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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00232180




Registration number
NCT00232180
Ethics application status
Date submitted
30/09/2005
Date registered
4/10/2005
Date last updated
19/12/2018

Titles & IDs
Public title
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Scientific title
The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure
Secondary ID [1] 0 0
A6141079
Universal Trial Number (UTN)
Trial acronym
EMPHASIS-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eplerenone

Active Comparator: Eplerenone arm - Eplerenone administered on top of background standard heart failure therapy


Treatment: Drugs: Eplerenone
Eplerenone administered on top of background standard heart failure therapy

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date - CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Timepoint [1] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)
Primary outcome [2] 0 0
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated) - CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Timepoint [2] 0 0
Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [1] 0 0
Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated) - Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Timepoint [1] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [2] 0 0
Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated) - Death due to any cause.
Timepoint [2] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [3] 0 0
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated) - CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism).
Timepoint [3] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [4] 0 0
Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated) - Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).
Timepoint [4] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [5] 0 0
Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated) - First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Timepoint [5] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [6] 0 0
Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated) - Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).
Timepoint [6] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [7] 0 0
Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated) - Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.
Timepoint [7] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [8] 0 0
Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated) - First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator.
Timepoint [8] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [9] 0 0
Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)
Timepoint [9] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [10] 0 0
Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)
Timepoint [10] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [11] 0 0
Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated) - First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal.
Timepoint [11] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [12] 0 0
Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated) - First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure.
Timepoint [12] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [13] 0 0
Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated) - First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level.
Timepoint [13] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [14] 0 0
Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated) - First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L).
Timepoint [14] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [15] 0 0
Number of Participants With New Onset Atrial Fibrillation or Flutter - New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization.
Timepoint [15] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Secondary outcome [16] 0 0
Number of Participants With New Onset Diabetes Mellitus (DM) - The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization.
Timepoint [16] 0 0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Eligibility
Key inclusion criteria
- History (Hx) of chronic systolic heart failure of ischemic or non-ischemic etiology of
at least 4 weeks duration; Currently, New York Heart Association (NYHA) functional
Class II and on optimal dose, or maximally tolerated dose of standard heart failure
medicines (advisable to include ACE-I/ARBs; beta-blockers) and diuretics if indicated
for fluid overload. Should have participated in the double-blind phase of the
EMPHASIS-HF trial
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe chronic systolic heart failure symptomatic at rest despite optimal medical
therapy; estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Concord
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Brisbane
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Launceston
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
7250 - Launceston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
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District of Columbia
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United States of America
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Florida
Country [7] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maine
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Maryland
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Massachusetts
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Mississippi
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Wisconsin
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Argentina
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Pcia. De Buenos Aires
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Plzen
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Praha 10
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Czechia
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Czechia
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Praha 2
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Czechia
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Praha 6
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Pribram
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Chateauroux
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France
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Gap CEDEX
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Nantes Cedex 01
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France
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Nice CEDEX 1
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France
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Nîmes
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Paris CEDEX 13
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St-Amand-Montrond
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Dortmund
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Duisburg
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Essen
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Germany
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Frankfurt/Main
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Germany
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Goettingen
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Germany
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Hagen
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Germany
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Halle
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Germany
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Hannover
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Germany
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Homburg/Saar
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Germany
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Koeln
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Germany
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Leipzig
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Germany
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Ludwigshafen
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Germany
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Luebeck
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Greece
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Attika
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Attiki
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Greece
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Athens
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Greece
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Hong Kong
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Chai Wan
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Hong Kong
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Pokfulam
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Hong Kong
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Shatin NT
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Mosonmagyarovar
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Hungary
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Siófok
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Szeged
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India
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Andhra Pradesh
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India
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Karnataka
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India
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Maharshtra
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India
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Punjab
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India
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Tamil Nadu
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India
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Uttar Pradesh
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Ireland
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Cork
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Italy
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Catania
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Italy
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Firenze
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Italy
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Mestre - Zelardino (VE)
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Milano
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Modena
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Napoli
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Padova
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Italy
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Palermo
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Italy
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Parma
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Italy
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Piacenza
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Italy
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Roma
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Italy
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Sassari
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Italy
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Trieste
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Italy
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Korea, Republic of
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Korea
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Korea, Republic of
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Suwon
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Korea, Republic of
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Taegu
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Aguacalientes
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Mexico
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DF
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Mexico
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Jalisco
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Mexico
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San Luis Potosi
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Netherlands
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's-Hertogenbosch
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Netherlands
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Alkmaar
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Netherlands
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Apeldoorn
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Netherlands
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Arnhem
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Netherlands
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Breda
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Netherlands
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Deventer
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Netherlands
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Dordrecht
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Netherlands
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Eindhoven
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Netherlands
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Groningen
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Netherlands
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Heerlen
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Netherlands
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Veldhoven
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Netherlands
State/province [138] 0 0
Velp
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Netherlands
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Zwolle
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Poland
State/province [140] 0 0
Gdansk
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Piotrkow Trybunalski
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Poland
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Poznan
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Poland
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Stalowa Wola
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Poland
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Szczecin
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Poland
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Warszawa
Country [148] 0 0
Portugal
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Penafiel
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Portugal
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Almada
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Portugal
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Amadora
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Portugal
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Coimbra
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Portugal
State/province [152] 0 0
Linda-a-Velha
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Portugal
State/province [153] 0 0
Lisboa
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Portugal
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Oliveira de Azemeis
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Portugal
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Portalegre
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Portugal
State/province [156] 0 0
Porto
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Portugal
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Vila Franca de Xira
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Portugal
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Vila Real
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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S-Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Voronezh
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Estado Miranda

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In an earlier study, eplerenone was shown to improve survival in patients who had heart
failure immediately following a heart attack. However, it is not known how patients with
established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of
sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus
standard heart failure medicines is being compared to placebo plus standard heart failure
medicines in terms of an additional ability to prolong life and prevent re-hospitalizations
for worsening heart failure in these patients.

The Data Safety Monitoring Committee (DSMC) observed during its conduct of the
protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of
eplerenone had met the pre-specified stopping rules in the protocol. As a result of the
discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended
that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration
that it would be unethical not to offer this treatment to patients, the ESC recommended that
all the patients in the trial should be transferred to open-label eplerenone. The Open Label
Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for
the indication studied in this patient population.

On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered
to be the most appropriate way to ensure that all the subjects who participated in the
double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone
Trial website
https://clinicaltrials.gov/show/NCT00232180
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications