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临床试验/EUCTR2012-000654-55-GB
EUCTR2012-000654-55-GB进行中(未招募)不适用

Spironolactone to Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (CKD): A Pilot Trial - STOP-CKD

niversity of Birmingham0 个研究点目标入组 240 人开始时间: 2012年5月11日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
240

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Age over 18 years
  • 2. Diagnosis of CKD Stage 3 (eGFR 30-59 ml/min/1.73m2) using the MDRD (Modification of Diet in Renal Disease) equation.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 120
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 120

排除标准

  • Diabetes Mellitus
  • Terminal disease or felt otherwise unsuitable by their general practitioner (GP)
  • Chronic heart failure i.e. a clinical diagnosis or known ejection fraction (EF) <55%
  • Atrial fibrillation
  • Alcohol or drug abuse
  • Inability to comply with trial medication and follow-up
  • Documented previous hyperkalaemia or intolerance of spironolactone
  • Documented Addison’s disease and/or on fludrocortisone
  • Severe hypertension: blood pressure = 180/110 mmHg
  • Systolic blood pressure less than 120mmHg
  • Recent acute kidney injury or hospital admission (within past 6 weeks)
  • Chronic diarrhoea
  • ACR>70 mg/mmol (will require specialist referral if not already made)
  • Serum potassium = 5 mmol/L on screening blood test
  • Concomitant co-trimoxazole medication
  • Concomitant angiotensin-converting enzyme inhibitor AND angiotensin II receptor blocker medication

研究者

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