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 (EMPHASIS-HF)

December 19, 2020 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

The Effect Of Eplerenone Versus Placebo On Cardiovascular Mortality And Heart Failure Hospitalization In Subjects With NYHA Class II Chronic Systolic Heart Failure

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2743

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1428
        • Pfizer Investigational Site
      • Cordoba, Argentina, X5003DCE
        • Pfizer Investigational Site
    • Pcia. De Buenos Aires
      • Moron, Pcia. De Buenos Aires, Argentina, 1708
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Pfizer Investigational Site
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Pfizer Investigational Site
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Pfizer Investigational Site
  • Belgium
      • Antwerpen, Belgium, B-2020
        • Pfizer Investigational Site
      • Bonheiden, Belgium, B-2820
        • Pfizer Investigational Site
      • Eupen, Belgium, B-4700
        • Pfizer Investigational Site
      • Genk, Belgium, 3600
        • Pfizer Investigational Site
      • Hasselt, Belgium, 3500
        • Pfizer Investigational Site
      • Huy, Belgium, B-4500
        • Pfizer Investigational Site
      • La Louvière, Belgium, 7100
        • Pfizer Investigational Site
      • Lanaken, Belgium, 3620
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Overpelt, Belgium, B-3900
        • Pfizer Investigational Site
      • Yvoir, Belgium, 5530
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Pfizer Investigational Site
      • Hamilton, Ontario, Canada, L8L 2X2
        • Pfizer Investigational Site
      • London, Ontario, Canada, N6A 5A5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H1T 1C8
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H4J 1C5
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
      • St-Charles Borromee, Quebec, Canada, J6E 6J2
        • Pfizer Investigational Site
      • St-georges (Beauce), Quebec, Canada, G5Y 4T8
        • Pfizer Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • Pfizer Investigational Site
      • Brno, Czechia, 656 91
        • Pfizer Investigational Site
      • Hradec Kralove, Czechia, 500 05
        • Pfizer Investigational Site
      • Ostrava, Czechia, 708 52
        • Pfizer Investigational Site
      • Plzen, Czechia, 30599
        • Pfizer Investigational Site
      • Plzen, Czechia, 323 00
        • Pfizer Investigational Site
      • Praha 1, Czechia, 110 00
        • Pfizer Investigational Site
      • Praha 1, Czechia, 118 33
        • Pfizer Investigational Site
      • Praha 10, Czechia, 100 34
        • Pfizer Investigational Site
      • Praha 2, Czechia, 128 08
        • Pfizer Investigational Site
      • Praha 6, Czechia, 169 02
        • Pfizer Investigational Site
      • Pribram, Czechia, 261 01
        • Pfizer Investigational Site
  • France
      • Angers Cedex 01, France, 49033
        • Pfizer Investigational Site
      • Brest, France, 29200
        • Pfizer Investigational Site
      • Cergy-Pontoise, France, 95303
        • Pfizer Investigational Site
      • Chateauroux, France, 36019
        • Pfizer Investigational Site
      • Gap CEDEX, France, 05007
        • Pfizer Investigational Site
      • Nantes Cedex 01, France, 44093
        • Pfizer Investigational Site
      • Nice CEDEX 1, France, 06002
        • Pfizer Investigational Site
      • Nîmes, France, 30000
        • Pfizer Investigational Site
      • Paris CEDEX 13, France, 75651
        • Pfizer Investigational Site
      • St-Amand-Montrond, France, 18206
        • Pfizer Investigational Site
      • Strasbourg, France, 67091
        • Pfizer Investigational Site
      • Strasbourg, France, 67098
        • Pfizer Investigational Site
      • Valenciennes, France, 59300
        • Pfizer Investigational Site
    • Cedex
      • Creteil, Cedex, France, 94010
        • Pfizer Investigational Site
      • Gap, Cedex, France, 05000
        • Pfizer Investigational Site
    • Cedex 4
      • Toulouse, Cedex 4, France, 31403
        • Pfizer Investigational Site
  • Germany
      • Bad Nauheim, Germany, 61231
        • Pfizer Investigational Site
      • Bad Rothenfelde, Germany, 49214
        • Pfizer Investigational Site
      • Berlin, Germany, 12683
        • Pfizer Investigational Site
      • Berlin, Germany, 13125
        • Pfizer Investigational Site
      • Berlin, Germany, 10367
        • Pfizer Investigational Site
      • Berlin, Germany, 12621
        • Pfizer Investigational Site
      • Dortmund, Germany, 44137
        • Pfizer Investigational Site
      • Duisburg, Germany, 47137
        • Pfizer Investigational Site
      • Essen, Germany, 45122
        • Pfizer Investigational Site
      • Frankfurt/Main, Germany, 60594
        • Pfizer Investigational Site
      • Goettingen, Germany, 37075
        • Pfizer Investigational Site
      • Hagen, Germany, 58095
        • Pfizer Investigational Site
      • Halle, Germany, 06110
        • Pfizer Investigational Site
      • Hannover, Germany, 30625
        • Pfizer Investigational Site
      • Homburg/Saar, Germany, 66424
        • Pfizer Investigational Site
      • Koeln, Germany, 50924
        • Pfizer Investigational Site
      • Leipzig, Germany, 04289
        • Pfizer Investigational Site
      • Ludwigshafen, Germany, 67063
        • Pfizer Investigational Site
      • Luebeck, Germany, 23538
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 11527
        • Pfizer Investigational Site
      • Athens, Greece, 11528
        • Pfizer Investigational Site
      • Athens, Greece, 10671
        • Pfizer Investigational Site
      • Athens, Greece, 14388
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 54636
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 57010
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 54642
        • Pfizer Investigational Site
    • Attika
      • Athens, Attika, Greece, 16672
        • Pfizer Investigational Site
    • Attiki
      • Haidari, Attiki, Greece, 12462
        • Pfizer Investigational Site
  • Hong Kong
      • Chai Wan, Hong Kong
        • Pfizer Investigational Site
      • Pokfulam, Hong Kong
        • Pfizer Investigational Site
      • Shatin NT, Hong Kong
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1529
        • Pfizer Investigational Site
      • Budapest, Hungary, 1106
        • Pfizer Investigational Site
      • Budapest, Hungary, H-1134
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4012
        • Pfizer Investigational Site
      • Mosonmagyarovar, Hungary, 9200
        • Pfizer Investigational Site
      • Siófok, Hungary, 8601
        • Pfizer Investigational Site
      • Szeged, Hungary, H-6720
        • Pfizer Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 001
        • Pfizer Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500 034
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
      • Bangalore, Karnataka, India, 560 054
        • Pfizer Investigational Site
    • Maharshtra
      • Pune, Maharshtra, India, 411 004
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141 001
        • Pfizer Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 400 037
        • Pfizer Investigational Site
      • Coimbatore, Tamil Nadu, India, 641 014
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 014
        • Pfizer Investigational Site
  • Ireland
      • Cork, Ireland
        • Pfizer Investigational Site
      • Dublin, Ireland, 4
        • Pfizer Investigational Site
      • Dublin, Ireland, Co.
        • Pfizer Investigational Site
      • Galway, Ireland
        • Pfizer Investigational Site
  • Italy
      • Bergamo (BG), Italy, 24128
        • Pfizer Investigational Site
      • Catania, Italy, 95123
        • Pfizer Investigational Site
      • Catania, Italy, 95124
        • Pfizer Investigational Site
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Mestre - Zelardino (VE), Italy, 30164
        • Pfizer Investigational Site
      • Milano, Italy, 20138
        • Pfizer Investigational Site
      • Modena, Italy, 41100
        • Pfizer Investigational Site
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Palermo, Italy, 90100
        • Pfizer Investigational Site
      • Parma, Italy, 43100
        • Pfizer Investigational Site
      • Piacenza, Italy, 29100
        • Pfizer Investigational Site
      • Roma, Italy, 00163
        • Pfizer Investigational Site
      • Sassari, Italy, 07100
        • Pfizer Investigational Site
      • Trieste, Italy, 30147
        • Pfizer Investigational Site
      • Venezia, Italy, 30122
        • Pfizer Investigational Site
  • Korea, Republic of
      • Suwon, Korea, Republic of, 443-721
        • Pfizer Investigational Site
      • Taegu, Korea, Republic of, 700-721
        • Pfizer Investigational Site
    • Korea
      • Republic Of Korea, Korea, Korea, Republic of, 120-752
        • Pfizer Investigational Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Pfizer Investigational Site
      • Chihuahua, Mexico, 31238
        • Pfizer Investigational Site
      • San Luis Potosi, Mexico, 78210
        • Pfizer Investigational Site
    • Aguacalientes
      • Aguascalientes, Aguacalientes, Mexico, 20230
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 02720
        • Pfizer Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Pfizer Investigational Site
      • Zapopan, Jalisco, Mexico, 45200
        • Pfizer Investigational Site
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Pfizer Investigational Site
      • Alkmaar, Netherlands, 1815 JD
        • Pfizer Investigational Site
      • Apeldoorn, Netherlands, 7334 DZ
        • Pfizer Investigational Site
      • Apeldoorn, Netherlands, 7314 ET
        • Pfizer Investigational Site
      • Arnhem, Netherlands, 6815 AD
        • Pfizer Investigational Site
      • Breda, Netherlands, 4818 CK
        • Pfizer Investigational Site
      • Deventer, Netherlands, 7416 SE
        • Pfizer Investigational Site
      • Dordrecht, Netherlands, 3317 NM
        • Pfizer Investigational Site
      • Dordrecht, Netherlands, 3318 AT
        • Pfizer Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • Pfizer Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • Pfizer Investigational Site
      • Heerlen, Netherlands, 6419 PC
        • Pfizer Investigational Site
      • Veldhoven, Netherlands, 5504 DB
        • Pfizer Investigational Site
      • Velp, Netherlands, 6883 AZ
        • Pfizer Investigational Site
      • Zwolle, Netherlands, 8011 JW
        • Pfizer Investigational Site
  • Poland
      • Gdansk, Poland, 80-952
        • Pfizer Investigational Site
      • Krakow, Poland, 31-501
        • Pfizer Investigational Site
      • Lodz, Poland, 91-347
        • Pfizer Investigational Site
      • Piotrkow Trybunalski, Poland, 97-300
        • Pfizer Investigational Site
      • Poznan, Poland, 60-834
        • Pfizer Investigational Site
      • Stalowa Wola, Poland, 37-450
        • Pfizer Investigational Site
      • Szczecin, Poland, 71-455
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-097
        • Pfizer Investigational Site
      • Warszawa, Poland, 04-628
        • Pfizer Investigational Site
      • Warszawa, Poland, 03-242
        • Pfizer Investigational Site
  • Portugal
      • Almada, Portugal, 2801-951
        • Pfizer Investigational Site
      • Amadora, Portugal, 2700-276
        • Pfizer Investigational Site
      • Coimbra, Portugal, 3000-075
        • Pfizer Investigational Site
      • Linda-a-Velha, Portugal, 2799-523
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1769-001
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1499-005
        • Pfizer Investigational Site
      • Oliveira de Azemeis, Portugal, 3720-275
        • Pfizer Investigational Site
      • Portalegre, Portugal, 7301-853
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-319
        • Pfizer Investigational Site
      • Vila Franca de Xira, Portugal, 2600-178
        • Pfizer Investigational Site
      • Vila Real, Portugal, 5000
        • Pfizer Investigational Site
    • Penafiel
      • Guilhufe - PNF, Penafiel, Portugal, 4560-162
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 121552
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 113093
        • Pfizer Investigational Site
      • Novosibirsk, Russian Federation, 630089
        • Pfizer Investigational Site
      • S-Petersburg, Russian Federation, 192104
        • Pfizer Investigational Site
      • S-Petersburg, Russian Federation, 197022
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 196084
        • Pfizer Investigational Site
      • Saint-Petersburg, Russian Federation, 195257
        • Pfizer Investigational Site
      • Voronezh, Russian Federation, 394053
        • Pfizer Investigational Site
      • Yaroslavl, Russian Federation, 150030
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 168752
        • Pfizer Investigational Site
      • Singapore, Singapore, 308433
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 811 05
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 813 69
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 831 03
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 03
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 48
        • Pfizer Investigational Site
      • Levice, Slovakia, 934 01
        • Pfizer Investigational Site
      • Liptovsky Mikulas, Slovakia, 031 01
        • Pfizer Investigational Site
      • Nitra, Slovakia, 949 01
        • Pfizer Investigational Site
      • Trencin, Slovakia, 911 01
        • Pfizer Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9300
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7500
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7405
        • Pfizer Investigational Site
      • Congella, South Africa, 4013
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2013
        • Pfizer Investigational Site
      • Kwazulu Natal, South Africa, 4001
        • Pfizer Investigational Site
    • Johannesburg
      • Soweto, Johannesburg, South Africa, 2013
        • Pfizer Investigational Site
  • Spain
      • Almeria, Spain, 04009
        • Pfizer Investigational Site
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Cordoba, Spain, 14004
        • Pfizer Investigational Site
      • Malaga, Spain, 29010
        • Pfizer Investigational Site
    • LA Coruña
      • Santiago de Compostela, LA Coruña, Spain, 15706
        • Pfizer Investigational Site
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Pfizer Investigational Site
  • Sweden
      • Angelholm, Sweden, 262 81
        • Pfizer Investigational Site
      • Bollnas, Sweden, 821 34
        • Pfizer Investigational Site
      • Falun, Sweden, 791 82
        • Pfizer Investigational Site
      • Goteborg, Sweden, 416 85
        • Pfizer Investigational Site
      • Goteborg, Sweden, 413 45
        • Pfizer Investigational Site
      • Göteborg, Sweden, 413 45
        • Pfizer Investigational Site
      • Göteborg, Sweden, SE-416 85
        • Pfizer Investigational Site
      • Halmstad, Sweden, 301 85
        • Pfizer Investigational Site
      • Hässleholm, Sweden, 281 31
        • Pfizer Investigational Site
      • Lindesberg, Sweden, 711 82
        • Pfizer Investigational Site
      • Linkoping, Sweden, 58185
        • Pfizer Investigational Site
      • Lulea, Sweden, 971 80
        • Pfizer Investigational Site
      • Molndal, Sweden, 431 80
        • Pfizer Investigational Site
      • Skelleftea, Sweden, S-931 86
        • Pfizer Investigational Site
      • Varberg, Sweden, 432 41
        • Pfizer Investigational Site
      • Vaxjo, Sweden, 351 85
        • Pfizer Investigational Site
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ukraine, 49023
        • Pfizer Investigational Site
      • Dnipropetrovsk, Ukraine, 49060
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 83003
        • Pfizer Investigational Site
      • Donetsk, Ukraine, 83114
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61002
        • Pfizer Investigational Site
      • Kharkiv, Ukraine, 61000
        • Pfizer Investigational Site
      • Kiev, Ukraine, 03151
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 04050
        • Pfizer Investigational Site
      • Kyiv, Ukraine, 02125
        • Pfizer Investigational Site
      • Lviv, Ukraine, 79013
        • Pfizer Investigational Site
      • Lviv, Ukraine, 79015
        • Pfizer Investigational Site
      • Odessa, Ukraine, 65009
        • Pfizer Investigational Site
      • Odessa, Ukraine, 65039
        • Pfizer Investigational Site
      • Uzhgorod, Ukraine, 88014
        • Pfizer Investigational Site
      • Zaporizhzhia, Ukraine, 69118
        • Pfizer Investigational Site
    • Crimea
      • Simferopol, Crimea, Ukraine, 95026
        • Pfizer Investigational Site
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Pfizer Investigational Site
    • UAE
      • Dubai, UAE, United Arab Emirates
        • Pfizer Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Pfizer Investigational Site
      • Coventry, United Kingdom, CVZ 2DX
        • Pfizer Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G11 6NT
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G12 8TA
        • Pfizer Investigational Site
      • Harrow, United Kingdom, HA1 3UJ
        • Pfizer Investigational Site
      • Larbert, United Kingdom, FK5 4WR
        • Pfizer Investigational Site
      • Macclesfield, United Kingdom, SK10 3BL
        • Pfizer Investigational Site
      • Manchester, United Kingdom, M23 9LT
        • Pfizer Investigational Site
      • Milton Keynes, United Kingdom, MK6 5LD
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S5 7AU
        • Pfizer Investigational Site
      • Southend-on-Sea, United Kingdom, SS0 0RY
        • Pfizer Investigational Site
      • Torquay, United Kingdom, TQ2 7AA
        • Pfizer Investigational Site
    • Cheshire
      • Knutsford, Cheshire, United Kingdom, WA16 0BT
        • Pfizer Investigational Site
      • Macclesfield, Cheshire, United Kingdom, SK10 3BL
        • Pfizer Investigational Site
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BA
        • Pfizer Investigational Site
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G11 6NT
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Pfizer Investigational Site
    • California
      • Loma Linda, California, United States, 92354
        • Pfizer Investigational Site
      • Merced, California, United States, 95340
        • Pfizer Investigational Site
      • Stockton, California, United States, 95204
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Pfizer Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Pfizer Investigational Site
      • Hartford, Connecticut, United States, 06102
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Pfizer Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Pfizer Investigational Site
      • Gainesville, Florida, United States, 32608
        • Pfizer Investigational Site
      • Jupiter, Florida, United States, 33458
        • Pfizer Investigational Site
      • Melbourne, Florida, United States, 32901
        • Pfizer Investigational Site
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46237
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40205-3374
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40216
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pfizer Investigational Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Pfizer Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Pfizer Investigational Site
      • Columbia, Maryland, United States, 21044-2914
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Pfizer Investigational Site
    • Minnesota
      • MN, Minnesota, United States, 55101
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55417
        • Pfizer Investigational Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States, 38801-4600
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68122
        • Pfizer Investigational Site
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14642
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45267
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Pfizer Investigational Site
      • Doylestown, Pennsylvania, United States, 18901
        • Pfizer Investigational Site
      • Leetsdale, Pennsylvania, United States, 15056
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pfizer Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37917
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231-7906
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75024
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational Site
  • Venezuela
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela, 1061
        • Pfizer Investigational Site
    • Estado Miranda
      • Caracas, Estado Miranda, Venezuela, 1060
        • Pfizer Investigational Site
      • Caracas, Estado Miranda, Venezuela, 1061
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eplerenone arm
Eplerenone administered on top of background standard heart failure therapy
Drug: Eplerenone
Eplerenone administered on top of background standard heart failure therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Death due to any cause.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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).
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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).
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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).
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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).
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With New Onset Atrial Fibrillation or Flutter
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
Number of Participants With New Onset Diabetes Mellitus (DM)
Time Frame: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)
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.
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 19, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6141079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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