Renal Sympathetic Denervation for Treatment Resistant Hypertension and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors (The Re-Shape CV-Risk Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in blood pressure
研究概览
简要总结
The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys, which in the "Symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11 mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have beneficial effects not only on blood pressure, but also on insulin sensitivity and hyperinsulinaemia.
The investigators aim to introduce RDN as a clinical study where blood pressure reduction and methodical, technical aspects will be evaluated, but more importantly, also additional effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness, fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and sub-clinical organ damage.
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 Years.
- •Resistant hypertension, as defined in the 2007 ESH-ESC guidelines and confirmed by ambulatory or home blood pressure measurements. (Here office BP > 140/90 mmHg on 4 or more antihypertensive drugs in adequate dosages (including one diuretic) or certified drug intolerance).
- •No known secondary reason for hypertension
- •Negative pregnancy test (preferably blood hCG) for female patients of childbearing potential
- •Estimated GFR (glomerular filtration rate) > 45 mL/min/1.73m².
- •Willing and able to comply with follow-up requirements
- •Signed informed consent
排除标准
- •Type 1 and type 2 diabetes
- •Pregnancy
- •Allergy to the contrast medium used during RDN and Iohexol clearance.
- •Age > 68 years
- •Hemodynamically significant heart valve disease
- •Pacemaker or ICD
- •Medication that may interfere with the procedure (Anticoagulation, Platelet inhibitors, Steroids), if they cannot be temporarily reduced or stopped.
- •Patients with transplanted kidneys
- •Reno vascular conditions like diameter < 4mm, renal artery stenosis or significant atherosclerosis, previous renal artery stenting
结局指标
主要结局
Change in blood pressure
时间窗: from baseline to two years
Change in blood pressure from baseline to two years after the intervention
次要结局
- Change in quality of Life(From baseline to two years)
- Effect of RDN on subclinical organ injury: Myocardium(from baseline to two years)
- Changes in glucose production and insulin sensitivity(from baseline to two years)
- Effect of RDN on subclinical organ injury: Endothelial function(from baseline to two years)
- Effect of RDN on subclinical organ injury: Impedance cardiography(from baseline to six months)
- Effect of RDN on subclinical organ injury: Retinal vessels(from baseline to two years)
- Effect of RDN on subclinical organ injury: Kidneys(from baseline to two years)