Renal Denervation in Treatment Resistant Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- office BP
研究概览
简要总结
In patients with treatment resistant hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction.
The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation:
Short term effects:
A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation
Long term effects:
D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall properties after 6 and 12 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •treatment resistant hypertension
- •male of female aged over 18 years
- •written informed consent
- •agreement to attend all study visits as planned in the protocol
排除标准
- •chronic kidney disease 3 - 5
- •any contradictions for MRI
- •claustrophobia
- •strabismus
- •severe ocular diseases
- •history of epilepsia
结局指标
主要结局
office BP
时间窗: baseline, 6 months
change in office blood pressure from baseline to 6 months post-renal denervation
Magnetic resonance imaging (MRI)
时间窗: baseline, 3 and 6 months
* change in total sodium content measured by MRI from baseline to 6 months post-renal denervation * change in renal perfusion measured by MRI from baseline to 3 months post-renal denervation
Albuminuria
时间窗: baseline, 6 months
change in urinary albumin/creatinine ratio from baseline to 6 months post-renal denervation
Systemic RAS activity
时间窗: baseline, 6 months
* change in sodium, potassium and creatinine from baseline to 6 months post-renal denervation * change in aldosterone excretion from baseline to 6 months post-renal denervation * change in sodium/potassium ratio from baseline to 6 months post-renal denervation * change in plasma renin activity and angiotensin II concentration at least 30 minutes of rest in a supine position and immediately after standing from baseline to 6 months post-renal denervation
Local RAS activity
时间窗: baseline, 6 months
change in urinary angiotensinogen concentration from the morning spot urine from baseline to 6 months post-renal denervation
24-ABPM
时间窗: baseline, 6 months
change in 24 hour ambulatory blood pressure (ABPM) from baseline to 6 months post-renal denervation
Vascular structure and function of large and small arteries
时间窗: baseline, 6 months
* change in flow-mediated vasodilation (FMD)from baseline to 6 months post-renal denervation * change in scanning laser Doppler flowmetry (SLDF) from baseline to 6 months post-renal denervation * change in funduscopy from baseline to 6 months post-renal denervation * change in pulse wave analysis (PWA) from baseline to 6 months post-renal denervation * change in pulse wave velocity (PWV) from baseline to 6 months post-renal denervation * change in urinary albumine/creatinine ratio (UACR) of the morning spot urine sample from baseline to 6 months post-renal denervation
次要结局
- MRI(1 day and 12 months)
- Systemic RAS activity(1 day, 3 and 12 months)
- BP(3 and 12 months)
- Local RAS activity(1 day, 3 and 12 months)
- Albuminuria(3 and 12 months)
- Vascular structure and function of large and small arteries(3 and 12 months)