At a glance
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Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease
In Brief
A Phase 3 clinical trial evaluating Spironolactone 25Mg Tablet and Placebo Oral Tablet for Endstage Renal Disease. Completed, enrolled 2,538 participants across 141 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.
Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.