EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)
Launched by BOEHRINGER INGELHEIM · Feb 16, 2017
Trial Information
Current as of August 11, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Male or female patient age \>= 18 years at screening. For Japan only: Age \>= 20 years at screening
- • Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) \<=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
- • If EF \>= 36% to \<= 40%: NT-proBNP \>= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP \>= 5000 pg/ml for patients with AF
- • If EF \>= 31% to \<= 35%: NT-proBNP \>= 1000 pg/ml for patients without AF and NT-proBNP \>=2000 pg/ml for patients with AF
- • If EF\<= 30%: NT-proBNP \>= 600 pg/ml for patients without AF and NT-proBNP \>=1200 pg/ml for patients with AF
- • EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP \>= 1200 pg/ml for patients with AF
- • Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
- • Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
- • Signed and dated written ICF (Informed Consent Form)
- • Further inclusion criteria apply
- Exclusion criteria:
- • Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
- • Heart transplant recipient, or listed for heart transplant
- • Acute decompensated HF
- • Systolic blood pressure (SBP) \>= 180 mmHg at Visit 2.
- • Symptomatic hypotension and/or a SBP \< 100 mmHg
- • Indication of liver disease
- • Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) \< 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
- • History of ketoacidosis
- • Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
- • Currently enrolled in another investigational device or drug study
- • Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
- • Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- • Further exclusion criteria apply
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Marshfield, Wisconsin, United States
Durham, North Carolina, United States
Chicago, Illinois, United States
Sudbury, Ontario, Canada
Sarasota, Florida, United States
Parkville, Victoria, Australia
Madrid, , Spain
Clearwater, Florida, United States
Annapolis, Maryland, United States
Saint Paul, Minnesota, United States
Winnipeg, Manitoba, Canada
Vancouver, British Columbia, Canada
Toledo, Ohio, United States
Boston, Massachusetts, United States
Richmond, Virginia, United States
Houston, Texas, United States
Los Angeles, California, United States
Fort Lauderdale, Florida, United States
Stony Brook, New York, United States
Jacksonville, Florida, United States
Madrid, , Spain
New Orleans, Louisiana, United States
Miami, Florida, United States
Hamilton, Ontario, Canada
Vancouver, British Columbia, Canada
Columbia, South Carolina, United States
Hannover, , Germany
La Mesa, California, United States
Saint Louis, Missouri, United States
Asheville, North Carolina, United States
Barcelona, , Spain
London, , United Kingdom
New York, New York, United States
Madrid, , Spain
L'hospitalet De Llobregat, , Spain
Durham, North Carolina, United States
Eindhoven, , Netherlands
Littleton, Colorado, United States
Madrid, , Spain
Breda, , Netherlands
Leicester, , United Kingdom
New Lambton Heights, New South Wales, Australia
Edmonton, Alberta, Canada
Amsterdam, , Netherlands
Valladolid, , Spain
Groningen, , Netherlands
Malaga, , Spain
Erfurt, , Germany
Memphis, Tennessee, United States
Beijing, , China
Heidelberg, , Germany
Tustin, California, United States
Pau, , France
Halifax, Nova Scotia, Canada
Barnet, , United Kingdom
Leuven, , Belgium
Augusta, Georgia, United States
Ormond Beach, Florida, United States
Deland, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Milton, Queensland, Australia
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Fitzroy, Victoria, Australia
Dallas, Texas, United States
Busan, , Korea, Republic Of
Benevento, , Italy
Burlington, Ontario, Canada
Fort Worth, Texas, United States
Swansea, , United Kingdom
Dendermonde, , Belgium
Crystal River, Florida, United States
Santiago De Compostela, , Spain
Dallas, Texas, United States
El Palmar, , Spain
Warendorf, , Germany
Budapest, , Hungary
Charleston, South Carolina, United States
Owensboro, Kentucky, United States
Hamburg, , Germany
München, , Germany
Regensburg, , Germany
Porto Alegre, , Brazil
Incheon, , Korea, Republic Of
Montreal, Quebec, Canada
Changchun, , China
Wuhan, , China
Mainz, , Germany
New Delhi, , India
New Delhi, , India
Homburg, , Germany
Seoul, , Korea, Republic Of
Jena, , Germany
Roma, , Italy
Kanagawa, Yokohama, , Japan
Cheongju, , Korea, Republic Of
Columbia, South Carolina, United States
Berlin, , Germany
Charlotte, North Carolina, United States
Prague 2, , Czechia
Aachen, , Germany
Heerlen, , Netherlands
Epping, Victoria, Australia
Ede, , Netherlands
Maastricht, , Netherlands
Lanzhou, , China
Montpellier, , France
Nieuwegein, , Netherlands
Wuhan, , China
Busan, , Korea, Republic Of
Kiel, , Germany
Long Beach, California, United States
Burlington, North Carolina, United States
Caba, , Argentina
San Miguel De Tucumán, , Argentina
Porto Alegre, , Brazil
Cambridge, Ontario, Canada
Berlin, , Germany
Dresden, , Germany
Baja, , Hungary
Kumamoto, Yatsushiro, , Japan
Seoul, , Korea, Republic Of
Guadalajara, , Mexico
Beverwijk, , Netherlands
Hoorn, , Netherlands
Salem, Virginia, United States
Columbus, Georgia, United States
Guangzhou, , China
Rockford, Illinois, United States
Napoli, , Italy
Scarborough, Ontario, Canada
Göttingen, , Germany
New York, New York, United States
Shanghai, , China
Arlington Heights, Illinois, United States
South Bend, Indiana, United States
Alexandria, Louisiana, United States
Bronx, New York, United States
Lenoir, North Carolina, United States
Anderson, South Carolina, United States
Dallas, Texas, United States
Belo Horizonte, , Brazil
Campina Grande Do Sul, , Brazil
Campinas, , Brazil
Goiania, , Brazil
Passo Fundo, , Brazil
Votuporanga, , Brazil
Oakville, Ontario, Canada
Beijing, , China
Changsha, , China
Guangzhou, , China
Chiba, Matsudo, , Japan
Fukui, Fukui, , Japan
Fukuoka, Iizuka, , Japan
Kyoto, Uji, , Japan
Osaka, Osaka, , Japan
Aguascalientes, , Mexico
Doylestown, Pennsylvania, United States
Caen, , France
Pisa, , Italy
Baltimore, Maryland, United States
Spartanburg, South Carolina, United States
Roanoke, Virginia, United States
Genk, , Belgium
Toulouse, , France
Berlin, , Germany
Papenburg, , Germany
Cona (Fe), , Italy
Milano, , Italy
Roma, , Italy
Amsterdam, , Netherlands
Kielce, , Poland
High Wycombe, , United Kingdom
Luton, , United Kingdom
Rosario, , Argentina
Beltsville, Maryland, United States
Hasselt, , Belgium
Aichi, Nagoya, , Japan
Fukuoka, Fukuoka, , Japan
Rock Hill, South Carolina, United States
Haikou, , China
Bridgewater, New Jersey, United States
Szekesfehervar, , Hungary
Gdansk, , Poland
Charleroi, , Belgium
Newport, , United Kingdom
Fort Lauderdale, Florida, United States
Gastonia, North Carolina, United States
Bahia Blanca, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Bs As, , Argentina
Cordoba, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Mar Del Plata, , Argentina
Quilmes, , Argentina
Quilmes, , Argentina
Rosario, , Argentina
Rosario, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Vicente, , Argentina
Santa Fe, , Argentina
Santa Fé, , Argentina
Campinas, , Brazil
Canoas, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Sao Jose Do Rio Preto, , Brazil
Montreal, Quebec, Canada
Xi'an, , China
Praha 4 Krc, , Czechia
Budapest, , Hungary
Wonju, , Korea, Republic Of
Distrito Federal, , Mexico
Tijuana, , Mexico
Zapopan, , Mexico
Gdansk, , Poland
Gdynia, , Poland
Lodz, , Poland
Oswiecim, , Poland
Rzeszow, , Poland
Staszow, , Poland
Barcelona, , Spain
Ciudad Autónoma De Bs As, , Argentina
Mechelen, , Belgium
Hyogo, Amagasaki, , Japan
Savannah, Georgia, United States
Pessac, , France
Fullarton, South Australia, Australia
Peterborough, Ontario, Canada
Meppel, , Netherlands
Richmond, Indiana, United States
Xi'an, Shaanxi, China
Kolkatta, , India
New Delhi, , India
Ehime, Matsuyama, , Japan
Gifu, Ogaki, , Japan
Gdynia, , Poland
Besançon, , France
Great Neck, New York, United States
South Brisbane, Queensland, Australia
Elkhart, Indiana, United States
Caba, , Argentina
Corrientes, , Argentina
Gent, , Belgium
Sao Paulo, , Brazil
Bielefeld, , Germany
Dortmund, , Germany
Dresden, , Germany
Langen, , Germany
Lüdenscheid, , Germany
Budapest, , Hungary
Budapest, , Hungary
Nasik, , India
Bergamo, , Italy
Hyogo, Himeji, , Japan
Ishikawa, Kanazawa, , Japan
Kagawa, Takamatsu, , Japan
Shiga, Kusatsu, , Japan
Ciudad De Mexico, , Mexico
Uden, , Netherlands
Warsaw, , Poland
Amsterdam, , Netherlands
Daejeon, , Korea, Republic Of
Las Vegas, Nevada, United States
Cordoba, , Argentina
Brugge, , Belgium
Shenyang, , China
Aichi, Toyota, , Japan
Fukuoka, Chikushino, , Japan
Fukuoka, Fukuoka, , Japan
Fukuoka, Kitakyushu, , Japan
Kumamoto, Kumamoto, , Japan
Miyagi, Sendai, , Japan
Osaka, Higashiosaka, , Japan
Nuevo Leon, , Mexico
Ehime, Matsuyama, , Japan
Hokkaido, Sapporo, , Japan
México, , Mexico
Paris, , France
Rosario, , Argentina
Torun, , Poland
Orense, , Spain
Quebec, , Canada
Gilly, , Belgium
La Louvière, , Belgium
Brno, , Czechia
Lodz, , Poland
Geelong, Victoria, Australia
Aichi, Nagoya, , Japan
Almelo, , Netherlands
Covington, Louisiana, United States
Fukuoka, Fukuoka, , Japan
Brno, , Czechia
Louny, , Czechia
Nagykanizsa, , Hungary
Wroclaw, , Poland
Nanjing, , China
Budapest, , Hungary
Warszawa, , Poland
North Chicago, Illinois, United States
Zutphen, , Netherlands
Bialystok, , Poland
Bydgoszcz, , Poland
Yueyang, , China
Zhenjiang, , China
Dongguan, , China
Yanji, , China
Bekescsaba, , Hungary
Bron, , France
Wuppertal, , Germany
Marion, Ohio, United States
Essen, , Germany
Cheektowaga, New York, United States
Merced, California, United States
Orange, California, United States
Riverside, California, United States
Torrance, California, United States
Vista, California, United States
Boca Raton, Florida, United States
Atlanta, Georgia, United States
Lawrenceville, Georgia, United States
Indianapolis, Indiana, United States
Monroe, Louisiana, United States
Great Barrington, Massachusetts, United States
Alpena, Michigan, United States
Chapel Hill, North Carolina, United States
Oklahoma City, Oklahoma, United States
York, Pennsylvania, United States
Farmington, Utah, United States
Chester, Virginia, United States
Bahia Blanca, , Argentina
Ciudadela, , Argentina
Coronel Suarez, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Mar Del Plata, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Martin, , Argentina
Villa Luro, , Argentina
Belo Horizonte, , Brazil
Brasília, , Brazil
Brasília, , Brazil
Campinas, , Brazil
Caxias Do Sul, , Brazil
Curitiba, , Brazil
Goiânia, , Brazil
Marília, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Santo André, , Brazil
Santo André, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
São Bernardo Do Campo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Vitória, , Brazil
Victoria, British Columbia, Canada
Moncton, New Brunswick, Canada
Brampton, Ontario, Canada
Hamilton, Ontario, Canada
Scarborough, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Waterloo, Ontario, Canada
York, Ontario, Canada
Greenfield Park, Quebec, Canada
Longeuil, Quebec, Canada
Montreal, Quebec, Canada
Changsha, , China
Changsha, , China
Fuzhou, , China
Haikou, , China
Lanzhou, , China
Luzhou, , China
Nanchang, , China
Shenyang, , China
Tianjin, , China
Bilovec, , Czechia
Brno, , Czechia
Brno, , Czechia
Broumov, , Czechia
Chrudim, , Czechia
Olomouc, , Czechia
Pardubice, , Czechia
Prerov, , Czechia
Zlin, , Czechia
Znojmo, , Czechia
Dessau Roßlau, , Germany
Frankfurt, , Germany
Lüneburg, , Germany
Riesa, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Gyongyos, , Hungary
Komarom, , Hungary
Oroshaza, , Hungary
Veszprem, , Hungary
Ahmedabad, , India
Aurangabad, , India
Bangalore, , India
Bengaluru, , India
Chennai, , India
Chennai, , India
Gurgaon, , India
Nashik, , India
New Delhi, , India
Trieste, , Italy
Aichi, Kasugai, , Japan
Chiba, Chiba, , Japan
Chiba, Kisarazu, , Japan
Ehime, Uwajima, , Japan
Fukuoka, Chikushino, , Japan
Fukuoka, Kitakyushu, , Japan
Gifu, Seki, , Japan
Hiroshima, Fukuyama, , Japan
Hiroshima, Shobara, , Japan
Hokkaido, Tomakomai, , Japan
Hyogo, Kobe, , Japan
Ibaraki, Higashiibaraki Gun, , Japan
Kagawa, Kanonji, , Japan
Kanagawa, Sagamihara, , Japan
Kumamoto, Kumamoto, , Japan
Miyagi, Sendai, , Japan
Miyagi, Sendai, , Japan
Miyazaki, Miyazaki, , Japan
Nagano, Nakano, , Japan
Nagasaki, Omura, , Japan
Okayama, Okayama, , Japan
Okinawa, Naha, , Japan
Okinawa, Shimajiri Gun, , Japan
Okinawa, Urasoe, , Japan
Osaka, Osaka, , Japan
Osaka, Takatsuki, , Japan
Saitama, Saitama, , Japan
Saitama, Saitama, , Japan
Tokushima, Tokushima, , Japan
Tokyo, Meguro Ku, , Japan
Tokyo, Ome, , Japan
Tokyo, Ota Ku, , Japan
Tokyo, Toshima Ku, , Japan
Wakayama, Tanabe, , Japan
Yamaguchi, Shimonoseki, , Japan
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico, , Mexico
Monclova, , Mexico
San Juan Del Rio, , Mexico
San Luis Potosi, , Mexico
Torreon, , Mexico
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Blaricum, , Netherlands
Nijmegen, , Netherlands
Zaandam, , Netherlands
Bialystok, , Poland
Bielsko Biala, , Poland
Chorzow, , Poland
Dabrowa Gornicza, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lowicz, , Poland
Nysa, , Poland
Ruda Slaska, , Poland
Siedlce, , Poland
Tychy, , Poland
Ustron, , Poland
Zgierz, , Poland
Zychlin, , Poland
Cardiff, , United Kingdom
Eastleigh, , United Kingdom
Pensacola, Florida, United States
Baltimore, Maryland, United States
Towson, Maryland, United States
Saint Louis, Missouri, United States
Lake Success, New York, United States
Plano, Texas, United States
Olivos, , Argentina
San Miguel De Tucumán, , Argentina
Tucumán, , Argentina
Ashford, South Australia, Australia
Belo Horizonte, , Brazil
Brasília, , Brazil
Fortaleza, , Brazil
Ribeirão Preto, , Brazil
Rio De Janeiro Rj, , Brazil
Sao Paulo, , Brazil
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Saint George De Beauce, Quebec, Canada
Brandys Nad, , Czechia
Frydek Mistek, , Czechia
Prag 5, , Czechia
Pribram, , Czechia
Trebic, , Czechia
Usti Nad Labem, , Czechia
Bayonne, , France
Vandoeuvre Lès Nancy, , France
Nienburg, , Germany
Wangen, , Germany
Pecs, , Hungary
Pécs, , Hungary
Cortona (Ar), , Italy
Hiroshima, Hatsukaichi, , Japan
Hokkaido, Hakodate, , Japan
Miyagi, Sendai, , Japan
Osaka, Sakai, , Japan
Sungnam, , Korea, Republic Of
Den Haag, , Netherlands
Venlo, , Netherlands
Skierniewice, , Poland
Patients applied
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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