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

Not Applicable

Completed

• Conditions: Topic: Cardiovascular, Renal and Urogenital; Subtopic: Cardiovascular (all Subtopics), Renal and Urogenital (all Subtopics); Disease: Cardiovascular, Renal; Circulatory System

• Registration Number: ISRCTN94696478
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28888268/ protocol (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-16
• Study Completion: 2019-06-30
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified