6/28/23, 9:57 PM EMPHASIS-HF Pathway Feedback Search Clinical Topics Home Studies EMPHASIS HF EMPHASIS HF Disease Heart failure Trial question What is the role of eplerenone in patients with chronic systolic HF and mild symptoms? Study design Multi-center Double blinded RCT Population Characteristics of study participants 22.0% female N = 2737 78.0% male 2737 patients (610 female, 2127 male) Inclusion criteria: patients with NYHA class II HF and an ejection fraction of no more than 35% Key exclusion criteria: acute myocardial infarction, NYHA class III or IV HF, serum potassium level > 5.0 mmol/L, an eGFR < 30 mL/min/1.73 m of body-surface area, or need for a potassium-sparing diuretic Interventions N=1364 eplerenone (up to 50 mg daily plus recommended therapy) N=1373 placebo (matching placebo plus recommended therapy) Primary outcome Death from cardiovascular causes or hospitalization for heart failure 25.9 25.9 % 19.4 % 18.3 https://web.pathway.md/studies/reca83x7Cz4fXJGcx 1/2 6/28/23, 9:57 PM EMPHASIS-HF Pathway 12.9 % Significant decrease 6.5 % NNT = 13 0.0 % Eplerenone Placebo Significant decrease in death from cardiovascular causes or hospitalization for HF (18.3% vs. 25.9%; HR 0.63, 95% CI 0.54 to 0.74) Secondary outcomes Significant decrease in death from any cause (12.5% vs. 15.5%; HR 0.76, 95% CI 0.62 to 0.93) Significant decrease in death due to cardiovascular causes (10.8% vs. 13.5%; HR 0.76, 95% CI 0.61 to 0.94) Significant decrease in hospitalizations for HF (12% vs. 18.4%; HR 0.58, 95% CI 0.47 to 0.7) Safety outcomes Significant differences in adverse event leading to discontinuation of study drug (13.8% vs. 16.2%, p = 0.09) and hyperkalemia > 5.5 mmol/L (11.8% vs. 7.2%,p < 0.001). Conclusion In patients with NYHA class II HF and an ejection fraction of no more than 35%, eplerenone was superior to placebo with respect to death from cardiovascular causes or hospitalization for HF. Reference Zannad F, McMurray JJ, Krum H et al. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. Open reference URL https://web.pathway.md/studies/reca83x7Cz4fXJGcx 2/2