Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial

Exclusion Criteria

• •1. Serum potassium ≥6.5 mEq/L within the 3 months prior to screening
• •2. Serum potassium level ≥6.0 mEq/L within 2 weeks prior to the baseline visit. If a potassium value is not available through routine clinical care during this 2-week period a potassium measurement will be performed as a research test.
• •3. Unscheduled dialysis for hyperkalemia within the 3 months prior to screening
• •4. Pre-dialysis systolic blood pressure \<100 mm Hg within 2 weeks prior to screening or at the baseline visit
• •5. 2 or more dialysis sessions within the month prior to screening with either 2 intra-dialytic measurements of systolic blood pressure \<80 mm Hg or muscle cramping, light-headedness, nausea or hypotension requiring infusion of saline or other intervention directed at hypotension
• •6. Current dual use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)
• •7. Current use of digoxin
• •8. Current use of spironolactone or eplerenone
• •9. Allergy to spironolactone
• •10. Inability to maintain dialysis machine blood flow ≥300 mL/min during any of the most recent 3 dialysis sessions prior to the screening visit as an indicator of vascular access dysfunction
• •11. Mitral valve repair or replacement
• •12. Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging
• •13. Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
• •14. Expected survival \<9 months
• •15. Pregnancy, anticipated pregnancy, or breastfeeding
• •16. Incarceration
• •17. Participation in another intervention study