NCT01848314已完成不适用
The Effect of Renal Denervation on Renal Flow in Humans
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in microvascular resistance
研究概览
简要总结
Many studies have studied the effect and safety of renal denervation. However, it remains unknown what the exact mechanism behind renal denervation is. It can be hypothesized that a difference in renal blood flow occurs after treatment. In the light of this ignorance, current study will investigate whether renal denervation leads to a difference in renal blood flow after treatment with renal denervation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Individual is scheduled to undergo renal denervation as standard patient care for resistant hypertension.
- •Individual is diagnosed with resistant hypertension. Secondary causes and a white coat hypertension are actively excluded.
- •Individual is ≥18 years of age.
- •Individual agrees to have all study procedures performed, and is competent and willing to provide written informed consent to participate in this clinical study.
排除标准
- •Individual is excluded from treatment with pRDN .
- •Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.
- •Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.
- •Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia or significant anaemia).
- •Individual is pregnant, nursing or planning to be pregnant.
- •Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
结局指标
主要结局
Change in microvascular resistance
时间窗: Within 30 minutes after renal denervation
次要结局
- change in average flow velocity(within 30 minutes after renal denervation)
研究者
研究点 (2)
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