Renal Denervation in Patients With Resistant Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Mean diurnal systolic blood pressure assessed by ABPM
研究概览
简要总结
The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
详细描述
The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the efficacy and cost-effectiveness of renal denervation plus standardized optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment alone in patients with proven resistant hypertension. Patients with essential resistant hypertension will first enter a 4-week run-in period during which they will receive a standardized triple combination therapy (diuretic+ ACE inhibitor+ CCB at maximal dose). After 4 weeks of standardized triple therapy patients will be randomized to renal denervation + optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment if daytime ambulatory BP remains ≥ 135 and/or 85 mmHg. Bilateral renal denervation will be performed using the Symplicity Catheter (Medtronic ®) - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. Study amendment: Extended follow-up of 48 months for all randomized patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is more than 18 and less than 75 years old at time of randomization
- •Essential hypertension diagnosed during a complete work-up within the past 2 years
- •Office blood pressure ≥140 and/or 90 mmHg despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, including a diuretic
- •2 functional kidneys sizing ≥ 90 mm; eGFR ≥ 40 mL/min/1.73m² (MDRD formula)
- •Suitable renal anatomy compatible with the endovascular denervation procedure
- •Signed Informed consent
- •Confirmed resistant hypertension defined by diurnal ambulatory blood pressure measurement ≥ 135 and/or 85 mmHg after 4 week standardized triple antihypertensive treatment
排除标准
- •Patients with an estimated glomerular filtration rate (eGFR) of less than 40 mL/min/1.73 m2
- •Patients with secondary hypertension
- •Kaliemia ≥ 6mmol/L
- •Patient with single functioning kidney
- •Patient with contrast media allergy
- •Patient with any implantable device incompatible with radiofrequency energy delivery
- •Patient with contra-indication to the anti-hypertensive standardized medication regimen
- •Patient with transient or fixed cerebral ischemia within 3 months before inclusion
- •Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
- •Patient with type 1 diabetes mellitus
- •Patient with malignancy within the 5 past years
- •Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm
研究组 & 干预措施
Renal denervation
干预措施: renal denervation and optimized medication regimen (Procedure)
optimized medication regimen
optimized medication regimen
干预措施: optimized medication regimen (Procedure)
结局指标
主要结局
Mean diurnal systolic blood pressure assessed by ABPM
时间窗: Baseline to 6 months
Cost-effectiveness evaluation
时间窗: 1 year
次要结局
- Adverse events of renal denervation(baseline to 48 months)
- Detailed analysis of blood pressure(baseline to 15 months)
- Change in average 24-hour and nighttime Systolic Blood Pressure by ambulatory blood pressure monitoring(baseline to 15 months)
- Antihypertensive medication score(baseline to 15 months)
- Change in average 24-hour, daytime and nighttime diastolic Blood Pressure, pulse pressure and heart rate by ambulatory blood pressure monitoring(baseline to 15 months)
- Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring(baseline to 15 months)
- Change in office Systolic/diastolic Blood Pressure(baseline to 15 months)
- Adherence to antihypertensive Medication(baseline to 15 months)