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Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF).
Copyright policy )Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF).
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.
- University of Michigan–Ann Arbor United States
- University of Gothenburg Sweden
- Monash University Australia
- Inserm France
- Pfizer (United States) United States
Microsoft Academic Graph classification: Ejection fraction Beta blocker medicine.drug_class medicine Eplerenone medicine.drug Survival analysis Clinical endpoint Cardiology medicine.medical_specialty Myocardial infarction medicine.disease Internal medicine Heart failure business.industry business Placebo
Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, Chronic Disease, Double-Blind Method, Eplerenone, Heart Failure, Systolic, Hospitalization, Humans, Mineralocorticoid Receptor Antagonists, Research Design, Spironolactone, Survival Analysis, Systolic heart failure, Clinical trial, Outcome, Aldosterone antagonist, LEFT-VENTRICULAR DYSFUNCTION, ANGIOTENSIN RECEPTOR BLOCKER, CONVERTING ENZYME-INHIBITOR, AREA IN-CHF, MYOCARDIAL-INFARCTION, CLINICAL-IMPLICATIONS, BETA-BLOCKER, ALDOSTERONE, MORTALITY, TRIAL, Cardiology and Cardiovascular Medicine
Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, Chronic Disease, Double-Blind Method, Eplerenone, Heart Failure, Systolic, Hospitalization, Humans, Mineralocorticoid Receptor Antagonists, Research Design, Spironolactone, Survival Analysis, Systolic heart failure, Clinical trial, Outcome, Aldosterone antagonist, LEFT-VENTRICULAR DYSFUNCTION, ANGIOTENSIN RECEPTOR BLOCKER, CONVERTING ENZYME-INHIBITOR, AREA IN-CHF, MYOCARDIAL-INFARCTION, CLINICAL-IMPLICATIONS, BETA-BLOCKER, ALDOSTERONE, MORTALITY, TRIAL, Cardiology and Cardiovascular Medicine
Microsoft Academic Graph classification: Ejection fraction Beta blocker medicine.drug_class medicine Eplerenone medicine.drug Survival analysis Clinical endpoint Cardiology medicine.medical_specialty Myocardial infarction medicine.disease Internal medicine Heart failure business.industry business Placebo
citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).66 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).66 popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.Average influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).Average impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.Average
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- University of Michigan–Ann Arbor United States
- University of Gothenburg Sweden
- Monash University Australia
- Inserm France
- Pfizer (United States) United States
- University of Glasgow United Kingdom
- Hannover Medical School Germany
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.