Rationale and design of the Eplerenone in Mild Patients Hospitalization And
SurvIval Study in Heart Failure (EMPHASIS-HF).
Author(s): Zannad F, McMurray JJ, Drexler H, Krum H, van Veldhuisen DJ, Swedberg K, Shi H,
Vincent J, Pitt B.
Affiliation(s): Inserm, Centre d'Investigation Cliniques CIC 9501 and U961, CHU and Department of
Cardiology, Nancy University, Nancy, France. f.zannad@chu-nancy.fr
Publication date & source: 2010, Eur J Heart Fail. , 12(6):617-22
AIMS: 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. CONCLUSION: The study will be complete when approximately 813
subjects experience a primary endpoint. Clinical Trials.gov. NCT00232180.
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