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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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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
Sex
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
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
2743
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Connecticut
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United States of America
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District of Columbia
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Illinois
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Kentucky
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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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Nebraska
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New Hampshire
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Brno
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Hradec Kralove
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Ostrava
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Czechia
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Plzen
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Czechia
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Praha 10
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Czechia
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Praha 1
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Czechia
State/province [49] 0 0
Praha 2
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Czechia
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Praha 6
Country [51] 0 0
Czechia
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Pribram
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France
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Cedex 4
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Cedex
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Angers Cedex 01
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Brest
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Cergy-Pontoise
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Chateauroux
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France
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Gap CEDEX
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France
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Nantes Cedex 01
Country [60] 0 0
France
State/province [60] 0 0
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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Essen
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Frankfurt/Main
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Goettingen
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Hagen
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Halle
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Hannover
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Homburg/Saar
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Koeln
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Leipzig
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Chai Wan
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Debrecen
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Siófok
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India
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India
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Tamil Nadu
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Dordrecht
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Cordoba
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Angelholm
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Lindesberg
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Linkoping
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Skelleftea
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Sweden
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Varberg
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Sweden
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Vaxjo
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Ukraine
State/province [196] 0 0
Crimea
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Ukraine
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Ukraine
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Kharkiv
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Ukraine
State/province [200] 0 0
Kiev
Country [201] 0 0
Ukraine
State/province [201] 0 0
Kyiv
Country [202] 0 0
Ukraine
State/province [202] 0 0
Lviv
Country [203] 0 0
Ukraine
State/province [203] 0 0
Odessa
Country [204] 0 0
Ukraine
State/province [204] 0 0
Uzhgorod
Country [205] 0 0
Ukraine
State/province [205] 0 0
Zaporizhzhia
Country [206] 0 0
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State/province [206] 0 0
UAE
Country [207] 0 0
United Arab Emirates
State/province [207] 0 0
Abu Dhabi
Country [208] 0 0
United Kingdom
State/province [208] 0 0
Cheshire
Country [209] 0 0
United Kingdom
State/province [209] 0 0
Northern Ireland
Country [210] 0 0
United Kingdom
State/province [210] 0 0
Strathclyde
Country [211] 0 0
United Kingdom
State/province [211] 0 0
Belfast
Country [212] 0 0
United Kingdom
State/province [212] 0 0
Coventry
Country [213] 0 0
United Kingdom
State/province [213] 0 0
Edinburgh
Country [214] 0 0
United Kingdom
State/province [214] 0 0
Glasgow
Country [215] 0 0
United Kingdom
State/province [215] 0 0
Harrow
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Larbert
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Macclesfield
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Manchester
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United Kingdom
State/province [219] 0 0
Milton Keynes
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Sheffield
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Southend-on-Sea
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Torquay
Country [223] 0 0
Venezuela
State/province [223] 0 0
Distrito Capital
Country [224] 0 0
Venezuela
State/province [224] 0 0
Estado Miranda

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00232180