Anatomically Optimized Distal Renal Denervation for Treatment of Resistant Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
研究概览
简要总结
Objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the intervention with the treatment equally distributed within its main trunk for the treatment of drug-resistant hypertension.
详细描述
Recent spectacular failure of renal denervation (RDN) therapy in SymplicityHTN-3 trial in fact might be easily predicted from the very beginning. Conventional RDN done as 4-6 point treatments equally distributed within main trunk of renal artery (RA) may only be effective if renal plexus tightly surrounds the artery throughout its whole course with equal longitudinal and circumferential density of the nerve fibers. While this idea itself is unnaturally idealistic also a number of surgical studies demonstrated that proximally majority of renal nerves go at a distance from RA obliquely to its course and join the artery mainly in its distal part (fan-shaped renal plexus with wide base directed toward aorta and apex converging to renal gate). We developed a distal mode of RDN targeting segmental branches of RA and conducted a single-center double-blind randomized controlled parallel group study to compare its efficacy and safety to those of conventional RDN in patients with drug-resistant hypertension.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systolic BP is equal or greater than 160 mmHg or diastolic BP is equal or greater than 100 mmHg,
- •stable (>3 months) treatment with full doses of at least 3 antihypertensive drugs including a diuretic,
- •given written informed consent
排除标准
- •secondary hypertension
- •24h-mean systolic BP <135 mmHg,
- •estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2,
- •extended disease of renal artery,
- •any other clinically important disorders/comorbidities significantly increasing risk of endovascular intervention (investigator's assessment)
结局指标
主要结局
Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)
时间窗: From baseline to 6 months
次要结局
- Changes of 24h-mean Diastolic BP(From baseline to 12 months)
- Number of Adverse Events(From baseline to 12 months)
- Changes of 24h-mean Systolic BP(From baseline to 12 months)
- Changes of Daytime Systolic BP(From baseline to 6 months)
- Changes of Daytime Mean Systolic BP(From baseline to 12 months)
- Changes of Nighttime Mean Diastolic BP(From baseline to 12 months)
- Changes of Estimated Glomerular Filtration Rate (eGFR)(From baseline to 12 months)
- Changes of Office Diastolic BP(From baseline to 12 months)
- Changes of Nighttime Mean Systolic BP(From baseline to 12 months)
- Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries(From baseline to 6 months)
- Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries(From baseline to 6 months)
- Changes of Serum Creatinine(From baseline to 12 months)
- Changes of Office Systolic BP(From baseline to 12 months)
- Changes of Daytime Mean Diastolic BP(From baseline to 12 months)
研究者
Stanislav Pekarskiy
Principal Investigator
Tomsk National Research Medical Center of the Russian Academy of Sciences