ClinConnect ClinConnect Logo
Search / Trial NCT03057977

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.

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

0 patients applied

Trial Officials

Boehringer Ingelheim

Study Chair

Boehringer Ingelheim

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials