Spironolactone TO Prevent cardiovascular events in early stage Chronic Kidney Disease (CKD)

Not Applicable

Completed

Conditions: Chronic kidney disease, stage 1
Early Stage Chronic Kidney Disease
Urological and Genital Diseases

Registration Number: ISRCTN80658312

Lead Sponsor: niversity of Birmingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 500

Inclusion Criteria

1. Male and female, age over 18 years
2. Diagnosis of CKD stage 3

Exclusion Criteria

1. Diabetes Mellitus
2. Terminal disease or felt otherwise unsuitable by their general practitioner
3. Chronic heart failure i.e. a clinical diagnosis or known ejection fraction <55%
4. Atrial fibrillation
5. Alcohol or drug abuse
6. Inability to comply with trial medication and follow-up
7. Documented previous hyperkalaemia or intolerance of spironolactone
8. Documented Addisonian crisis and/or on fludrocortisone
9. Severe hypertension: blood pressure >= 180/110 mmHg
10. Systolic blood pressure < 120mmHg
11. Recent acute kidney injury or hospital admission (within past 6 weeks)
12. Chronic diarrhoea
13. Albumin:creatinine ratio (ACR) >= 70mg/mmol
14. Serum potassium >= 5 mEq/L on screening blood test
15. Concomittant co-trimoxazole medication
16. Concomittant angiotensin-converting enzyme inhibitor and angiotensin II receptor blocker medication
17. Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in carotid-femoral pulse wave velocity measured at baseline and 40 weeks

Secondary Outcome Measures

Name	Time	Method
1. Change in blood pressure measured at baseline and 40 weeks<br>2. Change in estimated Glomerular Filtration Rate (eGFR) measured at baseline and 40 weeks<br>3. Incidence of hyperkalaemia measured at baseline and 40 weeks<br>4. Incidence of hypotension (<100mmHg or >20mmHg systolic drop on standing) measured at baseline and 40 weeks