Mechanisms of Refractory Hypertension (Carvedilol)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- % of subjects who achieve BP control (<140/90 mm Hg)
研究概览
简要总结
The purpose of this protocol is test whether patients with hypertension refractory to antihypertensive treatment have evidence of excessive sympathetic (i.e., nervous system) activity.
详细描述
Refractory hypertension refers to high blood pressure that is failing conventional antihypertensive therapies. In a retrospective assessment of such patients in our clinic we observed that resting clinic heart rates were higher in patients with refractory hypertension compared to patients with controlled hypertension. This observation has led to the hypothesis that refractory hypertension is caused by excessive sympathetic output. This protocol is designed to test this hypothesis by comparing the BP response to carvedilol verses chlorthalidone in patients with refractory hypertension. If their extreme treatment resistance is neurogenic is etiology, a significantly larger BP response to carvedilol should occur compared to chlorthalidone.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncontrolled clinic BP (>140/90 mmHg)
- •Receiving 5 or more antihypertensive agents including an ACE inhibitor or ARB, calcium channel blocker, and chlorthalidone 25 mg
排除标准
- •Current use of an alpha or beta or combined alpha-beta antagonist
- •Known allergy to alpha-beta antagonists
- •CKD (eGFR <40 ml/min/m2)
- •MI, stroke or episode of CHF exacerbation within 3 months
- •Bradycardia <50 bpm; history of 2nd or 3rd degree heart block unless treated by a pacemaker
- •Pregnant or breast-feeding women
- •Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs
研究组 & 干预措施
Carvedilol
Carvedilol CR 40 mg daily in addition to their normal BP medications. Subjects will be seen in follow-up at 2-week intervals for the duration of the 8-week intervention period. If the clinic BP remains elevated (>140/90 mmHg) at any of the follow-up visits, the study medication will be titrated up to carvedilol CR 80 mg daily (subjects will take 2 of the study pills).
干预措施: Carvedilol (Drug)
Chlorthalidone
Chlorthalidone 12.5 mg daily in addition to their normal BP medications. Subjects will be seen in follow-up at 2-week intervals for the duration of the 8-week intervention period. If the clinic BP remains elevated (>140/90 mmHg) at any of the follow-up visits, the study medication will be titrated up to chlorthalidone 25 mg daily (subjects will take 2 of the study pills).
干预措施: Chlorthalidone (Drug)
结局指标
主要结局
% of subjects who achieve BP control (<140/90 mm Hg)
时间窗: 8 weeks after baseline
BP will be measured 8 weeks after starting carvedilol and after starting chlorthaidone. The percent of subjects with BP of \<140/90 mm HG in each group will be reported.
次要结局
未报告次要终点
研究者
David Calhoun
Principal Investigator
University of Alabama at Birmingham