Patient Group: Patients who are or were on dialysis
Region: All regions
Forty percent of patients that require dialysis die within three years, mostly due to heart disease. Spironolactone is a drug that is very effective at reducing scarring of the heart and might help prevent heart-related deaths in patients with kidney failure. Heart damage can also occur from the accumulation of toxins, because dialysis does not clean blood as well as natural kidneys. However, a new dialysis filter, the Theranova, cleans more toxins from the body and so may improve heart health.
We will determine if spironolactone and the Theranova dialyzer reduce heart related deaths and hospitalizations and/or reduce some the symptoms of dialysis. We will do a large international study with over 5,000 dialysis patients in several countries. Patients will be randomly assigned to spironolactone or their usual care. Patients will also be randomly assigned to use the Theranova dialyzer or continue dialysis with their usual dialyzer. Patients will be followed for five years, and we will be able to determine how often heart failure occurs in the different groups of patients (those taking the new drug, those on the new dialyzer, those on both, those on neither). We will follow patients carefully for dialysis symptoms and health related quality of life every six months for the whole trial.