Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease (NCT03020303) | Clinical Trial Compass
CompletedPhase 3
Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease
Australia2,538 participantsStarted 2017-07-07
Plain-language summary
Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis.
Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients.
The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age
ā. ā„45 years or
ā. ā„18 with a history of diabetes
ā. On dialysis ā„ 90 days
ā. On either
ā. Hemodialysis prescribed at least 2 treatments per week or
ā. Peritoneal dialysis prescribed with at least 1 exchange daily
ā. Provides informed consent
Exclusion criteria
ā. Hyperkalemia
ā. Serum potassium \>5.8 mmol/L in the 6 weeks prior to enrollment or
ā. Serum potassium \>6.0 mmol/L during active run-in
ā. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).