Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Primary endpoint
研究概览
简要总结
Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed arterial hypertension with systolic or diastolic blood pressure >140/90 mmHg in standardized office blood pressure measurement
- •Treatment with 3 to ≤5 antihypertensive drug classes
- •Age >18 years
- •Written informed consent
排除标准
- •Age ≤ 18 years
- •anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
- •patients under legal supervision or guardianship
- •participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.
研究组 & 干预措施
Renal sympathetic denervation
All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist.
干预措施: Renal sympathetic denervation (Procedure)
结局指标
主要结局
Primary endpoint
时间窗: target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Difference in time in blood pressure target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
次要结局
- Secondary endpoints(up to 12 months)
- Secondary endpoints(months 7 to 9)
- Secondary endpoints(one week before renal denervation vs. 6 months after renal denervation)