ISRCTN94696478已完成未知
A randomised multicentre open label blinded end point trial to compare the effects of spironolactone to chlortalidone on left ventricular mass in stage 2 and stage 3 chronic kidney disease
niversity of Birmingham (UK)0 个研究点目标入组 154 人开始时间: 2014年1月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 154
研究概览
简要总结
2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28888268/ protocol (added 17/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 13/02/2018:
- •1. Aged over 18 years
- •2. Willingness to undertake all procedural investigations
- •3. Patients with either stage 2 or stage 3 CKD (eGFR by 4 MDRD equation of 30-89 ml/min/1.732, from blood tests performed within the last 12 months, on 2 occasions, at least 90 days apart)
- •4. Controlled blood pressure. The local PI must be satisfied that BP control will be clinically satisfactory during the 46 week study period
- •5. On established (>6 weeks) treatment with ACE inhibitors or ARBs
- •6. Clinically stable (no hospital admission or significant acute illness within 3 months and no recent (<6 months) acute myocardial infarction or symptoms, or other evidence, of heart failure and/or left ventricular dysfunction)
- •7. Written informed consent
- •Previous inclusion criteria:
- •1. Aged over 18 years
- •2. Diagnosis of stage 3 CKD [estimated glomerular filtration rate (eGFR) by 4 variable Modification of Diet in Renal Disease (MDRD) of 3059ml/min/1.73m2 on 2 occasions, at least 3 months apart]
- •3. Well controlled blood pressure (office reading of <150/90 mmHg, i.e. within 10 mmHg of the systolic level recommended in the Renal Association Clinical Practice Guideline, Fifth edition)
- •4. On established (>6 weeks) treatment with angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)
- •5. Written informed consent
排除标准
- •Current exclusion criteria as of 13/02/2018:
- •1. Diabetes mellitus
- •2. Clinical evidence of hypovolaemia
- •3. On current regular treatment with non-steroidal anti-inflammatory drugs, or other agents (except ACEi, ARB or low-dose aspirin) that might cause a reduction in GFR.
- •4. Recent (<6 months) acute myocardial infarction or other major adverse cardiovascular event
- •5. Known left ventricular systolic dysfunction or severe valvular disease
- •6. Active malignant disease with a life expectancy of <5 years
- •7. Previous hyperkalaemia (K+ =6.0 mmol/l without precipitating cause)
- •8. Serum K+ =5.0 mmol/l at entry
- •9. Serum sodium <130 mmol/l at entry
- •10. Current treatment with spironolactone or other MRB
- •11. Atrial fibrillation on screening ECG
- •12. Use of a thiazide or loop diuretic in the 6 weeks prior to enrolment
- •13. Pregnant or breast feeding
- •14. Known alcohol or drug abuse
- •15. Active chronic diarrhoea
- •16. Recent active gout (within 3 months)
- •17. Episode of acute kidney injury within 3 months
- •18. Documented Addisons disease
- •19. Current treatment with fludrocortisone, lithium, or cotrimoxasole
- •20. Combination treatment with ACE inhibitor and ARB
- •21. Office blood pressure <115 mmHg systolic or <50 mmHg diastolic
- •22. Office blood pressure uncontrolled and requiring urgent non trial treatment in the opinion of the clinical investigator
- •Previous exclusion criteria:
- •1. Diabetes mellitus
- •2. Clinical evidence of hypovolaemia
- •3. Recent (<6 months) acute myocardial infarction or other major adverse cardiovascular event
- •4. Established diagnosis of left ventricular dysfunction or heart failure
- •5. Active malignant disease with a life expectancy of <5 years
- •6. Previous hyperkalaemia (K+ =6.0 mmol/l without precipitating cause)
- •7. Serum K+ =5.0 mmol/l at entry
- •8. Serum sodium <132 mmol/l at entry
- •9. Atrial fibrillation on screening ECG
- •10. Use of a thiazide or loop diuretic in the 6 weeks prior to enrolment
- •11. Pregnancy
- •12. Known alcohol or drug abuse
- •13. Active chronic diarrhoeal illness
- •14. Recent active gout (within 3 months)
- •15. Episode of acute kidney injury within 3 months
- •16. Documented Addison?s disease
- •17. Current treatment with fludrocortisone or cotrimoxasole
- •18. Office blood pressure <115 mmHg systolic or <50 mmHg diastolic
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