Assessment of Early GFR, Tubular Function and Pathology Changes Early and Late After Renal denervatioN
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change of a specific protein score in urine between Baseline visit (Day 1) and 12 months follow-up visit
研究概览
简要总结
The purpose of this clinical study is to better understand how renal denervation (RDN) affects kidney function, both shortly after and up to a year after the procedure. Renal denervation is a minimally invasive treatment used for patients with high blood pressure that does not respond well to medication ("resistant hypertension"). It works by reducing the activity of nerves that run along the arteries supplying the kidneys, which helps lower blood pressure.
To understand how RDN affects the kidneys, we will measure kidney function in detail and analyse blood and urine samples collected before and after the procedure. This will help researchers see whether the procedure causes changes in the kidneys, and whether some of these changes are linked to better kidney health over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •≥18 years
- •eGFR >30 ml/min/1.73m2 (CKD stages 3b and less severe)
- •Informed consent for study participation provided by the patient or the legal guardian
- •Patient information and consent to the processing of personal data
- •Stable therapy in the previous three months
- •All patients undergoing RDN for clinical indications
排除标准
- •Patients in emergency situations
- •Turbid urine sample on admission
- •Visible haematuria in the urine sample on admission
- •Pregnancy
- •Allergy to contrast media (visipaque, omnipaque, iohexol)
- •Any problem, which, in the investigator's opinion, might jeopardize the participant's compliance with the protocol.
结局指标
主要结局
Change of a specific protein score in urine between Baseline visit (Day 1) and 12 months follow-up visit
时间窗: Baseline visit (Day 1) and 12 months follow-up visit
Change of a specific protein score in urine prior to standard of care index procedure and 12 months from index procedure. Samples will be stored until the last patient had the last visit. All measurements will be then done afterwards.
次要结局
未报告次要终点