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临床试验/NL-OMON37896
NL-OMON37896已完成不适用

Catheterbased REnal SympatheCtomy for hypErteNsion after kidneyTranplantation - CRESCENT Trial

Academisch Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - renal graft in situ since > 6 months, measured creatinine clearance > 35 ml/min, and
  • - diuresis of the native kidneys at transplant >200 ml/day or radiological evidence of residual flow in the renal arteries indicating that they are accessible for the intervention and
  • - day time blood pressure >140/90 mmHg (assessed by 24-hours ambulatory measurement within 3 month prior to inclusion in the study, as is regularly performed in the nephrology outpatient clinic) while
  • - treated according to National Kidney Foundation Kidney Disease Quality Outcomes Quality Initiative guidelines (2004), i.e. having been advised to minimize salt intake and using >3 antihypertensive medications in maximal tolerated dose, including a diuretic. Medications and their dosages should not have been changed since the measurement.

排除标准

  • - (planned) pregnancy, lactation
  • - life expectancy < 1 year
  • - non-functioning renal allograft in situ
  • - contraindications for (relative) hypotensive episodes i.e. haemodynamically significant valvular disease, documented transient ischemic attacks or angina pectoris during relative hypotension.
  • - heart failure, NYHA class III-IV; chronic Lung Disease Gold III-IV
  • - major complications during previous radiological interventions (i.e. allergy to contrast agent, cholesterol embolism)
  • - (reno) vascular abnormalities in any part of the catheter access (including the aortic-ileac tract) route that impede the procedure of renal denervation
  • - use of vitamine K antagonists or other (non-aspirin) form of anti-coagulatory therapy with an absolute indication (i.e. that cannot be temporarily stopped)
  • - implantable cardioverter defibrillator (ICD) in situ
  • - planned surgery within the next six months.
  • - Drugs- or alcohol abuse
  • - Inability to give informed consent

研究者

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