Protection of the heart with aldosterone antagonism in end-stage renal disease (PHASE 2) Trial

Forty percent of patients that require dialysis for kidney failure die within three years mostly due to heart disease. Spironlactone is a drug that is very effective at reducing heart related deaths and hospitalizations in patients with heart failure that do not also have kidney failure. It does this by reducing scarring of the heart. Kidney failure appears to trigger progressive changes in the heart that also lead to heart scarring and heart failure which, in turn, is a major cause of heart related deaths. It therefore makes sense that spironolactone would work in patients with kidney failure. However, there are no studies to tell us if spironolactone will benefit patients with kidney failure and as a result, only 1% of kidney failure patients receive spironolactone or spironolactone-like drugs. It is important to determine if spironolactone has benefits for patients with kidney failure because, if it does, there is an opportunity to reduce heart related deaths and hospitalizations. We will perform a large study in several countries that will give physicians and patients the information they need to determine if spironolactone reduces heart related deaths and hospitalizations. We call this study the Protection of the Heart with Aldosterone antagoniSm Evaluation (PHASE) trial.