Aldosterone, a hormone that promotes sodium retention and potassium excretion, plays a significant role in the pathophysiology of heart failure by contributing to fluid overload, myocardial fibrosis, and vascular damage.
Patients were eligible for enrollment if they had recently been diagnosed with severe heart failure (NYHA class III or IV) and a left ventricular ejection fraction (LVEF) of 35% or less, who were already receiving standard therapy (ACE inhibitors, loop diuretics, and, if tolerated, digoxin).
[1][2] The trial was stopped early because the beneficial effect of spironolactone on all-cause death exceeded the prespecified discontinuation requirements.
[4][5] The RALES trial established spironolactone as a vital component of therapy for patients with severe heart failure, demonstrating significant reductions in mortality and hospitalization and improvements in symptoms.
The trial's findings have been instrumental in shaping current heart failure treatment guidelines and improving patient outcomes.