressure

次要结局

未报告次要终点

研究者

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

David Calhoun

Professor

University of Alabama at Birmingham

研究点 (1)

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