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临床试验/NCT05612906
NCT05612906招募中不适用

Effect of RDN on Renal Function

Zhengrong Huang1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Changes of serum creatinine and urea nitrogen before and after RDN operation

研究概览

简要总结

Current studies have found the efficacy of RDN in the treatment of hypertension, however, the safety of RDN in renal function is still lacking. Therefore, the investigators are aimed to study the effect of RDN on renal function.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.18<age≤75 years; 2.clinic blood pressure ≥ 140/90 mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥ 135/85 mmHg after taking 3 or more antihypertensive drugs for more than 4 weeks; 3.essential hypertension, renal parenchymal hypertension, or hypertension patients who are willing to receive RDN ; 4.who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.

排除标准

  • pregnant women or lactating patients;
  • identified secondary hypertension or Pseudo hypertension;
  • whose renal arteries were unsuitable for ablation
  • obvious bleeding tendency and blood system diseases;
  • malignant tumors or end-stage diseases; ⑥Severe peripheral vascular disease, abdominal aortic aneurysm; ⑦A history of the acute coronary syndrome within two weeks; ⑧acute or severe systemic infection; ⑨drug or alcohol dependence or refusal to sign informed consent.

结局指标

主要结局

Changes of serum creatinine and urea nitrogen before and after RDN operation

时间窗: Baseline,1week/1 month/6months after RDN operation

Serum creatinine(umol/L, ammonia iminohydrolase assay)and urea nitrogen(umol/L, urease methods) were obtained by blood test.

Changes of glomerular filtration rate before and after RDN operation

时间窗: Baseline, 6months after RDN operation

Glomerular filtration rate(ml/min) were obtained by ECT

次要结局

  • Effect of RDN operation on renal artery(Baseline, 6months after RDN operation)
  • Urinary protein/serum creatinine ratio change before and after RDN operation(Baseline,1week/1 month/6months after RDN operation)

研究者

发起方
Zhengrong Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhengrong Huang

Professor

The First Affiliated Hospital of Xiamen University

研究点 (1)

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