Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF).
OBJECTIVE
In chronic heart failure (HF), aldosterone antagonists have been shown to improve survival in patients with low ejection fraction and moderate-to-severe symptoms [New York Heart Association (NYHA) classes III and IV]. Efficacy of these agents was also shown when they were administered to patients with left ventricular dysfunction and signs and symptoms of CHF early after acute myocardial infarction. It is not known whether the selective aldosterone antagonist eplerenone can improve outcomes in mildly symptomatic patients. The Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF) was designed to evaluate the effect of eplerenone on mortality and morbidity in patients with chronic systolic HF in NYHA class II. Methods Approximately 3100 patients with ejection fraction < or =30% and estimated glomerular filtration rate > or =30 mL/min/1.73 m(2) 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.


CONCLUSIONS
The study will be complete when approximately 813 subjects experience a primary endpoint. Clinical Trials.gov. NCT00232180.
Zannad
Faiez
F
Inserm, Centre d'Investigation Cliniques CIC 9501 and U961, CHU and Department of Cardiology, Nancy University, Nancy, France. f.zannad@chu-nancy.fr
McMurray
John J V
JJ
Drexler
Helmut
H
Krum
Henry
H
van Veldhuisen
Dirk J
DJ
Swedberg
Karl
K
Shi
Harry
H
Vincent
John
J
Pitt
Bertram
B
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D002908:Chronic Disease; D004311:Double-Blind Method; D000077545:Eplerenone; D054143:Heart Failure, Systolic / Q000188:drug therapy* / Q000401:mortality; D006760:Hospitalization; D006801:Humans; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D012107:Research Design; D013148:Spironolactone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016019:Survival Analysis
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone; D000077545:Eplerenone