PMID- 20388647
OWN - NLM
STAT- MEDLINE
DCOM- 20100820
LR  - 20181201
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 12
IP  - 6
DP  - 2010 Jun
TI  - Rationale and design of the Eplerenone in Mild Patients Hospitalization And 
      SurvIval Study in Heart Failure (EMPHASIS-HF).
PG  - 617-22
LID - 10.1093/eurjhf/hfq049 [doi]
AB  - 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.
FAU - Zannad, Faiez
AU  - Zannad F
AD  - Inserm, Centre d'Investigation Cliniques CIC 9501 and U961, CHU and Department of 
      Cardiology, Nancy University, Nancy, France. f.zannad@chu-nancy.fr
FAU - McMurray, John J V
AU  - McMurray JJ
FAU - Drexler, Helmut
AU  - Drexler H
FAU - Krum, Henry
AU  - Krum H
FAU - van Veldhuisen, Dirk J
AU  - van Veldhuisen DJ
FAU - Swedberg, Karl
AU  - Swedberg K
FAU - Shi, Harry
AU  - Shi H
FAU - Vincent, John
AU  - Vincent J
FAU - Pitt, Bertram
AU  - Pitt B
LA  - eng
SI  - ClinicalTrials.gov/NCT00232180
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100413
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 0 (Adrenergic beta-Antagonists)
RN  - 0 (Angiotensin-Converting Enzyme Inhibitors)
RN  - 0 (Mineralocorticoid Receptor Antagonists)
RN  - 27O7W4T232 (Spironolactone)
RN  - 6995V82D0B (Eplerenone)
SB  - IM
MH  - Adrenergic beta-Antagonists/therapeutic use
MH  - Angiotensin-Converting Enzyme Inhibitors/therapeutic use
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Eplerenone
MH  - Heart Failure, Systolic/*drug therapy/mortality
MH  - Hospitalization
MH  - Humans
MH  - Mineralocorticoid Receptor Antagonists/*therapeutic use
MH  - Research Design
MH  - Spironolactone/*analogs & derivatives/therapeutic use
MH  - Survival Analysis
EDAT- 2010/04/15 06:00
MHDA- 2010/08/21 06:00
CRDT- 2010/04/15 06:00
PHST- 2010/04/15 06:00 [entrez]
PHST- 2010/04/15 06:00 [pubmed]
PHST- 2010/08/21 06:00 [medline]
AID - hfq049 [pii]
AID - 10.1093/eurjhf/hfq049 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2010 Jun;12(6):617-22. doi: 10.1093/eurjhf/hfq049. Epub 2010 
      Apr 13.