Feasibility of Electrical Mapping and Stimulation of Renal Arteries in Patients Undergoing Renal Denervation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- arterial blood pressure response
研究概览
简要总结
Study design: Investigator initiated, single centre, feasibility study
Main objectives are twofold:
- To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
- To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.
Study population: 40 patients (18 - 80 yr old)
详细描述
Background: Approximately 10-15% of adults with hypertension are considered to be treatment resistant because their hypertension is uncontrolled despite taking three or more drugs that includes a diuretic. Renal denervation (RDN) is a novel treatment option for therapy resistant hypertension and its rationale originates in denervating the renal sympathetic efferent and afferent coupling with the central autonomic nervous system. By denervating the renal arteries, general sympathetic tone is reduced. Currently, RDN is performed by placing in a spiral pattern 5-6 ablation lesions in each renal artery. 15-30% of the patients do not have any benefit from this procedure. The reason for this is unknown. Experimental data show that renal nerve stimulation (RNS) may serve as a functional endpoint to assess completeness of the RDN procedure. A RNS-guided RDN may prove to be superior to standard RDN (RNS-checked) in blood pressure control.
Main objectives are twofold:
- To investigate the feasibility of RNS in patients with therapy resistant hypertension, which is assessing the functional distribution of renal nerves using 3D imaging and differential pacing modalities.
- To investigate the blood pressure responses and cardiac excitable properties to RNS, and subsequently perform a RDN procedure, guided by 3D mapping by two different techniques e.g. RNS-checked RDN and RNS-guided RDN procedures.
Secondary objective:
The secondary objective is to compare both techniques (RNS-checked vs. RNS-guided) in terms of efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
RNS guided RDN
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
- •The patient is willing and able to comply with the protocol and has provided written informed consent.
- •Age 18-80 years
- •The patient has hypertension and is accepted for renal denervation or combined pulmonary bein isolation and renal denervation
- •Glomerular filtration rate >45 mL/min
- •No history of renal artery stenosis
排除标准
- •Type 1 diabetes mellitus
- •Contraindication to chronic anticoagulation therapy or heparin.
- •Chronic oxygen use
- •Primary pulmonary hypertension
- •Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age.
- •Known secondary cause of hypertension
- •Mental or physical inability to participate in the study.
- •Renal artery stenosis >50% of the arterial lumen, or renal artery lumen ≤3 mm.
- •Dual or triple ipsilateral renal artery ostia.
结局指标
主要结局
arterial blood pressure response
时间窗: during procedure
Main study parameter will be the arterial blood pressure response to RNS prior to renal denervation and absence of blood pressure rise in response to pacing in the renal artery after RDN.
次要结局
- blood pressure at 6 months(6 months after the intervention)
- blood pressure at 3 months(3 months after the intervention)
- blood pressure at 12 months(12 months after the intervention)
- change in blood pressure compared to measurement before the intervention(intervention - up to 12 months after the intervention)