Rationale and design of the eplerenone in mild patients hospitalization and survival study in heart failure (EMPHASIS-HF)

Approximately 3100 patients with ejection fraction =30 and estimated glomerular filtration rate =30 mL/min/1.73 m2 will be recruited. Patients are randomized 1:1 to double-blind eplerenone or placebo in addition to standard chronic HF therapy. Doses are adjusted from 25 mg every other day to 50 mg daily, depending on serum potassium. The primary endpoint is a composite of time to cardiovascular death or first hospital admission for worsening HF, whichever occurs first.