NCT02804087终止不适用
CALM-START - Controlling And Lowering Blood Pressure With the MobiusHDTM Device: STudying Effects in A Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 8
- 主要终点
- The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.
研究概览
简要总结
To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.
详细描述
This is a prospective, randomized, double-blind, sham-controlled, multi-center post market study investigating the efficacy and safety of MobiusHD System, and the efficacy of the MobiusHD device in lowering mean systolic 24-hour ABP in subjects with resistant hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years;
- •Diagnosed with resistant hypertension;
- •A mean systolic 24-hour ABP of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).
- •A mean systolic 24-hour ABP of 135-170 mmHg after washout of all antihypertensive medications.
排除标准
- •Known or clinically suspected baroreflex failure or autonomic neuropathy
- •Treatable cause of resistant hypertension
- •Hypertension secondary to an identifiable and treatable cause other than sleep apnea
结局指标
主要结局
The change in mean systolic 24-hour ABP from baseline to 90 days post-randomization, between the treatment arm and the sham arm.
时间窗: From Baseline to 90 days post-randomization
Reduction in mean systolic 24-hour ABP
次要结局
- Major adverse clinical events, including death, stroke, carotid interventions, and myocardial infarction, from baseline to 30 days post-randomization, between the treatment arm and the sham arm.(From Baseline to 30 days post-randomization)
研究者
研究点 (8)
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