Study of Efficacy and Safety of Radiofrequency Sympathetic Renal Denervation for Treatment of Drug Resistant Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Number of Serious Adverse Events
研究概览
简要总结
Single-center, single group study of the efficacy and safety of transcatheter renal denervation for treatment of patients with essential hypertension uncontrolled despite combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic. Bilateral transcatheter renal denervation will be performed on the top of existed pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of follow-up.
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
- •Age ≥ 18 and ≤ 80 years at time of randomization
- •Informed consent
- •Treatment with full doses of 3 or more anti-hypertensive medications of different classes, of which one is a diuretic.
- •Office Systolic BP (SBP) ≥ 160 mmHg or Diastolic BP (DBP) ≥ 100 mmHg
排除标准
- •An estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
- •Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP < 135 mmHg or DBP < 85 mmHg
- •Symptomatic(secondary) hypertension
- •Severe renal artery stenosis or renal arteries abnormalities
- •Individual is pregnant, nursing or planning to be pregnant
- •Severe hepatic dysfunction
- •Any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
结局指标
主要结局
Number of Serious Adverse Events
时间窗: from baseline to 12 months
A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.
Change in Office Systolic BP
时间窗: from baseline to 12 months
次要结局
- Change in Office Diastolic BP(from baseline to 6 month)
- Change in Mean Daytime Systolic BP(from baseline to 12 months)
- Change in Nighttime Systolic BP Variability(from baseline to 6 months)
- Change in Serum Creatinine(from baseline to 12 months)
- Change in Office Systolic BP(from baseline to 6 month)
- Change in Echocardiographic Left Ventricular Mass(from baseline to 12 months)
- Change in Mean Daytime Diastolic BP(from baseline to 12 months)
- Change in Mean 24-h Diastolic BP(from baseline to 6 months)
- Change in Nighttime Diastolic BP Variability(from baseline to 6 months)
- Change in Casual Proteinuria(from baseline to 12 months)
- Change in Mean Nighttime Systolic BP(from baseline to 12 months)
- Change in Mean Nighttime Diastolic BP(from baseline to 12 months)
- Change in Mean 24-h Systolic BP(from baseline to 6 months)
- Change in Daytime Diastolic BP Variability(from baseline to 6 months)
- Change in Mean Nighttime Systolic BP Dipping(from baseline to 12 months)
- Change in Mean Nighttime Diastolic BP Dipping(from baseline to 12 months)
- Change in Ultrasound Intima Media Thickness of Carotid Artery(from baseline to 12 months)
- Change in Arterial Stiffness(from baseline to 6 months)
- Change in Daytime Systolic BP Variability(from baseline to 6 months)
- Change in Specific Gravity of Urine(from baseline to 12 months)
- Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery(from baseline to 6 months)
- Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery(from baseline to 12 months)
- Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery(from baseline to 12 months)
- Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery(from baseline to 6 months)
- Change in Morning Surge of BP(from baseline to 6 months)
研究者
Stanislav Pekarskiy
Principal Investigator
Tomsk National Research Medical Center of the Russian Academy of Sciences