NCT01762488终止3 期
Renal Denervation in Treatment Resistant Hypertension, a Double-blind Randomized Controlled Trial
Henrik Vase2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)
研究概览
简要总结
The purpose of this double-blind, randomized and sham controlled study is to investigate the blood pressure lowering effect of renal denervation by catheter based ablation in the renal arteries in patients with milder forms of treatment resistant hypertension. The effect on blood pressure will be evaluated by 24-hour ambulatory blood pressure measurements at baseline and after 3 and 6 months of follow up. Secondary endpoint evaluation comprises hemodynamic assessment by applanation tonometry and the cold pressor response.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic daytime (24 hour-ambulatory blood pressure measurement) > 135 mmHg and < 145 mmHg.
- •Stable (for at least 1 month and with no planned changes for the next 6 months) antihypertensive therapy with at least 3 antihypertensive drugs, including a diuretic.
- •Documented adherence to present antihypertensive therapy
排除标准
- •Pregnancy
- •Non compliance
- •Heart failure (NYHA Class III-IV)
- •LV ejection fraction < 50 %
- •Renal insufficiency (eGFR<30 ml/min)
- •Unstable coronary heart disease
- •Coronary intervention within 6 months
- •Myocardial infarction within 6 months
- •Claudication
- •Orthostatic syncope within 6 months
- •Secondary hypertension (except CKD)
- •Significant valvular heart disease
- •Clinically significant biochemical abnormalities (electrolytes, haemoglobin, hepatic function, thyroid)
- •Second and third degree AV block
- •Macroscopic haematuria
- •Renal artery anatomy not suitable for renal artery ablation (Stenosis, diameter < 4 mm, length < 2 cm or severe calcifications)
- •Moderate/severe obstructive sleep apnoea (AHI > 15) if CPAP treatment has not been attempted
结局指标
主要结局
Change from baseline in daytime systolic blood pressure (24-hour ambulatory blood pressure measurement)
时间窗: 6 months
次要结局
- Change from baseline in blood pressure (clinic and 24-hour ambulatory blood pressure measurement)(3 and 6 months)
- Change from baseline in central blood pressure, augmentation index and pulse wave velocity(6 months)
- Change from baseline in cold pressor response(6 months)
- Change from baseline in intensity of medical antihypertensive therapy(1, 3 and 6 months)
- Blood pressure (clinic measurement)(1, 3 and 6 months)
- Renal function (eGFR and electrolytes)(1, 3 and 6 months)
研究者
Henrik Vase
MD, PhD
Aarhus University Hospital Skejby
研究点 (2)
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