AzTrials
AzTrials

Heart FailurePhase 3EMPHASIS-HFNCT00232180

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

A Phase 3 study testing Eplerenone in people with Heart Failure, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 307 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Heart Failure
What is being tested?
Eplerenone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,743 participants
Where
307 sitesin 29 countries
Study dates
Mar 2006to Jan 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Severe chronic systolic heart failure symptomatic at rest despite optimal medical therapy; estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2.

Trial locations and contacts

307 sites in 29 countries.

307 sites in 29 countries

United States51 sites

  • Pfizer Investigational Site

    Albany, New York, 12208

  • Pfizer Investigational Site

    Annapolis, Maryland, 21401

  • Pfizer Investigational Site

    Bangor, Maine, 04401

  • Pfizer Investigational Site

    Baton Rouge, Louisiana, 70808

  • Pfizer Investigational Site

    Beaver, Pennsylvania, 15009

  • Pfizer Investigational Site

    Boston, Massachusetts, 02118

  • Pfizer Investigational Site

    Bridgeport, Connecticut, 06606

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45219

  • Pfizer Investigational Site

    Cincinnati, Ohio, 45267

  • Pfizer Investigational Site

    Colorado Springs, Colorado, 80909

  • Pfizer Investigational Site

    Columbia, Maryland, 21044-2914

  • Pfizer Investigational Site

    Cumberland, Rhode Island, 02864

  • Pfizer Investigational Site

    Dallas, Texas, 75231-7906

  • Pfizer Investigational Site

    Dallas, Texas, 75231

  • Pfizer Investigational Site

    Daytona Beach, Florida, 32117

  • Pfizer Investigational Site

    Doylestown, Pennsylvania, 18901

  • Pfizer Investigational Site

    Gainesville, Florida, 32608

  • Pfizer Investigational Site

    Germantown, Tennessee, 38138

  • Pfizer Investigational Site

    Hartford, Connecticut, 06102

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46237

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46260

  • Pfizer Investigational Site

    Jupiter, Florida, 33458

  • Pfizer Investigational Site

    Knoxville, Tennessee, 37917

  • Pfizer Investigational Site

    Leetsdale, Pennsylvania, 15056

  • Pfizer Investigational Site

    Loma Linda, California, 92354

  • Pfizer Investigational Site

    Louisville, Kentucky, 40202

  • Pfizer Investigational Site

    Louisville, Kentucky, 40205-3374

  • Pfizer Investigational Site

    Louisville, Kentucky, 40216

  • Pfizer Investigational Site

    Madison, Wisconsin, 53792

  • Pfizer Investigational Site

    Manchester, New Hampshire, 03102

  • Pfizer Investigational Site

    Melbourne, Florida, 32901

  • Pfizer Investigational Site

    Merced, California, 95340

  • Pfizer Investigational Site

    Minneapolis, Minnesota, 55417

  • Pfizer Investigational Site

    MN, Minnesota, 55101

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73112

  • Pfizer Investigational Site

    Omaha, Nebraska, 68114

  • Pfizer Investigational Site

    Omaha, Nebraska, 68122

  • Pfizer Investigational Site

    Omaha, Nebraska, 68131

  • Pfizer Investigational Site

    Phoenix, Arizona, 85008

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • Pfizer Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • Pfizer Investigational Site

    Plano, Texas, 75024

  • Pfizer Investigational Site

    Rochester, New York, 14618

  • Pfizer Investigational Site

    Rochester, New York, 14642

  • Pfizer Investigational Site

    Rockford, Illinois, 61107

  • Pfizer Investigational Site

    Spokane, Washington, 99204

  • Pfizer Investigational Site

    Stockton, California, 95204

  • Pfizer Investigational Site

    Tupelo, Mississippi, 38801-4600

  • Pfizer Investigational Site

    Tupelo, Mississippi, 38801

  • Pfizer Investigational Site

    Washington D.C., District of Columbia, 20037

Other trials in United States

Germany19 sites

  • Pfizer Investigational Site

    Bad Nauheim, 61231

  • Pfizer Investigational Site

    Bad Rothenfelde, 49214

  • Pfizer Investigational Site

    Berlin, 10367

  • Pfizer Investigational Site

    Berlin, 12621

  • Pfizer Investigational Site

    Berlin, 12683

  • Pfizer Investigational Site

    Berlin, 13125

  • Pfizer Investigational Site

    Cologne, 50924

  • Pfizer Investigational Site

    Dortmund, 44137

  • Pfizer Investigational Site

    Duisburg, 47137

  • Pfizer Investigational Site

    Essen, 45122

  • Pfizer Investigational Site

    Frankfurt am Main, 60594

  • Pfizer Investigational Site

    Göttingen, 37075

  • Pfizer Investigational Site

    Hagen, 58095

  • Pfizer Investigational Site

    Halle, 06110

  • Pfizer Investigational Site

    Hanover, 30625

  • Pfizer Investigational Site

    Homburg/Saar, 66424

  • Pfizer Investigational Site

    Leipzig, 04289

  • Pfizer Investigational Site

    Lübeck, 23538

  • Pfizer Investigational Site

    Ludwigshafen, 67063

Other trials in Germany

Ukraine17 sites

  • Pfizer Investigational Site

    Dnipropetrovsk, 49005

  • Pfizer Investigational Site

    Dnipropetrovsk, 49023

  • Pfizer Investigational Site

    Dnipropetrovsk, 49060

  • Pfizer Investigational Site

    Donetsk, 83003

  • Pfizer Investigational Site

    Donetsk, 83114

  • Pfizer Investigational Site

    Kharkiv, 61000

  • Pfizer Investigational Site

    Kharkiv, 61002

  • Pfizer Investigational Site

    Kiev, 03151

  • Pfizer Investigational Site

    Kyiv, 02125

  • Pfizer Investigational Site

    Kyiv, 04050

  • Pfizer Investigational Site

    Lviv, 79013

  • Pfizer Investigational Site

    Lviv, 79015

  • Pfizer Investigational Site

    Odesa, 65009

  • Pfizer Investigational Site

    Odesa, 65039

  • Pfizer Investigational Site

    Simferopol, Autonomous Republic of Crimea, 95026

  • Pfizer Investigational Site

    Uzhhorod, 88014

  • Pfizer Investigational Site

    Zaporizhzhya, 69118

Other trials in Ukraine

United Kingdom17 sites

  • Pfizer Investigational Site

    Belfast, Northern Ireland, BT12 6BA

  • Pfizer Investigational Site

    Belfast, BT12 6BA

  • Pfizer Investigational Site

    Coventry, CVZ 2DX

  • Pfizer Investigational Site

    Edinburgh, EH4 2XU

  • Pfizer Investigational Site

    Glasgow, Strathclyde, G11 6NT

  • Pfizer Investigational Site

    Glasgow, G11 6NT

  • Pfizer Investigational Site

    Glasgow, G12 8TA

  • Pfizer Investigational Site

    Harrow, HA1 3UJ

  • Pfizer Investigational Site

    Knutsford, Cheshire, WA16 0BT

  • Pfizer Investigational Site

    Larbert, FK5 4WR

  • Pfizer Investigational Site

    Macclesfield, Cheshire, SK10 3BL

  • Pfizer Investigational Site

    Macclesfield, SK10 3BL

  • Pfizer Investigational Site

    Manchester, M23 9LT

  • Pfizer Investigational Site

    Milton Keynes, MK6 5LD

  • Pfizer Investigational Site

    Sheffield, S5 7AU

  • Pfizer Investigational Site

    Southend-on-Sea, SS0 0RY

  • Pfizer Investigational Site

    Torquay, TQ2 7AA

Other trials in United Kingdom

France16 sites

  • Pfizer Investigational Site

    Angers, 49033

  • Pfizer Investigational Site

    Brest, 29200

  • Pfizer Investigational Site

    Cergy-Pontoise, 95303

  • Pfizer Investigational Site

    Châteauroux, 36019

  • Pfizer Investigational Site

    Créteil, Cedex, 94010

  • Pfizer Investigational Site

    Gap, Cedex, 05000

  • Pfizer Investigational Site

    Gap, 05007

  • Pfizer Investigational Site

    Nantes, 44093

  • Pfizer Investigational Site

    Nice, 06002

  • Pfizer Investigational Site

    Nîmes, 30000

  • Pfizer Investigational Site

    Paris, 75651

  • Pfizer Investigational Site

    Saint-Amand-Montrond, 18206

  • Pfizer Investigational Site

    Strasbourg, 67091

  • Pfizer Investigational Site

    Strasbourg, 67098

  • Pfizer Investigational Site

    Toulouse, Cedex 4, 31403

  • Pfizer Investigational Site

    Valenciennes, 59300

Other trials in France

Italy16 sites

  • Pfizer Investigational Site

    Bergamo (BG), 24128

  • Pfizer Investigational Site

    Catania, 95123

  • Pfizer Investigational Site

    Catania, 95124

  • Pfizer Investigational Site

    Florence, 50134

  • Pfizer Investigational Site

    Mestre - Zelardino (VE), 30164

  • Pfizer Investigational Site

    Milan, 20138

  • Pfizer Investigational Site

    Modena, 41100

  • Pfizer Investigational Site

    Naples, 80131

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Palermo, 90100

  • Pfizer Investigational Site

    Parma, 43100

  • Pfizer Investigational Site

    Piacenza, 29100

  • Pfizer Investigational Site

    Roma, 00163

  • Pfizer Investigational Site

    Sassari, 07100

  • Pfizer Investigational Site

    Trieste, 30147

  • Pfizer Investigational Site

    Venezia, 30122

Other trials in Italy

Netherlands15 sites

  • Pfizer Investigational Site

    's-Hertogenbosch, 5211 NL

  • Pfizer Investigational Site

    Alkmaar, 1815 JD

  • Pfizer Investigational Site

    Apeldoorn, 7314 ET

  • Pfizer Investigational Site

    Apeldoorn, 7334 DZ

  • Pfizer Investigational Site

    Arnhem, 6815 AD

  • Pfizer Investigational Site

    Breda, 4818 CK

  • Pfizer Investigational Site

    Deventer, 7416 SE

  • Pfizer Investigational Site

    Dordrecht, 3317 NM

  • Pfizer Investigational Site

    Dordrecht, 3318 AT

  • Pfizer Investigational Site

    Eindhoven, 5623 EJ

  • Pfizer Investigational Site

    Groningen, 9713 GZ

  • Pfizer Investigational Site

    Heerlen, 6419 PC

  • Pfizer Investigational Site

    Veldhoven, 5504 DB

  • Pfizer Investigational Site

    Velp, 6883 AZ

  • Pfizer Investigational Site

    Zwolle, 8011 JW

Other trials in Netherlands

Sweden15 sites

  • Pfizer Investigational Site

    Ängelholm, 262 81

  • Pfizer Investigational Site

    Bollnäs, 821 34

  • Pfizer Investigational Site

    Falun, 791 82

  • Pfizer Investigational Site

    Gothenburg, 413 45

  • Pfizer Investigational Site

    Gothenburg, 416 85

  • Pfizer Investigational Site

    Gothenburg, SE-416 85

  • Pfizer Investigational Site

    Halmstad, 301 85

  • Pfizer Investigational Site

    Hässleholm, 281 31

  • Pfizer Investigational Site

    Lindesberg, 711 82

  • Pfizer Investigational Site

    Linköping, 58185

  • Pfizer Investigational Site

    Luleå, 971 80

  • Pfizer Investigational Site

    Mölndal, 431 80

  • Pfizer Investigational Site

    Skellefteå, S-931 86

  • Pfizer Investigational Site

    Varberg, 432 41

  • Pfizer Investigational Site

    Vaxjo, 351 85

Other trials in Sweden

Czechia12 sites

  • Pfizer Investigational Site

    Brno, 625 00

  • Pfizer Investigational Site

    Brno, 656 91

  • Pfizer Investigational Site

    Hradec Králové, 500 05

  • Pfizer Investigational Site

    Ostrava, 708 52

  • Pfizer Investigational Site

    Pilsen, 30599

  • Pfizer Investigational Site

    Pilsen, 323 00

  • Pfizer Investigational Site

    Prague, 100 34

  • Pfizer Investigational Site

    Prague, 110 00

  • Pfizer Investigational Site

    Prague, 118 33

  • Pfizer Investigational Site

    Prague, 128 08

  • Pfizer Investigational Site

    Prague, 169 02

  • Pfizer Investigational Site

    Příbram, 261 01

Other trials in Czechia

Portugal12 sites

  • Pfizer Investigational Site

    Almada, 2801-951

  • Pfizer Investigational Site

    Amadora, 2700-276

  • Pfizer Investigational Site

    Coimbra, 3000-075

  • Pfizer Investigational Site

    Guilhufe - PNF, Penafiel, 4560-162

  • Pfizer Investigational Site

    Linda a Velha, 2799-523

  • Pfizer Investigational Site

    Lisbon, 1499-005

  • Pfizer Investigational Site

    Lisbon, 1769-001

  • Pfizer Investigational Site

    Oliveira de Azeméis, 3720-275

  • Pfizer Investigational Site

    Portalegre, 7301-853

  • Pfizer Investigational Site

    Porto, 4200-319

  • Pfizer Investigational Site

    Vila Franca de Xira, 2600-178

  • Pfizer Investigational Site

    Vila Real, 5000

Other trials in Portugal

Belgium11 sites

  • Pfizer Investigational Site

    Antwerp, B-2020

  • Pfizer Investigational Site

    Bonheiden, B-2820

  • Pfizer Investigational Site

    Eupen, B-4700

  • Pfizer Investigational Site

    Genk, 3600

  • Pfizer Investigational Site

    Hasselt, 3500

  • Pfizer Investigational Site

    Huy, B-4500

  • Pfizer Investigational Site

    La Louvière, 7100

  • Pfizer Investigational Site

    Lanaken, 3620

  • Pfizer Investigational Site

    Leuven, 3000

  • Pfizer Investigational Site

    Overpelt, B-3900

  • Pfizer Investigational Site

    Yvoir, 5530

Other trials in Belgium

Canada10 sites

  • Pfizer Investigational Site

    Hamilton, Ontario, L8L 2X2

  • Pfizer Investigational Site

    Hamilton, Ontario, L8N 3Z5

  • Pfizer Investigational Site

    London, Ontario, N6A 5A5

  • Pfizer Investigational Site

    Montreal, Quebec, H1T 1C8

  • Pfizer Investigational Site

    Montreal, Quebec, H3G 1A4

  • Pfizer Investigational Site

    Montreal, Quebec, H4J 1C5

  • Pfizer Investigational Site

    Québec, Quebec, G1V 4G5

  • Pfizer Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 6J2

  • Pfizer Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • Pfizer Investigational Site

    St-georges (Beauce), Quebec, G5Y 4T8

Other trials in Canada

Poland10 sites

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Krakow, 31-501

  • Pfizer Investigational Site

    Lodz, 91-347

  • Pfizer Investigational Site

    Piotrkow Trybunalski, 97-300

  • Pfizer Investigational Site

    Poznan, 60-834

  • Pfizer Investigational Site

    Stalowa Wola, 37-450

  • Pfizer Investigational Site

    Szczecin, 71-455

  • Pfizer Investigational Site

    Warsaw, 02-097

  • Pfizer Investigational Site

    Warsaw, 03-242

  • Pfizer Investigational Site

    Warsaw, 04-628

Other trials in Poland

Greece9 sites

  • Pfizer Investigational Site

    Athens, Attica, 16672

  • Pfizer Investigational Site

    Athens, 10671

  • Pfizer Investigational Site

    Athens, 11527

  • Pfizer Investigational Site

    Athens, 11528

  • Pfizer Investigational Site

    Athens, 14388

  • Pfizer Investigational Site

    Haidari, Attica, 12462

  • Pfizer Investigational Site

    Thessaloniki, 54636

  • Pfizer Investigational Site

    Thessaloniki, 54642

  • Pfizer Investigational Site

    Thessaloniki, 57010

Other trials in Greece

India9 sites

  • Pfizer Investigational Site

    Bangalore, Karnataka, 560 034

  • Pfizer Investigational Site

    Bangalore, Karnataka, 560 054

  • Pfizer Investigational Site

    Chennai, Tamil Nadu, 400 037

  • Pfizer Investigational Site

    Coimbatore, Tamil Nadu, 641 014

  • Pfizer Investigational Site

    Hyderabad, Andhra Pradesh, 500 001

  • Pfizer Investigational Site

    Hyderabad, Andhra Pradesh, 500 034

  • Pfizer Investigational Site

    Lucknow, Uttar Pradesh, 226 014

  • Pfizer Investigational Site

    Ludhiana, Punjab, 141 001

  • Pfizer Investigational Site

    Pune, Maharshtra, 411 004

Other trials in India

Russia9 sites

  • Pfizer Investigational Site

    Moscow, 113093

  • Pfizer Investigational Site

    Moscow, 121552

  • Pfizer Investigational Site

    Novosibirsk, 630089

  • Pfizer Investigational Site

    S-Petersburg, 192104

  • Pfizer Investigational Site

    S-Petersburg, 197022

  • Pfizer Investigational Site

    Saint Petersburg, 195257

  • Pfizer Investigational Site

    Saint Petersburg, 196084

  • Pfizer Investigational Site

    Voronezh, 394053

  • Pfizer Investigational Site

    Yaroslavl, 150030

Other trials in Russia

Slovakia9 sites

  • Pfizer Investigational Site

    Bratislava, 811 05

  • Pfizer Investigational Site

    Bratislava, 813 69

  • Pfizer Investigational Site

    Bratislava, 831 03

  • Pfizer Investigational Site

    Bratislava, 833 03

  • Pfizer Investigational Site

    Bratislava, 833 48

  • Pfizer Investigational Site

    Levice, 934 01

  • Pfizer Investigational Site

    Liptovský Mikuláš, 031 01

  • Pfizer Investigational Site

    Nitra, 949 01

  • Pfizer Investigational Site

    Trenčín, 911 01

Other trials in Slovakia

Hungary7 sites

  • Pfizer Investigational Site

    Budapest, 1106

  • Pfizer Investigational Site

    Budapest, 1529

  • Pfizer Investigational Site

    Budapest, H-1134

  • Pfizer Investigational Site

    Debrecen, 4012

  • Pfizer Investigational Site

    Mosonmagyaróvár, 9200

  • Pfizer Investigational Site

    Siófok, 8601

  • Pfizer Investigational Site

    Szeged, H-6720

Other trials in Hungary

Mexico7 sites

  • Pfizer Investigational Site

    Aguascalientes, Aguacalientes, 20230

  • Pfizer Investigational Site

    Aguascalientes, 20230

  • Pfizer Investigational Site

    Chihuahua City, 31238

  • Pfizer Investigational Site

    Guadalajara, Jalisco, 44280

  • Pfizer Investigational Site

    Mexico City, Mexico City, 02720

  • Pfizer Investigational Site

    San Luis Potosí City, 78210

  • Pfizer Investigational Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

South Africa7 sites

  • Pfizer Investigational Site

    Bloemfontein, 9300

  • Pfizer Investigational Site

    Cape Town, 7405

  • Pfizer Investigational Site

    Cape Town, 7500

  • Pfizer Investigational Site

    Johannesburg, 2013

  • Pfizer Investigational Site

    KwaKhangela, 4013

  • Pfizer Investigational Site

    Kwazulu Natal, 4001

  • Pfizer Investigational Site

    Soweto, Johannesburg, 2013

Other trials in South Africa

Spain6 sites

  • Pfizer Investigational Site

    Almería, 04009

  • Pfizer Investigational Site

    Barakaldo, Vizcaya, 48903

  • Pfizer Investigational Site

    Barcelona, 08035

  • Pfizer Investigational Site

    Córdoba, 14004

  • Pfizer Investigational Site

    Málaga, 29010

  • Pfizer Investigational Site

    Santiago de Compostela, LA Coruña, 15706

Other trials in Spain

Ireland4 sites

  • Pfizer Investigational Site

    Cork

  • Pfizer Investigational Site

    Dublin, 4

  • Pfizer Investigational Site

    Dublin, Co.

  • Pfizer Investigational Site

    Galway

Other trials in Ireland

Argentina3 sites

  • Pfizer Investigational Site

    Buenos Aires, 1428

  • Pfizer Investigational Site

    Córdoba, X5003DCE

  • Pfizer Investigational Site

    Morón, Pcia. de Buenos Aires, 1708

Other trials in Argentina

Australia3 sites

  • Pfizer Investigational Site

    Brisbane, Queensland, 4029

  • Pfizer Investigational Site

    Concord, New South Wales, 2139

  • Pfizer Investigational Site

    Launceston, Tasmania, 7250

Other trials in Australia

Hong Kong3 sites

  • Pfizer Investigational Site

    Chai Wan

  • Pfizer Investigational Site

    Pokfulam

  • Pfizer Investigational Site

    Shatin NT

Other trials in Hong Kong

South Korea3 sites

  • Pfizer Investigational Site

    Republic of Korea, Korea, 120-752

  • Pfizer Investigational Site

    Suwon, 443-721

  • Pfizer Investigational Site

    Taegu, 700-721

Other trials in South Korea

Venezuela3 sites

  • Pfizer Investigational Site

    Caracas, Distrito Federal, 1061

  • Pfizer Investigational Site

    Caracas, Miranda, 1060

  • Pfizer Investigational Site

    Caracas, Miranda, 1061

Other trials in Venezuela

Singapore2 sites

  • Pfizer Investigational Site

    Singapore, 168752

  • Pfizer Investigational Site

    Singapore, 308433

Other trials in Singapore

United Arab Emirates2 sites

  • Pfizer Investigational Site

    Abu Dhabi

  • Pfizer Investigational Site

    Dubai, UAE

Other trials in United Arab Emirates

About this study

Official title: 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

Conditions
Heart Failure
Being tested
Eplerenone
Keywords
Open-label, single arm mortality/morbidity trial eplerenone chronic systolic heart failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EplerenoneDrug

    Eplerenone administered on top of background standard heart failure therapy

Study groups in NCT00232180
Study groupRoleWhat they receive
Eplerenone armActive comparatorEplerenone administered on top of background standard heart failure therapy
Receives: Drug: Eplerenone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date

    CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)

  2. Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)

    CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.

    Measured: Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)

Secondary outcomes (16)

  1. Number of Participants With First Occurrence of All-Cause Mortality or Heart Failure (HF) Hospitalization (Adjudicated)

    Death due to any cause or first of occurrence HF hospitalization. HF hospitalization is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  2. Number of Participants With First Occurrence of All-Cause Mortality (Adjudicated)

    Death due to any cause.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  3. Number of Participants With First Occurrence of Cardiovascular (CV) Mortality (Adjudicated)

    CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism).

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  4. Number of Participants With First Occurrence of All-Cause Hospitalization (Adjudicated)

    Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  5. Number of Participants With First Occurrence of Heart Failure (HF) Hospitalization (Adjudicated)

    First occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  6. Number of Participants With First Occurrence of All-Cause Mortality or All-Cause Hospitalization (Adjudicated)

    Death due to any cause or hospitalization due to any cause. Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility).

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  7. Number of Participants With First Occurrence Of Heart Failure (HF) Mortality or Heart Failure (HF) Hospitalization (Adjudicated)

    Death due to HF or first occurrence of HF hospitalization. Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  8. Number of Participants With First Occurrence of Cardiovascular (CV) Hospitalization (Adjudicated)

    First occurrence of CV hospitalization. CV hospitalization is defined as hospitalization due to HF (first or subsequent), acute myocardial infarction, angina pectoris (unstable), cardiac arrhythmia (atrial fibrillation [AF], atrial flutter, supraventricular arrhythmias, or ventricular arrhythmias), stroke/CVA, other CV reasons (such as hypotension or peripheral vascular disease), implantation of a cardioverter defibrillator (ICD), or cardiac resynchronization therapy (CRT) with CV event as the primary reason for hospitalization as determined by endpoint committee adjudicator.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  9. Number of Participants With First Occurrence of Fatal or Non-fatal Myocardial Infarction (Adjudicated)

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  10. Number of Participants With First Occurrence of Fatal or Non-fatal Stroke (Adjudicated)

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  11. Number of Participants With First Occurrence of Implantation of Cardiac Defibrillator (ICD) (Adjudicated)

    First occurrence of implantation of cardiac defibrillator (ICD). ICD is an electronic device capable of monitoring the heart rhythm. When the heart is beating normally, the device remains inactive. If the heart develops a life-threatening tachycardia, the ICD delivers electrical shocks to the heart to terminate the abnormal rhythm and return the heart rhythm to normal.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  12. Number of Participants With First Occurrence of Implantation of Resynchronization Device (Cardiac Resynchronization Therapy [CRT]) (Adjudicated)

    First occurrence of implantation of resynchronization device. CRT is use of a specialized pacemaker to re-coordinate the action of the right and left ventricles in heart failure.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  13. Number of Participants With First Occurrence of Hospitalization Due to Worsening Renal Function (Adjudicated)

    First occurrence of hospitalization due to worsening renal function. Hospitalization due to worsening renal function is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to worsening renal function as the primary reason for hospitalization as determined by endpoint committee adjudicator. Worsening renal function is defined as doubling of serum creatinine level from baseline level.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  14. Number of Participants With First Occurrence of Hospitalization Due to Hyperkalemia (Adjudicated)

    First occurrence of hospitalization due to hyperkalemia. Hospitalization due to hyperkalemia is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to hyperkalemia as the primary reason for hospitalization as determined by endpoint committee adjudicator. Hyperkalemia is defined as serum potassium level greater than (>) 5.5 milliequivalents per liter (mEq/L).

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  15. Number of Participants With New Onset Atrial Fibrillation or Flutter

    New onset of atrial fibrillation or flutter is defined as the diagnosis of atrial fibrillation or flutter in a participant after randomization, where atrial fibrillation was not present before randomization.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

  16. Number of Participants With New Onset Diabetes Mellitus (DM)

    The definition of new onset diabetes mellitus is the diagnosis of diabetes mellitus in a participant after randomization, when DM was not present before randomization.

    Measured: Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010), 59.5 months (complete DB phase: 18 March 2011)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2005 (estimated)
  2. Study startMar 2006
  3. Primary completionMay 2010
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00232180
Sponsor's protocol ID
A6141079
Acronym
EMPHASIS-HF
Status last verified
Dec 2020
First submitted
30 Sep 2005
Last updated
22 Dec 2020
Data monitoring committee
Yes

Publications

  • Matsumoto S, Kondo T, Jhund PS, Campbell RT, Swedberg K, van Veldhuisen DJ, Pocock SJ, Pitt B, Zannad F, McMurray JJV. Underutilization of Mineralocorticoid Antagonists in Patients With Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2023 Sep 12;82(11):1080-1091. doi: 10.1016/j.jacc.2023.06.021.

    PubMed 37642608

  • 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.

    PubMed 35867859

  • 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.

    PubMed 35021200

  • 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.

    PubMed 34129365

  • 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.

    PubMed 33893561

  • 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.

    PubMed 33107592

  • 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.

    PubMed 31584516

  • 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.

    PubMed 31072582

  • 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.

    PubMed 29997240

  • 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.

    PubMed 24297687

  • 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.

    PubMed 23810881

  • 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.

    PubMed 23625945

  • 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.

    PubMed 23042980

  • 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.

    PubMed 21073363

  • 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.

    PubMed 20388647

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eplerenone in people with Heart Failure, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 307 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 307 sites in United States, Germany, Ukraine, United Kingdom, France and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00232180, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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