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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00232180
Registration number
NCT00232180
Ethics application status
Date submitted
30/09/2005
Date registered
4/10/2005
Date last updated
22/12/2020
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
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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
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Secondary ID [1]
0
0
A6141079
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Universal Trial Number (UTN)
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Trial acronym
EMPHASIS-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
0
0
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)
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Primary outcome [2]
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Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)
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Assessment method [2]
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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.
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Timepoint [2]
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0
Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)
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Secondary outcome [1]
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Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
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Assessment method [1]
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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.
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Timepoint [1]
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0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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Secondary outcome [2]
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0
Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)
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Assessment method [2]
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Death due to any cause.
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Timepoint [2]
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Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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Secondary outcome [3]
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0
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)
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Assessment method [3]
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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).
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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)
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Secondary outcome [4]
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0
Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)
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Assessment method [4]
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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).
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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)
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Secondary outcome [5]
0
0
Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)
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Assessment method [5]
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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.
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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)
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Secondary outcome [6]
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0
Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)
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Assessment method [6]
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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).
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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)
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Secondary outcome [7]
0
0
Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
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Assessment method [7]
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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.
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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)
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Secondary outcome [8]
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0
Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)
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Assessment method [8]
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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.
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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)
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Secondary outcome [9]
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Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)
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Assessment method [9]
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0
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Timepoint [9]
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Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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Secondary outcome [10]
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0
Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)
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Assessment method [10]
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0
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Timepoint [10]
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Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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Secondary outcome [11]
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Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)
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Assessment method [11]
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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.
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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)
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Secondary outcome [12]
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0
Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)
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Assessment method [12]
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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.
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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)
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Secondary outcome [13]
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Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)
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Assessment method [13]
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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.
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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)
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Secondary outcome [14]
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0
Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)
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Assessment method [14]
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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).
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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)
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Secondary outcome [15]
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0
Number of Participants With New Onset Atrial Fibrillation or Flutter
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Assessment method [15]
0
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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.
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Timepoint [15]
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0
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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Secondary outcome [16]
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Number of Participants With New Onset Diabetes Mellitus (DM)
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Assessment method [16]
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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.
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Timepoint [16]
0
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Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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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
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2012
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Sample size
Target
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Accrual to date
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Final
2743
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS
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Recruitment hospital [1]
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0
Pfizer Investigational Site - Concord
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Recruitment hospital [2]
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Pfizer Investigational Site - Brisbane
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Recruitment hospital [3]
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Pfizer Investigational Site - Launceston
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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4029 - Brisbane
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Recruitment postcode(s) [3]
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7250 - Launceston
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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United States of America
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Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
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United States of America
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Indiana
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Kentucky
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State/province [10]
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Louisiana
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Maine
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Maryland
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Massachusetts
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Minnesota
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Mississippi
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Nebraska
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Argentina
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Pcia. De Buenos Aires
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Argentina
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Buenos Aires
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Nice CEDEX 1
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Germany
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Germany
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Germany
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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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Greece
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Harrow
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Torquay
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Venezuela
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Distrito Capital
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Venezuela
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Estado Miranda
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Ethics approval
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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
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Trial website
https://clinicaltrials.gov/study/NCT00232180
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Trial related presentations / publications
Vaduganathan M, Ferreira JP, Rossignol P, Neuen BL, Claggett BL, Pfeffer MA, McMurray JJV, Pitt B, Zannad F, Solomon SD. Effects of steroidal mineralocorticoid receptor antagonists on acute and chronic estimated glomerular filtration rate slopes in patients with chronic heart failure. Eur J Heart Fail. 2022 Sep;24(9):1586-1590. doi: 10.1002/ejhf.2635. Epub 2022 Aug 31. Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WHW, Bohm M, Pitt B, Zannad F, Rossignol P. Prognostic relevance of magnesium alterations in patients with a myocardial infarction and left ventricular dysfunction: insights from the EPHESUS trial. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):148-159. doi: 10.1093/ehjacc/zuab111. Ferreira JP, Lamiral Z, McMurray JJV, Swedberg K, van Veldhuisen DJ, Vincent J, Rossignol P, Pocock SJ, Pitt B, Zannad F. Impact of Insulin Treatment on the Effect of Eplerenone: Insights From the EMPHASIS-HF Trial. Circ Heart Fail. 2021 Jun;14(6):e008075. doi: 10.1161/CIRCHEARTFAILURE.120.008075. Epub 2021 Jun 15. Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WWH, Bohm M, Pitt B, Zannad F, Rossignol P. Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial. Clin Res Cardiol. 2022 Apr;111(4):380-392. doi: 10.1007/s00392-021-01853-8. Epub 2021 Apr 23. Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4. Monzo L, Ferreira JP, Abreu P, Szumski A, Bohm M, McMurray JJV, Pitt B, Swedberg K, van Veldhuisen DJ, Girerd N, Vincent J, Zannad F, Rossignol P. Visit-to-visit blood pressure variation and outcomes in heart failure with reduced ejection fraction: findings from the Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms trial. J Hypertens. 2020 Mar;38(3):420-425. doi: 10.1097/HJH.0000000000002275. Stienen S, Ferreira JP, Vincent J, Busselen M, Li B, McMurray JJV, Pitt B, Girerd N, Rossignol P, Zannad F. Estimated Long-Term Survival With Eplerenone. J Am Coll Cardiol. 2019 May 14;73(18):2357-2359. doi: 10.1016/j.jacc.2019.02.043. No abstract available. Ferreira JP, Duarte K, McMurray JJV, Pitt B, van Veldhuisen DJ, Vincent J, Ahmad T, Tromp J, Rossignol P, Zannad F. Data-Driven Approach to Identify Subgroups of Heart Failure With Reduced Ejection Fraction Patients With Different Prognoses and Aldosterone Antagonist Response Patterns. Circ Heart Fail. 2018 Jul;11(7):e004926. doi: 10.1161/CIRCHEARTFAILURE.118.004926. Rossignol P, Dobre D, McMurray JJ, Swedberg K, Krum H, van Veldhuisen DJ, Shi H, Messig M, Vincent J, Girerd N, Bakris G, Pitt B, Zannad F. Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Circ Heart Fail. 2014 Jan;7(1):51-8. doi: 10.1161/CIRCHEARTFAILURE.113.000792. Epub 2013 Dec 2. Eschalier R, McMurray JJ, Swedberg K, van Veldhuisen DJ, Krum H, Pocock SJ, Shi H, Vincent J, Rossignol P, Zannad F, Pitt B; EMPHASIS-HF Investigators. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013 Oct 22;62(17):1585-93. doi: 10.1016/j.jacc.2013.04.086. Epub 2013 Jun 27. Krum H, Shi H, Pitt B, McMurray J, Swedberg K, van Veldhuisen DJ, Vincent J, Pocock S, Zannad F; EMPHASIS-HF Study Group. Clinical benefit of eplerenone in patients with mild symptoms of systolic heart failure already receiving optimal best practice background drug therapy: analysis of the EMPHASIS-HF study. Circ Heart Fail. 2013 Jul;6(4):711-8. doi: 10.1161/CIRCHEARTFAILURE.112.000173. Epub 2013 Apr 26. Rogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation. 2012 Nov 6;126(19):2317-23. doi: 10.1161/CIRCULATIONAHA.112.110536. Epub 2012 Oct 5. Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14. Zannad F, McMurray JJ, Drexler H, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF). Eur J Heart Fail. 2010 Jun;12(6):617-22. doi: 10.1093/eurjhf/hfq049. Epub 2010 Apr 13.
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