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Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF)
Copyright policy )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 fractionor =30% and estimated glomerular filtration rateor =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.
Microsoft Academic Graph classification: Ejection fraction Internal medicine medicine.medical_specialty medicine business.industry business Beta blocker medicine.drug_class Eplerenone medicine.drug Survival analysis Heart failure medicine.disease Cardiology Placebo Myocardial infarction Clinical endpoint
Systolic heart failure, Clinical trial, Outcome, Aldosterone antagonist, Eplerenone, LEFT-VENTRICULAR DYSFUNCTION, ANGIOTENSIN RECEPTOR BLOCKER, CONVERTING ENZYME-INHIBITOR, AREA IN-CHF, MYOCARDIAL-INFARCTION, CLINICAL-IMPLICATIONS, BETA-BLOCKER, ALDOSTERONE, MORTALITY, TRIAL, Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, Chronic Disease, Double-Blind Method, Heart Failure, Systolic, Hospitalization, Humans, Mineralocorticoid Receptor Antagonists, Research Design, Spironolactone, Survival Analysis, Cardiology and Cardiovascular Medicine
Systolic heart failure, Clinical trial, Outcome, Aldosterone antagonist, Eplerenone, LEFT-VENTRICULAR DYSFUNCTION, ANGIOTENSIN RECEPTOR BLOCKER, CONVERTING ENZYME-INHIBITOR, AREA IN-CHF, MYOCARDIAL-INFARCTION, CLINICAL-IMPLICATIONS, BETA-BLOCKER, ALDOSTERONE, MORTALITY, TRIAL, Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, Chronic Disease, Double-Blind Method, Heart Failure, Systolic, Hospitalization, Humans, Mineralocorticoid Receptor Antagonists, Research Design, Spironolactone, Survival Analysis, Cardiology and Cardiovascular Medicine
Microsoft Academic Graph classification: Ejection fraction Internal medicine medicine.medical_specialty medicine business.industry business Beta blocker medicine.drug_class Eplerenone medicine.drug Survival analysis Heart failure medicine.disease Cardiology Placebo Myocardial infarction Clinical endpoint
- Inserm France
- Monash University Australia
- University of Michigan–Flint United States
- Pfizer (United States) United States
- Hannover Medical School Germany
- Inserm France
- Monash University Australia
- University of Michigan–Flint United States
- Pfizer (United States) United States
- Hannover Medical School Germany
- University of Gothenburg Sweden
- University of Glasgow United Kingdom
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 fractionor =30% and estimated glomerular filtration rateor =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.