Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF)

Zannad, F., McMurray, J.J.V. , Drexler, H., Krum, H., van Veldhuisen, D. J., Swedberg, K., Shi, H., Vincent, J. and Pitt, B. (2010) Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF). European Journal of Heart Failure, 12(6), pp. 617-622. (doi:10.1093/eurjhf/hfq049)

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Abstract

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. Approximately 3100 patients with ejection fraction < 30% and estimated glomerular filtration rate >= 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. The study will be complete when approximately 813 subjects experience a primary endpoint. Clinical Trials.gov. NCT00232180

Item Type:Articles
Keywords:acute myocardial infarction AGENTS ALDOSTERONE Aldosterone antagonist Angiotensin receptor blocker AREA IN-CHF ASSOCIATION beta-Blocker Chronic Clinical trial CLINICAL-IMPLICATIONS CONVERTING ENZYME-INHIBITOR DEATH DESIGN DOUBLE-BLIND DYSFUNCTION EFFICACY EJECTION FRACTION ENGLAND Eplerenone EXPERIENCE FAILURE GLOMERULAR-FILTRATION-RATE HEART Heart failure HEART-FAILURE hypertension INFARCTION LEFT-VENTRICULAR DYSFUNCTION MORBIDITY MORTALITY Myocardial infarction MYOCARDIAL-INFARCTION outcome OUTCOMES PATIENT patients RATIONALE SERUM SURVIVAL SYMPTOMS SYSTEM Systolic heart failure THERAPIES THERAPY TRIAL
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Zannad, F., McMurray, J.J.V., Drexler, H., Krum, H., van Veldhuisen, D. J., Swedberg, K., Shi, H., Vincent, J., and Pitt, B.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences
Journal Name:European Journal of Heart Failure
ISSN:1388-9842

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