Efficacy of Distal Renal Denervation for Preventing Decline in Renal Function in Patients With Type 2 Diabetes Mellitus and Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in estimated glomerular filtration rate renal function (eGFR)
研究概览
简要总结
The aim of this study is to test the hypothesis that distal renal denervation (RDN) may delay or prevent the progressive decline of renal function in patients with type 2 diabetes mellitus and hypertension
详细描述
Detailed Description: Diabetes mellitus and hypertension are two major causes of chronic kidney disease (CKD) that starts as subclinical decline in renal function that silently progresses to symptomatic advanced stages associated with irreversible significant damage of the kidney structure. Recent major improvements in pharmacotherapy of hypertension and diabetes have substantially reduced the prevalence of cardiovascular complications, yet, the frequency of CKD remains largely unchanged. Renal denervation is a new minimally invasive method to create regional blockade of the renal sympathetic nerves that is currently used as non-pharmacological therapy of hypertension. The CKD is likewise mediated by overactivity of renal sympathetic system so that RDN has strong potential to prevent development or progression of CKD. The new anatomically optimized distal RDN may have additional benefit in this regard. Denervation of the distal vessels involved in tonic regulation of renal blood should cause a significant drop in renal vascular resistance and proportional increase in blood and oxygen supply to the kidney preventing/reducing chronic hypoxia of renal tissue that is major mechanism of CKD. The aim of this study is to prove the aforementioned concept. For this purpose the eligible patients with type 2 diabetes mellitus and hypertension will undergo distal renal denervation performed using dedicated radiofrequency catheter Symplicity Spyral. The changes in the kidney function and structure as well as BPs (office and ambulatory) will be assessed at baseline, 6 and 12 months post-procedure
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent of participation in the study;
- •systolic BP > 140 or diastolic BP > 90 mm Hg;
- •type 2 diabetes mellitus (glucose tolerance test > 11.0 mmol/l, HbA1c>6,5%);
排除标准
- •secondary hypertension;
- •type 1 diabetes mellitus;
- •acute renal failure;
- •traumatic kidney injury;
- •toxic kidney injury;
- •CKD G4 and G5 according to the KDIGO 2012;
- •infectious diseases requiring active antibacterial and/or antiviral therapy;
- •other severe diseases and conditions
结局指标
主要结局
Change in estimated glomerular filtration rate renal function (eGFR)
时间窗: from baseline to 12 months
eGFR calculated using CKD-EPI formula
次要结局
- Change in eGFR(from baseline 12 months)
- Change in cystatin C levels(from baseline to 6 and 12 months)
- Change in office blood pressure levels (systolic/diastolic)(from baseline to 6 months and 12 months)
- Change in 24-hour urinary albumin excretion(from baseline to 6 and 12 months)
- Change in peak linear blood flow velocity in the trunk and in segmental renal arteries(from baseline to 6 and 12 months)
- Change in ambulatory 24-hour blood pressure levels (24-h mean, daytime, nighttime; systolic/diastolic)(from baseline to 6 and 12 months)
- Change in lipocalin 2 (NGAL) levels(from baseline to 6 and 12 months)
- Prognostic significance of baseline HbA1c value with regard to change in eGFR(from baseline to 6 and 12 months)
- Change in renal resistive index in a trunk(from baseline to 6 and 12 months)
- Change in the cortical and medullary volume of the kidneys and their ratio according to MRI(from baseline to 12 months)