NCT01522430Unknown3 期
DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY
Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- glomerular filtration rate
研究概览
简要总结
The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:
- reduces daytime ambulatory blood pressure,
- improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They have a mandatory > 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion,
- •A mandatory check list of secondary cause of hypertension has been excluded
- •They succeed the pill count test.
- •They have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg, respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3).
排除标准
- •Patients with an eGFR <30ml/min/m² are excluded,
- •patients with known renal atherosclerotic lesions,
- •previous procedures in the renal arteries,
- •known unsuitable anatomy for the procedure,
- •previous nephrectomy,
- •contrast agent allergy,
- •hyperthyroidia.
结局指标
主要结局
glomerular filtration rate
时间窗: 6 month
Isotopic and 24h urine sample measure of glomerular filtration rate.
Ambulatory systolic and diastolic blood pressure
时间窗: 6 month
Ambulatory systolic and diastolic blood pressure measured on 24h ABPM device
次要结局
- Baroreflex sensitivity(6 month)
- Biological markers of acute kidney injury(baseline, H2, H6, 1, 3 and 6 months)
研究者
Jean Francois Argacha
Principal Investigator
Erasme University Hospital
研究点 (2)
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