EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
Launched by BOEHRINGER INGELHEIM · Feb 16, 2017
Trial Information
Current as of June 15, 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 preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) \> 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) \> 300 pg/ml for patients without AF, OR \> 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
- • Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
- • Stable dose of oral diuretics, if prescribed
- • 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 (Heart Failure)
- • 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))cr 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 trial
- • 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 may 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
Boston, Massachusetts, United States
Marshfield, Wisconsin, United States
Adelaide, South Australia, Australia
Manhasset, New York, United States
Sarasota, Florida, United States
Clearwater, Florida, United States
Annapolis, Maryland, United States
Saint Paul, Minnesota, United States
Winnipeg, Manitoba, Canada
Vancouver, British Columbia, Canada
Saskatoon, Saskatchewan, Canada
Galveston, Texas, United States
Boston, Massachusetts, United States
Seattle, Washington, United States
Rozzano (Mi), , Italy
Perth, Western Australia, Australia
Richmond, Virginia, United States
Houston, Texas, United States
Los Angeles, California, United States
San Francisco, California, United States
Stony Brook, New York, United States
Singapore, , Singapore
Singapore, , Singapore
Jacksonville, Florida, United States
Montreal, Quebec, Canada
Birmingham, Alabama, United States
Madrid, , Spain
Woodville South, South Australia, Australia
Miami, Florida, United States
Hamilton, Ontario, Canada
Des Moines, Iowa, United States
Columbia, South Carolina, United States
Hannover, , Germany
La Mesa, California, United States
Saint Louis, Missouri, United States
Bedford Park, South Australia, Australia
Kansas City, Missouri, United States
Tampa, Florida, United States
Asheville, North Carolina, United States
Barcelona, , Spain
London, , United Kingdom
Valencia, , Spain
Germantown, Tennessee, United States
Eindhoven, , Netherlands
Littleton, Colorado, United States
Madrid, , Spain
Sevilla, , Spain
Breda, , Netherlands
Leicester, , United Kingdom
New Lambton Heights, New South Wales, Australia
Edmonton, Alberta, Canada
Amsterdam, , Netherlands
Madrid, , Spain
Valencia, , Spain
Groningen, , Netherlands
Malaga, , Spain
Erfurt, , Germany
Memphis, Tennessee, United States
Dresden, , Germany
Beijing, , China
Heidelberg, , Germany
New Orleans, Louisiana, United States
Tustin, California, United States
Halifax, Nova Scotia, Canada
Barnet, , United Kingdom
Saint Louis, Missouri, United States
Leuven, , Belgium
Worcester, , South Africa
Billings, Montana, United States
Ormond Beach, Florida, United States
Anniston, Alabama, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Oxon Hill, Maryland, United States
Milton, Queensland, Australia
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Brno, , Czechia
Bucuresti, , Romania
Warszawa, , Poland
Dallas, Texas, United States
Busan, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Benevento, , Italy
Burlington, Ontario, Canada
Fort Worth, Texas, United States
Brno, , Czechia
Swansea, , United Kingdom
Huntsville, Alabama, United States
Dendermonde, , Belgium
Santiago De Compostela, , Spain
Dallas, Texas, United States
El Palmar, , Spain
Warendorf, , Germany
Chiefland, Florida, United States
Budapest, , Hungary
Owensboro, Kentucky, United States
Lewiston, Maine, United States
Mainz, , Germany
München, , Germany
Sioux Falls, South Dakota, United States
Regensburg, , Germany
Porto Alegre, , Brazil
Incheon, , Korea, Republic Of
Montreal, Quebec, Canada
Liège, , Belgium
Changchun, , China
Wuhan, , China
New Delhi, , India
Bochum, , Germany
New Delhi, , India
Gent, , Belgium
Homburg, , Germany
Seoul, , Korea, Republic Of
Jena, , Germany
Roma, , Italy
Kanagawa, Yokohama, , Japan
Southport, Queensland, Australia
Berlin, , Germany
Charlotte, North Carolina, United States
Aachen, , Germany
Heerlen, , Netherlands
Epping, Victoria, Australia
Singapore, , Singapore
Ede, , Netherlands
Lanzhou, , China
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
Baja, , Hungary
Sesto San Giovanni (Mi), , Italy
Kumamoto, Yatsushiro, , Japan
Seoul, , Korea, Republic Of
Guadalajara, , Mexico
Beverwijk, , Netherlands
Salem, Virginia, United States
Bloemfontein, , South Africa
Frankston, Victoria, Australia
Tucker, Georgia, United States
Grand Island, Nebraska, United States
Gyeonggi Do, , Korea, Republic Of
Columbus, Georgia, United States
Guangzhou, , China
Rockford, Illinois, United States
Napoli, , Italy
Scarborough, Ontario, Canada
Göttingen, , Germany
New York, New York, United States
Pecs, , Hungary
Shanghai, , China
Arlington Heights, Illinois, United States
South Bend, Indiana, United States
Bossier City, Louisiana, United States
Manalapan, New Jersey, United States
Bronx, New York, United States
Saratoga Springs, New York, United States
Lenoir, North Carolina, United States
Jersey Shore, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Danville, Virginia, United States
Belo Horizonte, , Brazil
Campinas, , Brazil
Passo Fundo, , Brazil
Votuporanga, , Brazil
Oakville, Ontario, Canada
Beijing, , China
Changsha, , China
Guangzhou, , China
Chiba, Matsudo, , Japan
Fukui, Fukui, , Japan
Hokkaido, Sapporo, , Japan
Kyoto, Uji, , Japan
Osaka, Osaka, , Japan
Aguascalientes, , Mexico
Singapore, , Singapore
Doylestown, Pennsylvania, United States
Pisa, , Italy
Majadahonda, , Spain
Baltimore, Maryland, United States
Budapest, , Hungary
Fresno, California, United States
Northridge, California, United States
Spartanburg, South Carolina, United States
Roanoke, Virginia, United States
Brampton, Ontario, Canada
Genk, , Belgium
Berlin, , Germany
Papenburg, , Germany
Wermsdorf, , Germany
Cona (Fe), , Italy
Milano, , Italy
Amsterdam, , Netherlands
Kielce, , Poland
High Wycombe, , United Kingdom
Rosario, , Argentina
Beltsville, Maryland, United States
Orlando, Florida, United States
Miami, Florida, United States
Hasselt, , Belgium
Ribeirao Preto, , Brazil
Aichi, Nagoya, , Japan
Fukuoka, Fukuoka, , Japan
Rock Hill, South Carolina, United States
Haikou, , China
Cheongju Si, , Korea, Republic Of
Bridgewater, New Jersey, United States
Szekesfehervar, , Hungary
Gdansk, , Poland
Charleroi, , Belgium
Newport, , United Kingdom
Jackson, Mississippi, United States
Debrecen, , Hungary
Fort Lauderdale, Florida, United States
Baltimore, Maryland, United States
Petoskey, Michigan, United States
Gastonia, North Carolina, United States
Bahia Blanca, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Bs As, , 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
Campinas, , Brazil
Canoas, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Brossard, Quebec, Canada
Montreal, Quebec, Canada
Xi'an, , China
Marianske Lazne, , Czechia
Budapest, , Hungary
Distrito Federal, , Mexico
Tijuana, , Mexico
Gdansk, , Poland
Gdynia, , Poland
Lodz, , Poland
Oswiecim, , Poland
Rzeszow, , Poland
Staszow, , Poland
Bucuresti, , Romania
Alberton, , South Africa
Cape Town, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Ciudad Autónoma De Bs As, , Argentina
Hyogo, Amagasaki, , Japan
Savannah, Georgia, United States
Ashford, South Australia, Australia
Fullarton, South Australia, Australia
Peterborough, Ontario, Canada
Nyiregyhaza, , Hungary
Meppel, , Netherlands
Green Bay, Wisconsin, United States
Wausau, Wisconsin, United States
Madison, Wisconsin, United States
Richmond, Indiana, United States
Xi'an, Shaanxi, China
Austin, Texas, United States
Cali, , Colombia
Kolkatta, , India
New Delhi, , India
Ehime, Matsuyama, , Japan
Gifu, Ogaki, , Japan
Maastricht, , Netherlands
Elkhart, Indiana, United States
Caba, , Argentina
Corrientes, , Argentina
Campina Grande Do Sul, , Brazil
Sao Jose Do Rio Preto, , Brazil
Sao Paulo, , Brazil
Praha 4, , Czechia
Bielefeld, , Germany
Dortmund, , Germany
Dresden, , Germany
Langen, , Germany
Lüdenscheid, , Germany
Budapest, , Hungary
Nasik, , India
Bergamo, , Italy
Hyogo, Himeji, , Japan
Ishikawa, Kanazawa, , Japan
Kagawa, Takamatsu, , Japan
Rosedale, New York, United States
Amsterdam, , Netherlands
Daejeon, , Korea, Republic Of
Las Vegas, Nevada, United States
Saint Louis, Missouri, United States
Cordoba, , Argentina
Shenyang, , China
Fukuoka, Chikushino, , Japan
Fukuoka, Fukuoka, , Japan
Fukuoka, Kitakyushu, , Japan
Kumamoto, Kumamoto, , Japan
Miyagi, Sendai, , Japan
Osaka, Higashiosaka, , Japan
Nuevo Leon, , Mexico
Manizales, , Colombia
Ehime, Matsuyama, , Japan
Hokkaido, Sapporo, , Japan
México, , Mexico
Cape Town, , South Africa
Torun, , Poland
Quebec, , Canada
Gilly, , Belgium
La Louvière, , Belgium
Brno, , Czechia
Geelong, Victoria, Australia
Barcelona, , Spain
Almelo, , Netherlands
Fukuoka, Fukuoka, , Japan
Cali, , Colombia
Brno, , Czechia
Nagykanizsa, , Hungary
Wroclaw, , Poland
Nanjing, , China
Chicago, Illinois, United States
Budapest, , Hungary
North Chicago, Illinois, United States
Bialystok, , Poland
Zutphen, , Netherlands
Bialystok, , Poland
Bydgoszcz, , Poland
Yueyang, , China
Zhenjiang, , China
Naperville, Illinois, United States
Roma, , Italy
Dongguan, , China
Yanji, , China
Bekescsaba, , Hungary
Wuppertal, , Germany
Marion, Ohio, United States
Essen, , Germany
Cheektowaga, New York, United States
La Mesa, California, 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
Deland, Florida, United States
Safety Harbor, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Lawrenceville, Georgia, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Monroe, Louisiana, United States
Great Barrington, Massachusetts, United States
Alpena, Michigan, United States
Bozeman, Montana, United States
Papillion, Nebraska, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Bronx, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Southampton, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Johnstown, Pennsylvania, United States
York, Pennsylvania, United States
Charleston, South Carolina, United States
Jackson, Tennessee, United States
Houston, Texas, United States
Katy, Texas, United States
Plano, Texas, United States
Farmington, Utah, United States
Chester, Virginia, United States
Manassas, Virginia, United States
Richmond, Virginia, United States
Bahia Blanca, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Buenosaires, , Argentina
Ciudadela, , Argentina
Cordoba, , Argentina
Coronel Suarez, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Córdoba, , Argentina
Mar Del Plata, , Argentina
Rosario, , Argentina
Salta, , Argentina
San Martin, , Argentina
San Miguel De Tucuman, , Argentina
San Miguel De Tucuman, , Argentina
Santa Fé, , Argentina
Vicente Lopez, , Argentina
Villa Luro, , Argentina
Kotara, New South Wales, Australia
Bela Vista, , Brazil
Belo Horizonte, , Brazil
Brasília, , Brazil
Brasília, , Brazil
Brasília, , Brazil
Campinas, , Brazil
Caxias Do Sul, , Brazil
Curitiba, , Brazil
Goiânia, , Brazil
Goiânia, , Brazil
Marília, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
Rio De Janeiro, , Brazil
Santa Efigenia, , 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
North Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Moncton, New Brunswick, Canada
Brampton, Ontario, Canada
Cambridge, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Scarborough, Ontario, Canada
Sudbury, 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
Barranquilla, , Colombia
Barranquilla, , Colombia
Barranquilla, , Colombia
Bogota D.C, , Colombia
Bogota, , Colombia
Cali, , Colombia
Cartagena, , Colombia
Cartagena, , Colombia
Floridablanca, , Colombia
Medellin, , Colombia
Bilovec, , Czechia
Brno, , Czechia
Brno, , Czechia
Brno, , Czechia
Broumov, , Czechia
Chrudim, , Czechia
Frydek Mistek, , Czechia
Havlickuv Brod, , Czechia
Hradec Kralove, , Czechia
Louny, , Czechia
Olomouc, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Praha 2, , Czechia
Praha 4 Krc, , Czechia
Praha 5, , Czechia
Prerov, , Czechia
Trebic, , Czechia
Tremosna, , Czechia
Trutnov, , Czechia
Uherske Hradiste, , Czechia
Unicov, , Czechia
Zlin, , Czechia
Znojmo, , Czechia
Dessau Roßlau, , Germany
Frankfurt, , Germany
Lüneburg, , Germany
Mannheim, , Germany
Nürnberg, , Germany
Riesa, , Germany
Wangen Im Allgäu, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Gyongyos, , Hungary
Kalocsa, , Hungary
Komarom, , Hungary
Oroshaza, , Hungary
Pecs, , Hungary
Veszprem, , Hungary
Ahmedabad, , India
Aurangabad, , India
Bangalore, , India
Bengaluru, , India
Chennai, , India
Chennai, , India
Gurgaon, , India
Guwahati, , India
Nashik, , India
New Delhi, , India
Cortona, , Italy
Milano, , Italy
Trieste, , Italy
Aichi, Kasugai, , Japan
Chiba, Chiba, , Japan
Chiba, Kisarazu, , Japan
Ehime, Uwajima, , Japan
Fukuoka, Chikushino, , Japan
Fukuoka, Kitakyushu, , Japan
Fukushima, Shirakawa, , Japan
Gifu, Seki, , Japan
Hiroshima, Fukuyama, , Japan
Hiroshima, Shobara, , Japan
Hokkaido, Tomakomai, , Japan
Hokkaido,Otaru, , Japan
Hyogo, Kobe, , Japan
Ibaraki, Higashiibaraki Gun, , Japan
Ibaraki, Koga, , Japan
Kagawa, Kanonji, , Japan
Kanagawa, Kawasaki, , Japan
Kanagawa, Sagamihara, , Japan
Kumamoto, Kumamoto, , Japan
Kusatsu, , Japan
Miyagi, Sendai, , Japan
Miyagi, Sendai, , Japan
Miyazaki, Miyazaki, , Japan
Nagano, Nakano, , Japan
Nagasaki, Omura, , Japan
Oita, Oita, , 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
Wonju Si, , Korea, Republic Of
Guadalajara, , Mexico
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
Rotterdam, , Netherlands
Zaandam, , Netherlands
Bialystok, , Poland
Bielsko Biala, , Poland
Chorzow, , Poland
Dabrowa Gornicza, , Poland
Gdynia, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Lowicz, , Poland
Nysa, , Poland
Piaseczno, , Poland
Ruda Slaska, , Poland
Siedlce, , Poland
Skierniewice, , Poland
Tychy, , Poland
Ustron, , Poland
Warszawa, , Poland
Zgierz, , Poland
Zychlin, , Poland
Balotesti, , Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucuresti, , Romania
Craiova, , Romania
Deva, , Romania
Timisoara, , Romania
Timisoara, , Romania
Bloemfontein, , South Africa
Cape Town, , South Africa
George, , South Africa
Johannesburg, , South Africa
Johannesburg, , South Africa
Kempton Park, , South Africa
Somerset West, , South Africa
Cardiff, , United Kingdom
Eastleigh, , United Kingdom
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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