Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
Launched by ASTRAZENECA · Jan 26, 2017
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect Summary
This is an international, multicentre, parallel group, event-driven, randomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once daily in addition to background regional standard of care therapy, for the prevention of cardiovascular (CV) death or reduction of heart failure (HF) events.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Provision of signed informed consent prior to any study specific procedures
- • Male or female, aged ≥18 years
- • Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
- • LVEF≤40%
- • Elevated NT-proBNP levels
- • Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
- • eGFR ≥30 mL/min/1.73 m\^2 (CKD-EPI formula) at enrolment (visit 1)
- Exclusion Criteria:
- • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- • Type 1 diabetes mellitus
- • Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
- • Current acute decompensated HF or hospitalization due to decompensated HF \<4 weeks prior to enrolment
- • MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
- • Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
- • Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
- • Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
- • HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
- • Symptomatic bradycardia or second or third degree heart block without a pacemaker
- • Severe (eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Altoona, Pennsylvania, United States
Stockton, California, United States
Port Charlotte, Florida, United States
Jacksonville, Florida, United States
Blagoevgrad, , Bulgaria
Kazan, , Russian Federation
Székesfehérvár, , Hungary
Pune, , India
Dallas, Texas, United States
Minneapolis, Minnesota, United States
Haskovo, , Bulgaria
Columbus, Ohio, United States
Omaha, Nebraska, United States
Bakersfield, California, United States
Las Vegas, Nevada, United States
Nijmegen, , Netherlands
Plovdiv, , Bulgaria
Praha 4, , Czechia
Dundee, , United Kingdom
Philadelphia, Pennsylvania, United States
Berlin, , Germany
Budapest, , Hungary
Torun, , Poland
Cottingham, , United Kingdom
Edinburgh, , United Kingdom
Buffalo, New York, United States
Pittsburgh, Pennsylvania, United States
Alexandria, Louisiana, United States
Mobile, Alabama, United States
Los Angeles, California, United States
Haverhill, Massachusetts, United States
Lansing, Michigan, United States
Kansas City, Missouri, United States
Grand Island, Nebraska, United States
Lincoln, Nebraska, United States
Cortlandt Manor, New York, United States
New York, New York, United States
Burlington, North Carolina, United States
Memphis, Tennessee, United States
Tullahoma, Tennessee, United States
Beaumont, Texas, United States
Corrientes, , Argentina
Rio De Janeiro, , Brazil
Dimitrovgrad, , Bulgaria
Pleven, , Bulgaria
Sofia, , Bulgaria
Hamilton, Ontario, Canada
London, Ontario, Canada
Benesov, , Czechia
Hellerup, , Denmark
Herlev, , Denmark
Hvidovre, , Denmark
Mainz, , Germany
Zalaegerszeg, , Hungary
Groningen, , Netherlands
Rotterdam, , Netherlands
Gdynia, , Poland
Moscow, , Russian Federation
Lucenec, , Slovakia
Presov, , Slovakia
Richmond, Virginia, United States
Vista, California, United States
New Brunswick, New Jersey, United States
Boston, Massachusetts, United States
Nashville, Tennessee, United States
Saint John, New Brunswick, Canada
Brno, , Czechia
Kassel, , Germany
Wermsdorf, , Germany
Gouda, , Netherlands
Nottingham, , United Kingdom
Great Falls, Montana, United States
Beverly Hills, California, United States
Atlanta, Georgia, United States
Taichung, , Taiwan
Kecskemét, , Hungary
Hcmc, , Vietnam
Pembroke Pines, Florida, United States
Seattle, Washington, United States
Naples, Florida, United States
Poughkeepsie, New York, United States
Palm Springs, California, United States
Lake Worth, Florida, United States
Tupelo, Mississippi, United States
Tyler, Texas, United States
Buenos Aires, , Argentina
Saint Jerome, Quebec, Canada
Beijing, , China
Shanghai, , China
Tainan, , Taiwan
Legnica, , Poland
Kosice, , Slovakia
Sao Paulo, , Brazil
Calgary, Alberta, Canada
Louisville, Kentucky, United States
Taipei, , Taiwan
Torrance, California, United States
Columbia, Maryland, United States
Trebisov, , Slovakia
Boynton Beach, Florida, United States
Rosedale, New York, United States
Rapid City, South Dakota, United States
Knoxville, Tennessee, United States
San Miguel De Tucuman, , Argentina
Brasilia, , Brazil
Curitiba, , Brazil
New Westminster, British Columbia, Canada
Cambridge, Ontario, Canada
Guangzhou, , China
Yinchuan, , China
Bad Oeynhausen, , Germany
Szentes, , Hungary
Płock, , Poland
Saint Petersburg, , Russian Federation
Zilina, , Slovakia
Kaohsiung, , Taiwan
Kweishan Shiang, , Taiwan
Inverness, , United Kingdom
Bangor, Maine, United States
København ø, , Denmark
Lund, , Sweden
Peoria, Illinois, United States
Houston, Texas, United States
Oshawa, Ontario, Canada
Praha 2, , Czechia
Kingwood, Texas, United States
Changchun, , China
Dalian, , China
Shenyang, , China
Somerset, New Jersey, United States
Nishinomiya Shi, , Japan
Airdrie, , United Kingdom
Martin, , Slovakia
Saint Louis, Missouri, United States
Flint, Michigan, United States
Orchard Park, New York, United States
Odense C, , Denmark
Wilmington, Delaware, United States
Miami, Florida, United States
Wellington, Florida, United States
Cumming, Georgia, United States
Mar Del Plata, , Argentina
Ramos Mejía, , Argentina
San Nicolás, , Argentina
Santa Fe, , Argentina
Campina Grande Do Sul, , Brazil
Marilia, , Brazil
São José Do Rio Preto, , Brazil
Kyustendil, , Bulgaria
Brampton, Ontario, Canada
Terrebonne, Quebec, Canada
Quebec, , Canada
Changsha, , China
Nanchang, , China
Tianjin, , China
Ahmedabad, , India
Apeldoorn, , Netherlands
Sneek, , Netherlands
Katowice, , Poland
Lublin, , Poland
Sokółka, , Poland
Wierzchosławice, , Poland
Izhevsk, , Russian Federation
Perm, , Russian Federation
Tver, , Russian Federation
Nove Zamky, , Slovakia
Ostersund, , Sweden
Hanoi, , Vietnam
Tucker, Georgia, United States
Bridgewater, New Jersey, United States
Falls Church, Virginia, United States
Caba, , Argentina
Rosario, , Argentina
Greenfield Park, Quebec, Canada
Haerbin, , China
Ostrava Dubina, , Czechia
Dresden, , Germany
Hamburg, , Germany
Mosonmagyaróvár, , Hungary
Beppu Shi, , Japan
Itabashi Ku, , Japan
Kishiwada Shi, , Japan
Meguro Ku, , Japan
Miura Gun, , Japan
Sakaide Shi, , Japan
Suwa Shi, , Japan
Ekaterinburg, , Russian Federation
Gatchina, , Russian Federation
Novosibirsk, , Russian Federation
Trnava, , Slovakia
Göteborg, , Sweden
Stockholm, , Sweden
Den Bosch, , Netherlands
Hazel Crest, Illinois, United States
Jerseyville, Illinois, United States
Peterborough, Ontario, Canada
Veldhoven, , Netherlands
Nanjing, , China
Shenzhen, , China
Xuzhou, , China
Saint Augustine, Florida, United States
Bengbu, , China
Kasama Shi, , Japan
Homburg, , Germany
Kure Shi, , Japan
Leipzig, , Germany
Sayama Shi, , Japan
Shinjuku Ku, , Japan
Fairhope, Alabama, United States
Sheffield, Alabama, United States
New Smyrna Beach, Florida, United States
San Luis, , Argentina
Brasillia, , Brazil
Porto Alegre, , Brazil
Votuporanga, , Brazil
Lom, , Bulgaria
Waterloo, Ontario, Canada
Pingxiang, , China
Kolin, , Czechia
Louny, , Czechia
Praha 5, , Czechia
Trebic, , Czechia
Svendborg, , Denmark
Papenburg, , Germany
New Delhi, , India
Adachi Ku, , Japan
Chikushino Shi, , Japan
Chuo Ku, , Japan
Fujisawa Shi, , Japan
Hachioji Shi, , Japan
Iwakuni Shi, , Japan
Kumamoto Shi, , Japan
Okayama Shi, , Japan
Sanyoonoda Shi, , Japan
Takamatsu Shi, , Japan
Wako Shi, , Japan
Yokohama Shi, , Japan
Bochnia, , Poland
Jasło, , Poland
Kędzierzyn Koźle, , Poland
Ryazan, , Russian Federation
Brezno, , Slovakia
Svidnik, , Slovakia
Changhua City, , Taiwan
Hsinchu, , Taiwan
Paisley, , United Kingdom
Glasgow, , United Kingdom
Lanzhou, , China
Praha, , Czechia
Matsudo Shi, , Japan
Matsuyama Shi, , Japan
Osaka Shi, , Japan
Sendai Shi, , Japan
Tsuchiura Shi, , Japan
Bunkyo Ku, , Japan
Ueda Shi, , Japan
Bronx, New York, United States
Maharashtra, , India
Nagpur, , India
łódź, , Poland
Hitachinaka Shi, , Japan
Matsumoto Shi, , Japan
St. Petersburg, , Russian Federation
Rimouski, Quebec, Canada
Iizuka Shi, , Japan
Wuhan, , China
Stuttgart, , Germany
Kyoto Shi, , Japan
Nagoya Shi, , Japan
Kagoshima Shi, , Japan
Gurgaon, , India
Ningbo, , China
Yekaterinburg, , Russian Federation
Uberlandia, , Brazil
Toride Shi, , Japan
Farmington, Utah, United States
North Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Chalmette, Louisiana, United States
Baltimore, Maryland, United States
Cleveland, Ohio, United States
San Antonio, Texas, United States
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aire, , Argentina
Ciudad De Buenos Aires, , Argentina
Cordoba, , Argentina
Córdoba, , Argentina
Esperanza, , Argentina
Quilmes, , Argentina
San Martin, , Argentina
Vicente Lopez, , Argentina
Belo Horizonte, , Brazil
Campinas, , Brazil
Goiânia, , Brazil
Abbotsford, British Columbia, Canada
Moncton, New Brunswick, Canada
Newmarket, Ontario, Canada
North York, Ontario, Canada
Oakville, Ontario, Canada
Port Perry, Ontario, Canada
Scarborough, Ontario, Canada
York, Ontario, Canada
Baotou, , China
Chifeng, , China
Zhuhai, , China
Plzen, , Czechia
Aurangabad, , India
Bangalore, , India
Belagavi, , India
Ernakulam, , India
Kanpur, , India
Karamsad, , India
Kolkata, , India
Nadiad, , India
Aki Gun,, , Japan
Azumino Shi, , Japan
Fukuoka Shi, , Japan
Hamamatsu Shi, , Japan
Himeji Shi, , Japan
Hiratsuka Shi, , Japan
Kakamigahara Shi, , Japan
Kitakyusyu Shi, , Japan
Kusatsu Shi, , Japan
Mito Shi, , Japan
Nagasaki Shi, , Japan
Sagamihara Shi, , Japan
Sakai Shi,Kita Ku, , Japan
Shimonoseki Shi, , Japan
Suita Shi, , Japan
Tachikawa Shi, , Japan
Takasaki Shi, , Japan
Tsukuba Shi, , Japan
Wakayama Shi, , Japan
Den Haag, , Netherlands
Kraków, , Poland
Oława, , Poland
Saint Petersburg, , Russian Federation
Umeå, , Sweden
Clydebank, , United Kingdom
Ho Chi Minh, , Vietnam
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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