Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
NCT ID: NCT03036124
Last Updated: 2020-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4744 participants
INTERVENTIONAL
2017-02-08
2019-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dapagliflozin
Patients will be randomized 1:1 to either dapagliflozin or placebo.
Dapagliflozin
10 mg or 5 mg tablets given once daily, per oral use.
Placebo
Placebo matching dapagliflozin.
Placebo
Placebo matching dapagliflozin 10 mg or 5 mg.
Interventions
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Dapagliflozin
10 mg or 5 mg tablets given once daily, per oral use.
Placebo
Placebo matching dapagliflozin 10 mg or 5 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Fairhope, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Vista, California, United States
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Wilmington, Delaware, United States
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Boynton Beach, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lake Worth, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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New Smyrna Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Port Charlotte, Florida, United States
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Saint Augustine, Florida, United States
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Wellington, Florida, United States
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Atlanta, Georgia, United States
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Cumming, Georgia, United States
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Tucker, Georgia, United States
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Hazel Crest, Illinois, United States
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Jerseyville, Illinois, United States
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Peoria, Illinois, United States
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Louisville, Kentucky, United States
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Alexandria, Louisiana, United States
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Chalmette, Louisiana, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Boston, Massachusetts, United States
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Haverhill, Massachusetts, United States
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Flint, Michigan, United States
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Flint, Michigan, United States
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Lansing, Michigan, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Tupelo, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Grand Island, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Bridgewater, New Jersey, United States
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New Brunswick, New Jersey, United States
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Somerset, New Jersey, United States
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Buffalo, New York, United States
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Buffalo, New York, United States
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Cortlandt Manor, New York, United States
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New York, New York, United States
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Orchard Park, New York, United States
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Poughkeepsie, New York, United States
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Rosedale, New York, United States
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The Bronx, New York, United States
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Burlington, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Altoona, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Tullahoma, Tennessee, United States
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Beaumont, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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San Antonio, Texas, United States
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Tyler, Texas, United States
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Farmington, Utah, United States
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Falls Church, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Caba, , Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Esperanza, , Argentina
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Mar del Plata, , Argentina
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Mar del Plata, , Argentina
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Quilmes, , Argentina
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Ramos Mejía, , Argentina
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Rosario, , Argentina
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Santa Fe, , Argentina
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Vicente López, , Argentina
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Belo Horizonte, , Brazil
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Brasillia, , Brazil
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Brasília, , Brazil
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Campina Grande do Sul, , Brazil
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Campinas, , Brazil
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Curitiba, , Brazil
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Goiânia, , Brazil
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Marília, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
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Uberlândia, , Brazil
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Votuporanga, , Brazil
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Blagoevgrad, , Bulgaria
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Dimitrovgrad, , Bulgaria
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Haskovo, , Bulgaria
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Kyustendil, , Bulgaria
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Lom, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Abbotsford, British Columbia, Canada
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New Westminster, British Columbia, Canada
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North Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Cambridge, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Oshawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Port Perry, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Waterloo, Ontario, Canada
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York, Ontario, Canada
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Greenfield Park, 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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Rimouski, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Terrebonne, Quebec, Canada
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Baotou, , China
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changsha, , China
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Chifeng, , China
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Dalian, , China
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Guangzhou, , China
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Haerbin, , China
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Lanzhou, , China
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Nanchang, , China
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Nanjing, , China
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Nanjing, , China
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Ningbo, , China
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Pingxiang, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Tianjin, , China
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Wuhan, , China
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Wuhan, , China
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Xuzhou, , China
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Xuzhou, , China
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Yinchuan, , China
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Zhuhai, , China
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Benešov, , Czechia
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Brno, , Czechia
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Brno, , Czechia
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Kolín, , Czechia
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Louny, , Czechia
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Ostrava-Dubina, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Třebíč, , Czechia
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Hellerup, , Denmark
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Herlev, , Denmark
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Hvidovre, , Denmark
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København Ø, , Denmark
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Odense C, , Denmark
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Svendborg, , Denmark
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Bad Oeynhausen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Homburg, , Germany
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Kassel, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Papenburg, , Germany
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Stuttgart, , Germany
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Wermsdorf, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Kecskemét, , Hungary
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Mosonmagyaróvár, , Hungary
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Szentes, , Hungary
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Székesfehérvár, , Hungary
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Zalaegerszeg, , Hungary
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Ahmedabad, , India
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Aurangabad, , India
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Bangalore, , India
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Belagavi, , India
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Ernākulam, , India
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Gurgaon, , India
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Kanpur, , India
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Karamsad, , India
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Kolkata, , India
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Maharashtra, , India
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Nadiād, , India
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Nagpur, , India
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Nagpur, , India
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New Delhi, , India
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Pune, , India
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Pune, , India
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Adachi-ku, , Japan
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Aki-gun,, , Japan
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Azumino-shi, , Japan
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Beppu-shi, , Japan
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Bunkyō City, , Japan
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Chikushino-shi, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Fujisawa-shi, , Japan
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Fujisawa-shi, , Japan
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Fukuoka, , Japan
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Hachioji-shi, , Japan
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Hamamatsu, , Japan
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Himeji-shi, , Japan
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Hiratsuka-shi, , Japan
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Hitachi-Naka, , Japan
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Iizuka-shi, , Japan
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Itabashi-ku, , Japan
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Iwakuni-shi, , Japan
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Kagoshima, , Japan
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Kakamigahara-shi, , Japan
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Kasama-shi, , Japan
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Kishiwada-shi, , Japan
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Kitakyusyu-shi, , Japan
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Kumamoto, , Japan
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Kure-shi, , Japan
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Kusatsu-shi, , Japan
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Kyoto, , Japan
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Matsudo-shi, , Japan
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Matsudo-shi, , Japan
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Matsumoto-shi, , Japan
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Matsuyama, , Japan
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Meguro-ku, , Japan
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Mito, , Japan
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Miura-gun, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nishinomiya-shi, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sagamihara-shi, , Japan
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Sakai-shi,Kita-ku, , Japan
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Sakaide-shi, , Japan
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Sanyoonoda-shi, , Japan
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Sayama-shi, , Japan
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Sendai, , Japan
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Sendai, , Japan
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Shimonoseki-shi, , Japan
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Shinjuku-ku, , Japan
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Suwa-shi, , Japan
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Tachikawa-shi, , Japan
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Takamatsu, , Japan
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Takasaki-shi, , Japan
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Toride-shi, , Japan
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Tsukuba, , Japan
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Ueda-shi, , Japan
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Wakayama, , Japan
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Wakayama, , Japan
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Wako-shi, , Japan
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Yokohama, , Japan
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's-Hertogenbosch, , Netherlands
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Apeldoorn, , Netherlands
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Gouda, , Netherlands
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Groningen, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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Sneek, , Netherlands
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The Hague, , Netherlands
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Veldhoven, , Netherlands
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Bochnia, , Poland
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Gdynia, , Poland
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Jasło, , Poland
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Katowice, , Poland
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Kędzierzyn-Koźle, , Poland
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Krakow, , Poland
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Legnica, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Oława, , Poland
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Płock, , Poland
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Sokółka, , Poland
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Torun, , Poland
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Wierzchosławice, , Poland
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Gatchina, , Russia
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Izhevsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Perm, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Tver', , Russia
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Yekaterinburg, , Russia
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Brezno, , Slovakia
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Košice, , Slovakia
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Lučenec, , Slovakia
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Martin, , Slovakia
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Nové Zámky, , Slovakia
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Prešov, , Slovakia
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Svidník, , Slovakia
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Trebišov, , Slovakia
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Trnava, , Slovakia
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Žilina, , Slovakia
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Gothenburg, , Sweden
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Lund, , Sweden
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Östersund, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Changhua, , Taiwan
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Hsinchu, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Kweishan Shiang, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Airdrie, , United Kingdom
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Clydebank, , United Kingdom
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Cottingham, , United Kingdom
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Dundee, , 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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Inverness, , United Kingdom
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Nottingham, , United Kingdom
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Paisley, , United Kingdom
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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References
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Butt JH, Docherty KF, Kosiborod MN, Inzucchi SE, Kober L, Langkilde AM, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon S, Jhund PS, McMurray JJV. Dapagliflozin and Physical and Social Activity Limitations in Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2023 Oct;11(10):1411-1423. doi: 10.1016/j.jchf.2023.04.016. Epub 2023 Jun 14.
Butt JH, Kondo T, Yang M, Jhund PS, Docherty KF, Vaduganathan M, Claggett BL, Hernandez AF, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Kosiborod MN, Desai AS, Kober L, Ponikowski P, Sabatine MS, Shah SJ, Zaozerska N, Wilderang U, Bengtsson O, Solomon SD, McMurray JJV. Heart failure, peripheral artery disease, and dapagliflozin: a patient-level meta-analysis of DAPA-HF and DELIVER. Eur Heart J. 2023 Jun 25;44(24):2170-2183. doi: 10.1093/eurheartj/ehad276.
Bhatt AS, Kosiborod MN, Vaduganathan M, Claggett BL, Miao ZM, Kulac IJ, Lam CSP, Hernandez AF, Martinez F, Inzucchi SE, Shah SJ, de Boer RA, Jhund PS, Desai AS, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Effect of dapagliflozin on health status and quality of life across the spectrum of ejection fraction: Participant-level pooled analysis from the DAPA-HF and DELIVER trials. Eur J Heart Fail. 2023 Jul;25(7):981-988. doi: 10.1002/ejhf.2909. Epub 2023 Jun 7.
Chatur S, Kondo T, Claggett BL, Docherty K, Miao ZM, Desai AS, Jhund PS, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez FA, Shah SJ, Petersson M, Langkilde AM, McMurray JJV, Solomon SD, Vaduganathan M. Effects of dapagliflozin on heart failure hospitalizations according to severity of inpatient course: Insights from DELIVER and DAPA-HF. Eur J Heart Fail. 2023 Aug;25(8):1364-1371. doi: 10.1002/ejhf.2912. Epub 2023 Jun 8.
Yeoh SE, Docherty KF, Campbell RT, Jhund PS, Hammarstedt A, Heerspink HJL, Jarolim P, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Solomon SD, Sjostrand M, Bengtsson O, Greasley PJ, Sattar N, Welsh P, Sabatine MS, Morrow DA, McMurray JJV. Endothelin-1, Outcomes in Patients With Heart Failure and Reduced Ejection Fraction, and Effects of Dapagliflozin: Findings From DAPA-HF. Circulation. 2023 May 30;147(22):1670-1683. doi: 10.1161/CIRCULATIONAHA.122.063327. Epub 2023 Apr 11.
Butt JH, Docherty KF, Claggett BL, Desai AS, Fang JC, Petersson M, Langkilde AM, de Boer RA, Cabrera Honorio JW, Hernandez AF, Inzucchi SE, Kosiborod MN, Kober L, Lam CSP, Martinez FA, Ponikowski P, Sabatine MS, Vardeny O, O'Meara E, Saraiva JFK, Shah SJ, Vaduganathan M, Jhund PS, Solomon SD, McMurray JJV. Dapagliflozin in Black and White Patients With Heart Failure Across the Ejection Fraction Spectrum. JACC Heart Fail. 2023 Apr;11(4):375-388. doi: 10.1016/j.jchf.2022.11.014. Epub 2023 Feb 1.
Butt JH, Docherty KF, Claggett BL, Desai AS, Petersson M, Langkilde AM, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Kober L, Lam CSP, Martinez FA, Ponikowski P, Sabatine MS, Shah SJ, Vaduganathan M, Jhund PS, Solomon SD, McMurray JJV. Association of Dapagliflozin Use With Clinical Outcomes and the Introduction of Uric Acid-Lowering Therapy and Colchicine in Patients With Heart Failure With and Without Gout: A Patient-Level Pooled Meta-analysis of DAPA-HF and DELIVER. JAMA Cardiol. 2023 Apr 1;8(4):386-393. doi: 10.1001/jamacardio.2022.5608.
Adamson C, Welsh P, Docherty KF, de Boer RA, Diez M, Drozdz J, Dukat A, Inzucchi SE, Kober L, Kosiborod MN, Ljungman CEA, Martinez FA, Ponikowski P, Sabatine MS, Morrow DA, Lindholm D, Hammarstedt A, Boulton DW, Greasley PJ, Langkilde AM, Solomon SD, Sattar N, McMurray JJV, Jhund PS. IGFBP-7 and Outcomes in Heart Failure With Reduced Ejection Fraction: Findings From DAPA-HF. JACC Heart Fail. 2023 Mar;11(3):291-304. doi: 10.1016/j.jchf.2022.09.004. Epub 2022 Nov 9.
Docherty KF, Anand IS, Chiang CE, Chopra VK, Desai AS, Kitakaze M, Verma S, Vinh PN, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Langkilde AM, Jhund PS, McMurray JJV. Effects of Dapagliflozin in Asian Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF. JACC Asia. 2022 Mar 29;2(2):139-153. doi: 10.1016/j.jacasi.2022.02.004. eCollection 2022 Apr.
Desai AS, Jhund PS, Claggett BL, Vaduganathan M, Miao ZM, Kondo T, Barkoudah E, Brahimi A, Connolly E, Finn P, Lang NN, Mc Causland FR, McGrath M, Petrie MC, McMurray JJV, Solomon SD. Effect of Dapagliflozin on Cause-Specific Mortality in Patients With Heart Failure Across the Spectrum of Ejection Fraction: A Participant-Level Pooled Analysis of DAPA-HF and DELIVER. JAMA Cardiol. 2022 Dec 1;7(12):1227-1234. doi: 10.1001/jamacardio.2022.3736.
Adamson C, Cowan LM, de Boer RA, Diez M, Drozdz J, Dukat A, Inzucchi SE, Kober L, Kosiborod MN, Ljungman CEA, Martinez FA, Ponikowski P, Sabatine MS, Lindholm D, Bengtsson O, Boulton DW, Greasley PJ, Langkilde AM, Sjostrand M, Solomon SD, McMurray JJV, Jhund PS. Liver tests and outcomes in heart failure with reduced ejection fraction: findings from DAPA-HF. Eur J Heart Fail. 2022 Oct;24(10):1856-1868. doi: 10.1002/ejhf.2649. Epub 2022 Aug 22.
Docherty KF, Welsh P, Verma S, De Boer RA, O'Meara E, Bengtsson O, Kober L, Kosiborod MN, Hammarstedt A, Langkilde AM, Lindholm D, Little DJ, Sjostrand M, Martinez FA, Ponikowski P, Sabatine MS, Morrow DA, Schou M, Solomon SD, Sattar N, Jhund PS, McMurray JJV; DAPA-HF Investigators and Committees. Iron Deficiency in Heart Failure and Effect of Dapagliflozin: Findings From DAPA-HF. Circulation. 2022 Sep 27;146(13):980-994. doi: 10.1161/CIRCULATIONAHA.122.060511. Epub 2022 Aug 16.
Butt JH, Dewan P, DeFilippis EM, Biering-Sorensen T, Docherty KF, Jhund PS, Kosiborod MN, Martinez FA, Bengtsson O, Johansen ND, Langkilde AM, Sjostrand M, Vaduganathan M, Solomon SD, Sabatine MS, Kober L, Fiuzat M, McMurray JJV. Effects of Dapagliflozin According to the Heart Failure Collaboratory Medical Therapy Score: Insights From DAPA-HF. JACC Heart Fail. 2022 Aug;10(8):543-555. doi: 10.1016/j.jchf.2022.03.009. Epub 2022 Jun 8.
Yeoh SE, Docherty KF, Jhund PS, Petrie MC, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Boulton DW, Greasley PJ, Langkilde AM, Sjostrand M, Solomon SD, McMurray JJV. Relationship of Dapagliflozin With Serum Sodium: Findings From the DAPA-HF Trial. JACC Heart Fail. 2022 May;10(5):306-318. doi: 10.1016/j.jchf.2022.01.019. Epub 2022 Apr 6.
Butt JH, Dewan P, Merkely B, Belohlavek J, Drozdz J, Kitakaze M, Inzucchi SE, Kosiborod MN, Martinez FA, Tereshchenko S, Ponikowski P, Bengtsson O, Lindholm D, Langkilde AM, Schou M, Sjostrand M, Solomon SD, Sabatine MS, Chiang CE, Docherty KF, Jhund PS, Kober L, McMurray JJV. Efficacy and Safety of Dapagliflozin According to Frailty in Heart Failure With Reduced Ejection Fraction : A Post Hoc Analysis of the DAPA-HF Trial. Ann Intern Med. 2022 Jun;175(6):820-830. doi: 10.7326/M21-4776. Epub 2022 Apr 26.
Adamson C, Docherty KF, Heerspink HJL, de Boer RA, Damman K, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Petrie MC, Ponikowski P, Sabatine MS, Schou M, Solomon SD, Verma S, Bengtsson O, Langkilde AM, Sjostrand M, Vaduganathan M, Jhund PS, McMurray JJV. Initial Decline (Dip) in Estimated Glomerular Filtration Rate After Initiation of Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: Insights From DAPA-HF. Circulation. 2022 Aug 9;146(6):438-449. doi: 10.1161/CIRCULATIONAHA.121.058910. Epub 2022 Apr 20.
Docherty KF, Simpson J, Jhund PS, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Sjostrand M, Lindholm D, Langkilde AM, Solomon SD, McMurray JJV; DAPA-HF Investigators and Committees. Effect of Dapagliflozin, Compared With Placebo, According to Baseline Risk in DAPA-HF. JACC Heart Fail. 2022 Feb;10(2):104-118. doi: 10.1016/j.jchf.2021.09.002. Epub 2022 Jan 12.
Docherty KF, Ogunniyi MO, Anand IS, Desai AS, Diez M, Howlett JG, Nicolau JC, O'Meara E, Verma S, Inzucchi SE, Kober L, Kosiborod MN, Lindholm D, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Langkilde AM, Jhund PS, McMurray JJV. Efficacy of Dapagliflozin in Black Versus White Patients With Heart Failure and Reduced Ejection Fraction. JACC Heart Fail. 2022 Jan;10(1):52-64. doi: 10.1016/j.jchf.2021.08.006. Epub 2021 Nov 10.
Ryden L, Ferrannini G. Is the impact of add on heart failure therapy influenced by background therapy? Lancet Diabetes Endocrinol. 2022 Jan;10(1):3-5. doi: 10.1016/S2213-8587(21)00311-9. Epub 2021 Nov 30. No abstract available.
Butt JH, Adamson C, Docherty KF, de Boer RA, Petrie MC, Inzucchi SE, Kosiborod MN, Maria Langkilde A, Lindholm D, Martinez FA, Bengtsson O, Schou M, O'Meara E, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Jhund PS, McMurray JJV, Kober L. Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to N-Terminal Pro-B-Type Natriuretic Peptide: Insights From the DAPA-HF Trial. Circ Heart Fail. 2021 Dec;14(12):e008837. doi: 10.1161/CIRCHEARTFAILURE.121.008837. Epub 2021 Nov 22.
Berg DD, Docherty KF, Sattar N, Jarolim P, Welsh P, Jhund PS, Anand IS, Chopra V, de Boer RA, Kosiborod MN, Nicolau JC, O'Meara E, Schou M, Hammarstedt A, Langkilde AM, Lindholm D, Sjostrand M, McMurray JJV, Sabatine MS, Morrow DA. Serial Assessment of High-Sensitivity Cardiac Troponin and the Effect of Dapagliflozin in Patients With Heart Failure With Reduced Ejection Fraction: An Analysis of the DAPA-HF Trial. Circulation. 2022 Jan 18;145(3):158-169. doi: 10.1161/CIRCULATIONAHA.121.057852. Epub 2021 Nov 8.
Curtain JP, Docherty KF, Jhund PS, Petrie MC, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Langkilde AM, Sjostrand M, Solomon SD, McMurray JJV. Effect of dapagliflozin on ventricular arrhythmias, resuscitated cardiac arrest, or sudden death in DAPA-HF. Eur Heart J. 2021 Sep 21;42(36):3727-3738. doi: 10.1093/eurheartj/ehab560.
Docherty KF, Jhund PS, Claggett B, Ferreira JP, Bengtsson O, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, McMurray JJV; DAPA-HF Investigators and Committees. Extrapolating Long-term Event-Free and Overall Survival With Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis of a Phase 3 Randomized Clinical Trial. JAMA Cardiol. 2021 Nov 1;6(11):1298-1305. doi: 10.1001/jamacardio.2021.2632.
Adamson C, Jhund PS, Docherty KF, Belohlavek J, Chiang CE, Diez M, Drozdz J, Dukat A, Howlett J, Ljungman CEA, Petrie MC, Schou M, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Bengtsson O, Langkilde AM, Lindholm D, Sjostrand M, McMurray JJV. Efficacy of dapagliflozin in heart failure with reduced ejection fraction according to body mass index. Eur J Heart Fail. 2021 Oct;23(10):1662-1672. doi: 10.1002/ejhf.2308. Epub 2021 Jul 29.
Jhund PS, Ponikowski P, Docherty KF, Gasparyan SB, Bohm M, Chiang CE, Desai AS, Howlett J, Kitakaze M, Petrie MC, Verma S, Bengtsson O, Langkilde AM, Sjostrand M, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Sabatine MS, Solomon SD, McMurray JJV. Dapagliflozin and Recurrent Heart Failure Hospitalizations in Heart Failure With Reduced Ejection Fraction: An Analysis of DAPA-HF. Circulation. 2021 May 18;143(20):1962-1972. doi: 10.1161/CIRCULATIONAHA.121.053659. Epub 2021 Apr 9.
Butt JH, Docherty KF, Petrie MC, Schou M, Kosiborod MN, O'Meara E, Katova T, Ljungman CEA, Diez M, Ogunniyi MO, Langkilde AM, Sjostrand M, Lindholm D, Bengtsson O, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Jhund PS, McMurray JJV, Kober L. Efficacy and Safety of Dapagliflozin in Men and Women With Heart Failure With Reduced Ejection Fraction: A Prespecified Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial. JAMA Cardiol. 2021 Jun 1;6(6):678-689. doi: 10.1001/jamacardio.2021.0379.
Berg DD, Jhund PS, Docherty KF, Murphy SA, Verma S, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Bengtsson O, Ponikowski P, Sjostrand M, Solomon SD, McMurray JJV, Sabatine MS. Time to Clinical Benefit of Dapagliflozin and Significance of Prior Heart Failure Hospitalization in Patients With Heart Failure With Reduced Ejection Fraction. JAMA Cardiol. 2021 May 1;6(5):499-507. doi: 10.1001/jamacardio.2020.7585.
Shen L, Kristensen SL, Bengtsson O, Bohm M, de Boer RA, Docherty KF, Inzucchi SE, Katova T, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Martinez MFA, O'Meara E, Nicolau JC, Petrie MC, Ponikowski P, Sabatine MS, Schou M, Sjostrand M, Solomon SD, Jhund PS, McMurray JJV. Dapagliflozin in HFrEF Patients Treated With Mineralocorticoid Receptor Antagonists: An Analysis of DAPA-HF. JACC Heart Fail. 2021 Apr;9(4):254-264. doi: 10.1016/j.jchf.2020.11.009. Epub 2021 Feb 3.
Dewan P, Docherty KF, Bengtsson O, de Boer RA, Desai AS, Drozdz J, Hawkins NM, Inzucchi SE, Kitakaze M, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Martinez FA, Merkely B, Petrie MC, Ponikowski P, Sabatine MS, Schou M, Sjostrand M, Solomon SD, Verma S, Jhund PS, McMurray JJV. Effects of dapagliflozin in heart failure with reduced ejection fraction and chronic obstructive pulmonary disease: an analysis of DAPA-HF. Eur J Heart Fail. 2021 Apr;23(4):632-643. doi: 10.1002/ejhf.2083. Epub 2021 Jan 18.
Inzucchi SE, Docherty KF, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Verma S, Belohlavek J, Bohm M, Chiang CE, de Boer RA, Diez M, Dukat A, Ljungman CEA, Bengtsson O, Langkilde AM, Sjostrand M, Jhund PS, McMurray JJV; DAPA-HF Investigators and Committees. Dapagliflozin and the Incidence of Type 2 Diabetes in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis From DAPA-HF. Diabetes Care. 2021 Feb;44(2):586-594. doi: 10.2337/dc20-1675. Epub 2020 Dec 18.
Yeoh SE, Dewan P, Jhund PS, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Bengtsson O, Sjostrand M, Langkilde AM, McMurray JJV; DAPA-HF Investigators and Committees. Patient Characteristics, Clinical Outcomes, and Effect of Dapagliflozin in Relation to Duration of Heart Failure: Is It Ever Too Late to Start a New Therapy? Circ Heart Fail. 2020 Dec;13(12):e007879. doi: 10.1161/CIRCHEARTFAILURE.120.007879. Epub 2020 Nov 9.
Docherty KF, Jhund PS, Bengtsson O, DeMets DL, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Sabatine MS, Sjostrand M, Solomon SD, McMurray JJV; DAPA-HF Investigators and Committees. Effect of Dapagliflozin in DAPA-HF According to Background Glucose-Lowering Therapy. Diabetes Care. 2020 Nov;43(11):2878-2881. doi: 10.2337/dc20-1402. Epub 2020 Sep 2.
Jhund PS, Solomon SD, Docherty KF, Heerspink HJL, Anand IS, Bohm M, Chopra V, de Boer RA, Desai AS, Ge J, Kitakaze M, Merkley B, O'Meara E, Shou M, Tereshchenko S, Verma S, Vinh PN, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Langkilde AM, Sjostrand M, McMurray JJV. Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients With Heart Failure With Reduced Ejection Fraction: Results of DAPA-HF. Circulation. 2021 Jan 26;143(4):298-309. doi: 10.1161/CIRCULATIONAHA.120.050391. Epub 2020 Oct 12.
Docherty KF, Jhund PS, Anand I, Bengtsson O, Bohm M, de Boer RA, DeMets DL, Desai AS, Drozdz J, Howlett J, Inzucchi SE, Johanson P, Katova T, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Martinez FA, Merkely B, Nicolau JC, O'Meara E, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Tereshchenko S, Verma S, McMurray JJV. Effect of Dapagliflozin on Outpatient Worsening of Patients With Heart Failure and Reduced Ejection Fraction: A Prespecified Analysis of DAPA-HF. Circulation. 2020 Oct 27;142(17):1623-1632. doi: 10.1161/CIRCULATIONAHA.120.047480. Epub 2020 Sep 4.
Serenelli M, Bohm M, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, DeMets DL, Bengtsson O, Sjostrand M, Langkilde AM, Anand IS, Chiang CE, Chopra VK, de Boer RA, Diez M, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Verma S, Docherty KF, Jhund PS, McMurray JJV. Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF). Eur Heart J. 2020 Sep 21;41(36):3402-3418. doi: 10.1093/eurheartj/ehaa496.
Jackson AM, Dewan P, Anand IS, Belohlavek J, Bengtsson O, de Boer RA, Bohm M, Boulton DW, Chopra VK, DeMets DL, Docherty KF, Dukat A, Greasley PJ, Howlett JG, Inzucchi SE, Katova T, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Ljungman CEA, Martinez FA, O'Meara E, Sabatine MS, Sjostrand M, Solomon SD, Tereshchenko S, Verma S, Jhund PS, McMurray JJV. Dapagliflozin and Diuretic Use in Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF. Circulation. 2020 Sep 15;142(11):1040-1054. doi: 10.1161/CIRCULATIONAHA.120.047077. Epub 2020 Jul 16.
Solomon SD, Jhund PS, Claggett BL, Dewan P, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Inzucchi SE, Desai AS, Bengtsson O, Lindholm D, Sjostrand M, Langkilde AM, McMurray JJV. Effect of Dapagliflozin in Patients With HFrEF Treated With Sacubitril/Valsartan: The DAPA-HF Trial. JACC Heart Fail. 2020 Oct;8(10):811-818. doi: 10.1016/j.jchf.2020.04.008. Epub 2020 Jul 8.
Dewan P, Solomon SD, Jhund PS, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, DeMets DL, Sabatine MS, Bengtsson O, Sjostrand M, Langkilde AM, Anand IS, Belohlavek J, Chopra VK, Dukat A, Kitakaze M, Merkely B, O'Meara E, Schou M, Vinh PN, McMurray JJV; DAPA-HF Investigators and Committees. Efficacy and safety of sodium-glucose co-transporter 2 inhibition according to left ventricular ejection fraction in DAPA-HF. Eur J Heart Fail. 2020 Jul;22(7):1247-1258. doi: 10.1002/ejhf.1867. Epub 2020 Jun 15.
Petrie MC, Verma S, Docherty KF, Inzucchi SE, Anand I, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett J, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Vinh PN, Schou M, Tereshchenko S, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Johanson P, Greasley PJ, Boulton D, Bengtsson O, Jhund PS, McMurray JJV. Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes. JAMA. 2020 Apr 14;323(14):1353-1368. doi: 10.1001/jama.2020.1906.
Kosiborod MN, Jhund PS, Docherty KF, Diez M, Petrie MC, Verma S, Nicolau JC, Merkely B, Kitakaze M, DeMets DL, Inzucchi SE, Kober L, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Bengtsson O, Lindholm D, Niklasson A, Sjostrand M, Langkilde AM, McMurray JJV. Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction: Results From the DAPA-HF Trial. Circulation. 2020 Jan 14;141(2):90-99. doi: 10.1161/CIRCULATIONAHA.119.044138. Epub 2019 Nov 17.
Martinez FA, Serenelli M, Nicolau JC, Petrie MC, Chiang CE, Tereshchenko S, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Ponikowski P, Sabatine MS, DeMets DL, Dutkiewicz-Piasecka M, Bengtsson O, Sjostrand M, Langkilde AM, Jhund PS, McMurray JJV. Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to Age: Insights From DAPA-HF. Circulation. 2020 Jan 14;141(2):100-111. doi: 10.1161/CIRCULATIONAHA.119.044133. Epub 2019 Nov 17.
McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
McMurray JJV, DeMets DL, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD; DAPA-HF Committees and Investigators. The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics. Eur J Heart Fail. 2019 Nov;21(11):1402-1411. doi: 10.1002/ejhf.1548. Epub 2019 Jul 15.
Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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Other Identifiers
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2016-003897-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1699C00001
Identifier Type: -
Identifier Source: org_study_id
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