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
NCT ID: NCT00232180
Last Updated: 2020-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2743 participants
INTERVENTIONAL
2006-03-31
2012-01-31
Brief Summary
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The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.
On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Eplerenone arm
Eplerenone administered on top of background standard heart failure therapy
Eplerenone
Eplerenone administered on top of background standard heart failure therapy
Interventions
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Eplerenone
Eplerenone administered on top of background standard heart failure therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
55 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Levice, , Slovakia
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Phoenix, Arizona, United States
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Loma Linda, California, United States
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Merced, California, United States
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Stockton, California, United States
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Colorado Springs, Colorado, United States
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Bridgeport, Connecticut, United States
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Hartford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Daytona Beach, Florida, United States
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Gainesville, Florida, United States
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Jupiter, Florida, United States
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Melbourne, Florida, United States
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Rockford, Illinois, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Bangor, Maine, United States
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Annapolis, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Minneapolis, Minnesota, United States
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MN, Minnesota, United States
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Tupelo, Mississippi, United States
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Tupelo, Mississippi, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Omaha, Nebraska, United States
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Manchester, New Hampshire, United States
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Albany, New York, United States
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Rochester, New York, United States
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Rochester, New York, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Beaver, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Leetsdale, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Cumberland, Rhode Island, United States
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Germantown, Tennessee, United States
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Knoxville, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Plano, Texas, United States
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Spokane, Washington, United States
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Madison, Wisconsin, United States
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Morón, Pcia. de Buenos Aires, Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Concord, New South Wales, Australia
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Brisbane, Queensland, Australia
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Launceston, Tasmania, Australia
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Antwerp, , Belgium
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Bonheiden, , Belgium
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Eupen, , Belgium
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Genk, , Belgium
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Hasselt, , Belgium
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Huy, , Belgium
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La Louvière, , Belgium
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Lanaken, , Belgium
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Leuven, , Belgium
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Overpelt, , Belgium
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Yvoir, , Belgium
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Hamilton, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Sherbrooke, Quebec, Canada
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St-georges (Beauce), Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Ostrava, , Czechia
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Pilsen, , Czechia
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Toulouse, Cedex 4, France
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Angers, , France
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Brest, , France
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Valenciennes, , France
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Bad Nauheim, , Germany
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Bad Rothenfelde, , Germany
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Cologne, , Germany
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Essen, , Germany
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Frankfurt am Main, , Germany
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Göttingen, , Germany
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Hagen, , Germany
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Halle, , Germany
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Hanover, , Germany
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Homburg/Saar, , Germany
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Leipzig, , Germany
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Ludwigshafen, , Germany
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Lübeck, , Germany
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Athens, Attica, Greece
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Haidari, Attica, Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Chai Wan, , Hong Kong
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Pokfulam, , Hong Kong
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Shatin NT, , Hong Kong
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Mosonmagyaróvár, , Hungary
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Siófok, , Hungary
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Szeged, , Hungary
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Hyderabad, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Pune, Maharshtra, India
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Ludhiana, Punjab, India
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Chennai, Tamil Nadu, India
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Coimbatore, Tamil Nadu, India
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Lucknow, Uttar Pradesh, India
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Cork, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Bergamo (BG), , Italy
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Catania, , Italy
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Catania, , Italy
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Florence, , Italy
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Mestre - Zelardino (VE), , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Roma, , Italy
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Sassari, , Italy
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Trieste, , Italy
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Venezia, , Italy
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Aguascalientes, Aguacalientes, Mexico
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Guadalajara, Jalisco, Mexico
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Zapopan, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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San Luis Potosí City, , Mexico
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's-Hertogenbosch, , Netherlands
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Alkmaar, , Netherlands
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Apeldoorn, , Netherlands
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Apeldoorn, , Netherlands
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Arnhem, , Netherlands
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Deventer, , Netherlands
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Veldhoven, , Netherlands
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Velp, , Netherlands
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Zwolle, , Netherlands
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Piotrkow Trybunalski, , Poland
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Poznan, , Poland
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Stalowa Wola, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Guilhufe - PNF, Penafiel, Portugal
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Almada, , Portugal
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Amadora, , Portugal
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Coimbra, , Portugal
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Linda a Velha, , Portugal
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Lisbon, , Portugal
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Oliveira de Azeméis, , Portugal
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Portalegre, , Portugal
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Porto, , Portugal
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Vila Franca de Xira, , Portugal
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Vila Real, , Portugal
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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S-Petersburg, , Russia
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S-Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Singapore, , Singapore
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Singapore, , Singapore
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Liptovský Mikuláš, , Slovakia
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Nitra, , Slovakia
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Trenčín, , Slovakia
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Soweto, Johannesburg, South Africa
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Bloemfontein, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Johannesburg, , South Africa
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KwaKhangela, , South Africa
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Kwazulu Natal, , South Africa
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Republic of Korea, Korea, South Korea
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Suwon, , South Korea
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Taegu, , South Korea
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Santiago de Compostela, LA Coruña, Spain
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Barakaldo, Vizcaya, Spain
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Almería, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Málaga, , Spain
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Ängelholm, , Sweden
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Bollnäs, , Sweden
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Falun, , Sweden
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Halmstad, , Sweden
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Hässleholm, , Sweden
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Lindesberg, , Sweden
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Linköping, , Sweden
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Luleå, , Sweden
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Mölndal, , Sweden
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Skellefteå, , Sweden
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Varberg, , Sweden
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Vaxjo, , Sweden
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Simferopol, Autonomous Republic of Crimea, Ukraine
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Dnipropetrovsk, , Ukraine
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Dnipropetrovsk, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
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Uzhhorod, , Ukraine
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Zaporizhzhia, , Ukraine
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Dubai, UAE, United Arab Emirates
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Abu Dhabi, , United Arab Emirates
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Knutsford, Cheshire, United Kingdom
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Macclesfield, Cheshire, United Kingdom
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Belfast, Northern Ireland, United Kingdom
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Glasgow, Strathclyde, United Kingdom
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Belfast, , United Kingdom
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Coventry, , United Kingdom
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Edinburgh, , United Kingdom
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Glasgow, , United Kingdom
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Glasgow, , United Kingdom
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Harrow, , United Kingdom
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Larbert, , United Kingdom
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Macclesfield, , United Kingdom
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Manchester, , United Kingdom
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Milton Keynes, , United Kingdom
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Sheffield, , United Kingdom
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Southend-on-Sea, , United Kingdom
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Torquay, , United Kingdom
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Caracas, Distrito Federal, Venezuela
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Caracas, Miranda, Venezuela
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Caracas, Miranda, Venezuela
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References
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Butt JH, Solomon SD, Vaduganathan M, van Veldhuisen DJ, Kober L, Pitt B, Zannad F, Jhund PS, McMurray JJV. Mineralocorticoid receptor antagonists in heart failure with reduced ejection fraction according to body weight. Eur J Heart Fail. 2025 Apr 21. doi: 10.1002/ejhf.3665. Online ahead of print.
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.
Vaduganathan M, Ferreira JP, Rossignol P, Neuen BL, Claggett BL, Pfeffer MA, McMurray JJV, Pitt B, Zannad F, Solomon SD. Effects of steroidal mineralocorticoid receptor antagonists on acute and chronic estimated glomerular filtration rate slopes in patients with chronic heart failure. Eur J Heart Fail. 2022 Sep;24(9):1586-1590. doi: 10.1002/ejhf.2635. Epub 2022 Aug 31.
Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WHW, Bohm M, Pitt B, Zannad F, Rossignol P. Prognostic relevance of magnesium alterations in patients with a myocardial infarction and left ventricular dysfunction: insights from the EPHESUS trial. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):148-159. doi: 10.1093/ehjacc/zuab111.
Ferreira JP, Lamiral Z, McMurray JJV, Swedberg K, van Veldhuisen DJ, Vincent J, Rossignol P, Pocock SJ, Pitt B, Zannad F. Impact of Insulin Treatment on the Effect of Eplerenone: Insights From the EMPHASIS-HF Trial. Circ Heart Fail. 2021 Jun;14(6):e008075. doi: 10.1161/CIRCHEARTFAILURE.120.008075. Epub 2021 Jun 15.
Martens P, Ferreira JP, Vincent J, Abreu P, Busselen M, Mullens W, Tang WWH, Bohm M, Pitt B, Zannad F, Rossignol P. Serum sodium and eplerenone use in patients with a myocardial infarction and left ventricular dysfunction or heart failure: insights from the EPHESUS trial. Clin Res Cardiol. 2022 Apr;111(4):380-392. doi: 10.1007/s00392-021-01853-8. Epub 2021 Apr 23.
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Monzo L, Ferreira JP, Abreu P, Szumski A, Bohm M, McMurray JJV, Pitt B, Swedberg K, van Veldhuisen DJ, Girerd N, Vincent J, Zannad F, Rossignol P. Visit-to-visit blood pressure variation and outcomes in heart failure with reduced ejection fraction: findings from the Eplerenone in Patients with Systolic Heart Failure and Mild Symptoms trial. J Hypertens. 2020 Mar;38(3):420-425. doi: 10.1097/HJH.0000000000002275.
Stienen S, Ferreira JP, Vincent J, Busselen M, Li B, McMurray JJV, Pitt B, Girerd N, Rossignol P, Zannad F. Estimated Long-Term Survival With Eplerenone. J Am Coll Cardiol. 2019 May 14;73(18):2357-2359. doi: 10.1016/j.jacc.2019.02.043. No abstract available.
Ferreira JP, Duarte K, McMurray JJV, Pitt B, van Veldhuisen DJ, Vincent J, Ahmad T, Tromp J, Rossignol P, Zannad F. Data-Driven Approach to Identify Subgroups of Heart Failure With Reduced Ejection Fraction Patients With Different Prognoses and Aldosterone Antagonist Response Patterns. Circ Heart Fail. 2018 Jul;11(7):e004926. doi: 10.1161/CIRCHEARTFAILURE.118.004926.
Rossignol P, Dobre D, McMurray JJ, Swedberg K, Krum H, van Veldhuisen DJ, Shi H, Messig M, Vincent J, Girerd N, Bakris G, Pitt B, Zannad F. Incidence, determinants, and prognostic significance of hyperkalemia and worsening renal function in patients with heart failure receiving the mineralocorticoid receptor antagonist eplerenone or placebo in addition to optimal medical therapy: results from the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure (EMPHASIS-HF). Circ Heart Fail. 2014 Jan;7(1):51-8. doi: 10.1161/CIRCHEARTFAILURE.113.000792. Epub 2013 Dec 2.
Eschalier R, McMurray JJ, Swedberg K, van Veldhuisen DJ, Krum H, Pocock SJ, Shi H, Vincent J, Rossignol P, Zannad F, Pitt B; EMPHASIS-HF Investigators. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013 Oct 22;62(17):1585-93. doi: 10.1016/j.jacc.2013.04.086. Epub 2013 Jun 27.
Krum H, Shi H, Pitt B, McMurray J, Swedberg K, van Veldhuisen DJ, Vincent J, Pocock S, Zannad F; EMPHASIS-HF Study Group. Clinical benefit of eplerenone in patients with mild symptoms of systolic heart failure already receiving optimal best practice background drug therapy: analysis of the EMPHASIS-HF study. Circ Heart Fail. 2013 Jul;6(4):711-8. doi: 10.1161/CIRCHEARTFAILURE.112.000173. Epub 2013 Apr 26.
Rogers JK, McMurray JJ, Pocock SJ, Zannad F, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms: analysis of repeat hospitalizations. Circulation. 2012 Nov 6;126(19):2317-23. doi: 10.1161/CIRCULATIONAHA.112.110536. Epub 2012 Oct 5.
Zannad F, McMurray JJ, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011 Jan 6;364(1):11-21. doi: 10.1056/NEJMoa1009492. Epub 2010 Nov 14.
Zannad F, McMurray JJ, Drexler H, Krum H, van Veldhuisen DJ, Swedberg K, Shi H, Vincent J, Pitt B. Rationale and design of the Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure (EMPHASIS-HF). Eur J Heart Fail. 2010 Jun;12(6):617-22. doi: 10.1093/eurjhf/hfq049. Epub 2010 Apr 13.
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Other Identifiers
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A6141079
Identifier Type: -
Identifier Source: org_study_id
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