Safety, Success Rate and Long Term Consequences of Renal Denervation in Patients With Therapy Resistant Hypertension. The Dutch National Renal Denervation Registry
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
This study is a national registry of patients treated with renal denervation (RD) in the Netherlands.
The aim of the study is to collect data on safety of the procedure, predictors of the blood pressure lowering effect, sustainability of the effect and to assess the cardiovascular event rate in patients treated with renal denervation.
This is a prospective observational study.
详细描述
Hypertension is common and one of the major risk factors for cardiovascular disease. Therefore, it is a major societal and economic health problem. A substantial proportion (20-40%) of the treated hypertensive patients has sub-optimal blood pressure control despite the use of multiple drugs. All these patients have an increased cardio-vascular risk. Furthermore, the use of multiple drugs diminishes compliance to treatment, and increases the risk of side effects. This underscores the need for new approaches for hypertension management. Elevated (renal) sympathetic nerve activity contributes importantly to the development of hypertension and subsequent vascular risk. Deliberate disruption of sympathetic nerve activity (sympatholytic therapy) leads to improvement of vascular outcome through blood pressure dependent and blood pressure independent effects. Recently, a promising novel sympatholytic approach has been introduced, i.e. catheter-based renal denervation in a small clinical trial with resistant hypertensive patients. Many clinical centres have now started to perform this procedure or are in the process to start up.
The Dutch Minister of Health has decided to allow renal denervation in patients with so called resistant hypertension, and "conditional reimbursement" is available starting Jan 1st 2013 for a maximum of 4 years. The Netherlands Organisation for Health Research and Development (ZonMw) has provided us with a grant to perform a randomized trial (SYMPATHY) to evaluate the effect on blood pressure at 6 months after intervention. Maximum follow-up in this trial will be 2 years. Important limitations of this study are, firstly that that follow-up is limited to 2 years after renal denervation. Secondly, not all patients that undergo renal denervation, will participate in the abovementioned trial. The Dutch National Renal Denervation Registry will complement the information from the trial in several aspects. These deal with safety, non-responders, and sustainability.
Objectives of the national database are to collect data that will deliver information on:
Safety:
- What are the short and long term procedural related complications?
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treated with renal denervation. The decision to perform the procedure was made by the treating physician in the participating hospitals
排除标准
- •below age of 18 years
结局指标
主要结局
Change in blood pressure
时间窗: 6 months
Change in blood pressure at 6 months
次要结局
- safety aspects (change in renal function)(5 years)
- safety aspects: long term kidney function(5 years)
- longterm consequences: CVD events(5 years)
- safety aspects: procedures complication(1 year)
- longterm consequences: kidney function(5 years)
- longterm consequences: mortality(5 years)
研究者
Michiel L. Bots
Professor of Epidemiology of Cardiovascular Disease
UMC Utrecht