NCT02042066Unknown1 期
Efficacy and Safety of Low Intensity- Extracorporeal Shockwave Therapy in Drug Resistant Hypertension
适应症
试验速览
- 阶段
- 1 期
- 发起方
- Medispec
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Ambulatory Blood Pressure Monitoring (ABPM)
研究概览
简要总结
Low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have provided written informed consent.
- •Age ≥18 and ≤80 years old.
- •Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic (unless there is a tolerance or a contraindication for a diuretics).
- •Able and willing to comply with the required follow-up schedule.
排除标准
- •Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.
- •Have hypertension secondary to an identifiable and treatable cause or take medication that can raise the BP.
- •Prior renal artery intervention (balloon angioplasty or stenting).
- •Pregnancy.
- •Uncompensated heart failure.
- •Chronic Liver Disease.
- •Patients with skin wound / infection at the treatment area.
- •Subjects who take oral anti-coagulants.
- •Local tumor of treatment area.
结局指标
主要结局
Ambulatory Blood Pressure Monitoring (ABPM)
时间窗: 3 Months
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to three months post last treatment (± 2 weeks)
次要结局
- Office Blood Pressure(3 Months)
- Serum Urea and Creatinine(6 Months)
- Ultrasound(3 Months)
- Adverse Events(6 Months)
研究者
研究点 (2)
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