Mechanisms of Refractory Hypertension (Reserpine)
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
- 否
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
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
David Calhoun
Professor
University of Alabama at Birmingham