Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maine
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
Rhode Island
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Washington
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Pcia. De Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Cordoba
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerpen
Country [31] 0 0
Belgium
State/province [31] 0 0
Bonheiden
Country [32] 0 0
Belgium
State/province [32] 0 0
Eupen
Country [33] 0 0
Belgium
State/province [33] 0 0
Genk
Country [34] 0 0
Belgium
State/province [34] 0 0
Hasselt
Country [35] 0 0
Belgium
State/province [35] 0 0
Huy
Country [36] 0 0
Belgium
State/province [36] 0 0
La Louvière
Country [37] 0 0
Belgium
State/province [37] 0 0
Lanaken
Country [38] 0 0
Belgium
State/province [38] 0 0
Leuven
Country [39] 0 0
Belgium
State/province [39] 0 0
Overpelt
Country [40] 0 0
Belgium
State/province [40] 0 0
Yvoir
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Czechia
State/province [43] 0 0
Brno
Country [44] 0 0
Czechia
State/province [44] 0 0
Hradec Kralove
Country [45] 0 0
Czechia
State/province [45] 0 0
Ostrava
Country [46] 0 0
Czechia
State/province [46] 0 0
Plzen
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 10
Country [48] 0 0
Czechia
State/province [48] 0 0
Praha 1
Country [49] 0 0
Czechia
State/province [49] 0 0
Praha 2
Country [50] 0 0
Czechia
State/province [50] 0 0
Praha 6
Country [51] 0 0
Czechia
State/province [51] 0 0
Pribram
Country [52] 0 0
France
State/province [52] 0 0
Cedex 4
Country [53] 0 0
France
State/province [53] 0 0
Cedex
Country [54] 0 0
France
State/province [54] 0 0
Angers Cedex 01
Country [55] 0 0
France
State/province [55] 0 0
Brest
Country [56] 0 0
France
State/province [56] 0 0
Cergy-Pontoise
Country [57] 0 0
France
State/province [57] 0 0
Chateauroux
Country [58] 0 0
France
State/province [58] 0 0
Gap CEDEX
Country [59] 0 0
France
State/province [59] 0 0
Nantes Cedex 01
Country [60] 0 0
France
State/province [60] 0 0
Nice CEDEX 1
Country [61] 0 0
France
State/province [61] 0 0
Nîmes
Country [62] 0 0
France
State/province [62] 0 0
Paris CEDEX 13
Country [63] 0 0
France
State/province [63] 0 0
St-Amand-Montrond
Country [64] 0 0
France
State/province [64] 0 0
Strasbourg
Country [65] 0 0
France
State/province [65] 0 0
Valenciennes
Country [66] 0 0
Germany
State/province [66] 0 0
Bad Nauheim
Country [67] 0 0
Germany
State/province [67] 0 0
Bad Rothenfelde
Country [68] 0 0
Germany
State/province [68] 0 0
Berlin
Country [69] 0 0
Germany
State/province [69] 0 0
Dortmund
Country [70] 0 0
Germany
State/province [70] 0 0
Duisburg
Country [71] 0 0
Germany
State/province [71] 0 0
Essen
Country [72] 0 0
Germany
State/province [72] 0 0
Frankfurt/Main
Country [73] 0 0
Germany
State/province [73] 0 0
Goettingen
Country [74] 0 0
Germany
State/province [74] 0 0
Hagen
Country [75] 0 0
Germany
State/province [75] 0 0
Halle
Country [76] 0 0
Germany
State/province [76] 0 0
Hannover
Country [77] 0 0
Germany
State/province [77] 0 0
Homburg/Saar
Country [78] 0 0
Germany
State/province [78] 0 0
Koeln
Country [79] 0 0
Germany
State/province [79] 0 0
Leipzig
Country [80] 0 0
Germany
State/province [80] 0 0
Ludwigshafen
Country [81] 0 0
Germany
State/province [81] 0 0
Luebeck
Country [82] 0 0
Greece
State/province [82] 0 0
Attika
Country [83] 0 0
Greece
State/province [83] 0 0
Attiki
Country [84] 0 0
Greece
State/province [84] 0 0
Athens
Country [85] 0 0
Greece
State/province [85] 0 0
Thessaloniki
Country [86] 0 0
Hong Kong
State/province [86] 0 0
Chai Wan
Country [87] 0 0
Hong Kong
State/province [87] 0 0
Pokfulam
Country [88] 0 0
Hong Kong
State/province [88] 0 0
Shatin NT
Country [89] 0 0
Hungary
State/province [89] 0 0
Budapest
Country [90] 0 0
Hungary
State/province [90] 0 0
Debrecen
Country [91] 0 0
Hungary
State/province [91] 0 0
Mosonmagyarovar
Country [92] 0 0
Hungary
State/province [92] 0 0
Siófok
Country [93] 0 0
Hungary
State/province [93] 0 0
Szeged
Country [94] 0 0
India
State/province [94] 0 0
Andhra Pradesh
Country [95] 0 0
India
State/province [95] 0 0
Karnataka
Country [96] 0 0
India
State/province [96] 0 0
Maharshtra
Country [97] 0 0
India
State/province [97] 0 0
Punjab
Country [98] 0 0
India
State/province [98] 0 0
Tamil Nadu
Country [99] 0 0
India
State/province [99] 0 0
Uttar Pradesh
Country [100] 0 0
Ireland
State/province [100] 0 0
Cork
Country [101] 0 0
Ireland
State/province [101] 0 0
Dublin
Country [102] 0 0
Ireland
State/province [102] 0 0
Galway
Country [103] 0 0
Italy
State/province [103] 0 0
Bergamo (BG)
Country [104] 0 0
Italy
State/province [104] 0 0
Catania
Country [105] 0 0
Italy
State/province [105] 0 0
Firenze
Country [106] 0 0
Italy
State/province [106] 0 0
Mestre - Zelardino (VE)
Country [107] 0 0
Italy
State/province [107] 0 0
Milano
Country [108] 0 0
Italy
State/province [108] 0 0
Modena
Country [109] 0 0
Italy
State/province [109] 0 0
Napoli
Country [110] 0 0
Italy
State/province [110] 0 0
Padova
Country [111] 0 0
Italy
State/province [111] 0 0
Palermo
Country [112] 0 0
Italy
State/province [112] 0 0
Parma
Country [113] 0 0
Italy
State/province [113] 0 0
Piacenza
Country [114] 0 0
Italy
State/province [114] 0 0
Roma
Country [115] 0 0
Italy
State/province [115] 0 0
Sassari
Country [116] 0 0
Italy
State/province [116] 0 0
Trieste
Country [117] 0 0
Italy
State/province [117] 0 0
Venezia
Country [118] 0 0
Korea, Republic of
State/province [118] 0 0
Korea
Country [119] 0 0
Korea, Republic of
State/province [119] 0 0
Suwon
Country [120] 0 0
Korea, Republic of
State/province [120] 0 0
Taegu
Country [121] 0 0
Mexico
State/province [121] 0 0
Aguacalientes
Country [122] 0 0
Mexico
State/province [122] 0 0
DF
Country [123] 0 0
Mexico
State/province [123] 0 0
Jalisco
Country [124] 0 0
Mexico
State/province [124] 0 0
Aguascalientes
Country [125] 0 0
Mexico
State/province [125] 0 0
Chihuahua
Country [126] 0 0
Mexico
State/province [126] 0 0
San Luis Potosi
Country [127] 0 0
Netherlands
State/province [127] 0 0
's-Hertogenbosch
Country [128] 0 0
Netherlands
State/province [128] 0 0
Alkmaar
Country [129] 0 0
Netherlands
State/province [129] 0 0
Apeldoorn
Country [130] 0 0
Netherlands
State/province [130] 0 0
Arnhem
Country [131] 0 0
Netherlands
State/province [131] 0 0
Breda
Country [132] 0 0
Netherlands
State/province [132] 0 0
Deventer
Country [133] 0 0
Netherlands
State/province [133] 0 0
Dordrecht
Country [134] 0 0
Netherlands
State/province [134] 0 0
Eindhoven
Country [135] 0 0
Netherlands
State/province [135] 0 0
Groningen
Country [136] 0 0
Netherlands
State/province [136] 0 0
Heerlen
Country [137] 0 0
Netherlands
State/province [137] 0 0
Veldhoven
Country [138] 0 0
Netherlands
State/province [138] 0 0
Velp
Country [139] 0 0
Netherlands
State/province [139] 0 0
Zwolle
Country [140] 0 0
Poland
State/province [140] 0 0
Gdansk
Country [141] 0 0
Poland
State/province [141] 0 0
Krakow
Country [142] 0 0
Poland
State/province [142] 0 0
Lodz
Country [143] 0 0
Poland
State/province [143] 0 0
Piotrkow Trybunalski
Country [144] 0 0
Poland
State/province [144] 0 0
Poznan
Country [145] 0 0
Poland
State/province [145] 0 0
Stalowa Wola
Country [146] 0 0
Poland
State/province [146] 0 0
Szczecin
Country [147] 0 0
Poland
State/province [147] 0 0
Warszawa
Country [148] 0 0
Portugal
State/province [148] 0 0
Penafiel
Country [149] 0 0
Portugal
State/province [149] 0 0
Almada
Country [150] 0 0
Portugal
State/province [150] 0 0
Amadora
Country [151] 0 0
Portugal
State/province [151] 0 0
Coimbra
Country [152] 0 0
Portugal
State/province [152] 0 0
Linda-a-Velha
Country [153] 0 0
Portugal
State/province [153] 0 0
Lisboa
Country [154] 0 0
Portugal
State/province [154] 0 0
Oliveira de Azemeis
Country [155] 0 0
Portugal
State/province [155] 0 0
Portalegre
Country [156] 0 0
Portugal
State/province [156] 0 0
Porto
Country [157] 0 0
Portugal
State/province [157] 0 0
Vila Franca de Xira
Country [158] 0 0
Portugal
State/province [158] 0 0
Vila Real
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Moscow
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Novosibirsk
Country [161] 0 0
Russian Federation
State/province [161] 0 0
S-Petersburg
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Saint-Petersburg
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Voronezh
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Yaroslavl
Country [165] 0 0
Singapore
State/province [165] 0 0
Singapore
Country [166] 0 0
Slovakia
State/province [166] 0 0
Bratislava
Country [167] 0 0
Slovakia
State/province [167] 0 0
Levice
Country [168] 0 0
Slovakia
State/province [168] 0 0
Liptovsky Mikulas
Country [169] 0 0
Slovakia
State/province [169] 0 0
Nitra
Country [170] 0 0
Slovakia
State/province [170] 0 0
Trencin
Country [171] 0 0
South Africa
State/province [171] 0 0
Johannesburg
Country [172] 0 0
South Africa
State/province [172] 0 0
Bloemfontein
Country [173] 0 0
South Africa
State/province [173] 0 0
Cape Town
Country [174] 0 0
South Africa
State/province [174] 0 0
Congella
Country [175] 0 0
South Africa
State/province [175] 0 0
Kwazulu Natal
Country [176] 0 0
Spain
State/province [176] 0 0
LA Coruña
Country [177] 0 0
Spain
State/province [177] 0 0
Vizcaya
Country [178] 0 0
Spain
State/province [178] 0 0
Almeria
Country [179] 0 0
Spain
State/province [179] 0 0
Barcelona
Country [180] 0 0
Spain
State/province [180] 0 0
Cordoba
Country [181] 0 0
Spain
State/province [181] 0 0
Malaga
Country [182] 0 0
Sweden
State/province [182] 0 0
Angelholm
Country [183] 0 0
Sweden
State/province [183] 0 0
Bollnas
Country [184] 0 0
Sweden
State/province [184] 0 0
Falun
Country [185] 0 0
Sweden
State/province [185] 0 0
Goteborg
Country [186] 0 0
Sweden
State/province [186] 0 0
Göteborg
Country [187] 0 0
Sweden
State/province [187] 0 0
Halmstad
Country [188] 0 0
Sweden
State/province [188] 0 0
Hässleholm
Country [189] 0 0
Sweden
State/province [189] 0 0
Lindesberg
Country [190] 0 0
Sweden
State/province [190] 0 0
Linkoping
Country [191] 0 0
Sweden
State/province [191] 0 0
Lulea
Country [192] 0 0
Sweden
State/province [192] 0 0
Molndal
Country [193] 0 0
Sweden
State/province [193] 0 0
Skelleftea
Country [194] 0 0
Sweden
State/province [194] 0 0
Varberg
Country [195] 0 0
Sweden
State/province [195] 0 0
Vaxjo
Country [196] 0 0
Ukraine
State/province [196] 0 0
Crimea
Country [197] 0 0
Ukraine
State/province [197] 0 0
Dnipropetrovsk
Country [198] 0 0
Ukraine
State/province [198] 0 0
Donetsk
Country [199] 0 0
Ukraine
State/province [199] 0 0
Kharkiv
Country [200] 0 0
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
United Arab Emirates
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
Country [219] 0 0
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
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/ct2/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