Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Heart failure and high blood pressure are common problems in patients that require dialysis and are key causes of death due to heart disease. Eplerenone is a drug that is very effective at improving heart failure and reducing blood pressure in patients that do not require dialysis. There is currently no evidence to tell physicians whether eplerenone would have similar benefits in patients that require dialysis. This evidence can only be reliably generated by performing a large scale study. Before such a study is undertaken, the investigators must determine whether eplerenone will be well tolerated and safe in patients that require dialysis. The investigators will perform an initial small trial called the Pilot trial in Hemodialysis patients undergoing Aldosterone antagoniSm with Eplerenone (PHASE) to determine if eplerenone is a well tolerated, safe medication to use in a very large, global study that will show whether or not eplerenone reduces important outcomes for patients like death from heart causes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
158
target 50 mg per day titrated down for hyperkalemia or hypotension
Placebo
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Winnipeg, Manitoba, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Unnamed facility
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
permanent discontinuation of the study medication for hyperkalemia or permanent discontinuation of the study medication for hyperkalemia or hypotension
Time frame: 13 weeks
permanent discontinuation of study drug for any reason
Time frame: 13 weeks
treatment adherence
Time frame: 13 weeks
pre-dialysis potassium
Time frame: 13 weeks
frequency of serious adverse events
Time frame: 13 weeks
frequency of hospitalizations for a vascular reason
Time frame: 13 weeks
fatal and non-fatal vascular events
Time frame: 13 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.