Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure (DAPA-HF)

Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 4744
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1180AAX
    • Research Site
  • Buenos Aires, Argentina, C1425AGC
    • Research Site
  • Caba, Argentina, C1119ACN
    • Research Site
  • Caba, Argentina, C1120AAC
    • Research Site
  • Caba, Argentina, 1428
    • Research Site
  • Caba, Argentina, 1437
    • Research Site
  • Caba, Argentina, C1425DQI
    • Research Site
  • Ciudad Autonoma Buenos Aires, Argentina, 1093
    • Research Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1407GTN
    • Research Site
  • Ciudad de Buenos Aires, Argentina, 1221
    • Research Site
  • Cordoba, Argentina, 5003
    • Research Site
  • Cordoba, Argentina, X5006CBI
    • Research Site
  • Corrientes, Argentina, W3400AMZ
    • Research Site
  • Córdoba, Argentina, X5004BAL
    • Research Site
  • Esperanza, Argentina, S3080BQU
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Research Site
  • Mar del Plata, Argentina, B7600FZN
    • Research Site
  • Quilmes, Argentina, B1878DVB
    • Research Site
  • Quilmes, Argentina, B1878GEG
    • Research Site
  • Ramos Mejía, Argentina, B1704ETD
    • Research Site
  • Rosario, Argentina, 2000
    • Research Site
  • Rosario, Argentina, S2000CVD
    • Research Site
  • San Luis, Argentina, 5700
    • Research Site
  • San Martin, Argentina, 1650
    • Research Site
  • San Miguel de Tucuman, Argentina, 4000
    • Research Site
  • San Nicolás, Argentina, B2900DMH
    • Research Site
  • Santa Fe, Argentina, S3000FWO
    • Research Site
  • Vicente Lopez, Argentina, 1638
    • Research Site
• Brazil
  • Belo Horizonte, Brazil, 30140 062
    • Research Site
  • Belo Horizonte, Brazil, 30150-240
    • Research Site
  • Brasilia, Brazil, 71625-175
    • Research Site
  • Brasillia, Brazil, 70200-730
    • Research Site
  • Campina Grande do Sul, Brazil, 83430000
    • Research Site
  • Campinas, Brazil, 13060-080
    • Research Site
  • Curitiba, Brazil, 80730-150
    • Research Site
  • Goiânia, Brazil, 74605050
    • Research Site
  • Marilia, Brazil, 17515-000
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Research Site
  • Porto Alegre, Brazil, 90020-090
    • Research Site
  • Porto Alegre, Brazil, 90620-001
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Research Site
  • Porto Alegre, Brazil, 90840-440
    • Research Site
  • Rio de Janeiro, Brazil, 22271-100
    • Research Site
  • Sao Paulo, Brazil, 05403-000
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • Uberlandia, Brazil, 38411-186
    • Research Site
  • Votuporanga, Brazil, 15500-003
    • Research Site
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Research Site
  • Dimitrovgrad, Bulgaria, 6400
    • Research Site
  • Haskovo, Bulgaria
    • Research Site
  • Kyustendil, Bulgaria, 2500
    • Research Site
  • Lom, Bulgaria, 3600
    • Research Site
  • Pleven, Bulgaria, 5800
    • Research Site
  • Plovdiv, Bulgaria, 4003
    • Research Site
  • Plovdiv, Bulgaria, 4000
    • Research Site
  • Plovdiv, Bulgaria, 4002
    • Research Site
  • Plovdiv, Bulgaria, 4001
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1527
    • Research Site
  • Sofia, Bulgaria, 1750
    • Research Site
  • Sofia, Bulgaria, 1309
    • Research Site
  • Sofia, Bulgaria, 1606
    • Research Site
  • Sofia, Bulgaria, 1463
    • Research Site
  • Sofia, Bulgaria, 1408
    • Research Site
• Canada
  • Quebec, Canada, G1V 4G5
    • Research Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Research Site
  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 3N2
      • Research Site
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Research Site
    • North Vancouver, British Columbia, Canada, V7M 2H4
      • Research Site
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Research Site
    • Saint John, New Brunswick, Canada, E2L 4L2
      • Research Site
  • Ontario
    • Brampton, Ontario, Canada, L6W 2X7
      • Research Site
    • Cambridge, Ontario, Canada, N1R 6V6
      • Research Site
    • Cambridge, Ontario, Canada, N1R 7R1
      • Research Site
    • Hamilton, Ontario, Canada, L8L 2X2
      • Research Site
    • London, Ontario, Canada, N6A 5A5
      • Research Site
    • Newmarket, Ontario, Canada, L3Y 2P6
      • Research Site
    • North York, Ontario, Canada, M6B 3H7
      • Research Site
    • Oakville, Ontario, Canada, L6K 3W7
      • Research Site
    • Oshawa, Ontario, Canada, L1J 2K1
      • Research Site
    • Peterborough, Ontario, Canada, K9J 0B2
      • Research Site
    • Port Perry, Ontario, Canada, L9L 1L1
      • Research Site
    • Scarborough, Ontario, Canada, M1E 5E9
      • Research Site
    • Scarborough, Ontario, Canada, M1B 4Z8
      • Research Site
    • Waterloo, Ontario, Canada, N2T 0C1
      • Research Site
    • York, Ontario, Canada, M9N 1W4
      • Research Site
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2G8
      • Research Site
    • Montreal, Quebec, Canada, H1T 1C8
      • Research Site
    • Montreal, Quebec, Canada, H2X 0A9
      • Research Site
    • Montreal, Quebec, Canada, H1T 3Y7
      • Research Site
    • Rimouski, Quebec, Canada, G5L 5T1
      • Research Site
    • Saint-Jerome, Quebec, Canada, J7Z 5T3
      • Research Site
    • Terrebonne, Quebec, Canada, J6V 2H2
      • Research Site
• China
  • Baotou, China, 014010
    • Research Site
  • Beijing, China
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Bengbu, China, 233060
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changsha, China, 410011
    • Research Site
  • Chifeng, China, 024000
    • Research Site
  • Dalian, China, 116011
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Haerbin, China, 150001
    • Research Site
  • Lanzhou, China, 730030
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210009
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Ningbo, China, 315010
    • Research Site
  • Pingxiang, China, 337055
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 200062
    • Research Site
  • Shanghai, China, 200090
    • Research Site
  • Shanghai, China, 200120
    • Research Site
  • Shenyang, China, 110001
    • Research Site
  • Shenzhen, China, 518036
    • Research Site
  • Tianjin, China, 300211
    • Research Site
  • Wuhan, China, 430060
    • Research Site
  • Wuhan, China, 430033
    • Research Site
  • Xuzhou, China, 221006
    • Research Site
  • Xuzhou, China, 221009
    • Research Site
  • Yinchuan, China, 750004
    • Research Site
  • Zhuhai, China, 519000
    • Research Site
• Czechia
  • Benesov, Czechia, 256 01
    • Research Site
  • Brno, Czechia, 656 91
    • Research Site
  • Brno, Czechia, 62500
    • Research Site
  • Kolin, Czechia, 280 00
    • Research Site
  • Louny, Czechia, 440 01
    • Research Site
  • Ostrava-Dubina, Czechia, 700 30
    • Research Site
  • Plzen, Czechia, 320 00
    • Research Site
  • Praha, Czechia, 140 59
    • Research Site
  • Praha 2, Czechia, 12808
    • Research Site
  • Praha 4, Czechia, 140 00
    • Research Site
  • Praha 5, Czechia, 150 00
    • Research Site
  • Trebic, Czechia, 674 01
    • Research Site
• Denmark
  • Hellerup, Denmark, 2900
    • Research Site
  • Herlev, Denmark, 2730
    • Research Site
  • Hvidovre, Denmark, 2650
    • Research Site
  • København Ø, Denmark, 2100
    • Research Site
  • Odense C, Denmark, 5000
    • Research Site
  • Svendborg, Denmark, DK-5700
    • Research Site
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Research Site
  • Berlin, Germany, 13597
    • Research Site
  • Berlin, Germany, 13347
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Dresden, Germany, 01099
    • Research Site
  • Hamburg, Germany, 22041
    • Research Site
  • Homburg, Germany, 66424
    • Research Site
  • Kassel, Germany, 34121
    • Research Site
  • Leipzig, Germany, 04107
    • Research Site
  • Mainz, Germany, 55131
    • Research Site
  • Papenburg, Germany, 26871
    • Research Site
  • Stuttgart, Germany, 70199
    • Research Site
  • Wermsdorf, Germany, 04779
    • Research Site
• Hungary
  • Budapest, Hungary, 1115
    • Research Site
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1135
    • Research Site
  • Budapest, Hungary, 1139
    • Research Site
  • Budapest, Hungary, H-1106
    • Research Site
  • Kecskemét, Hungary, 6000
    • Research Site
  • Mosonmagyaróvár, Hungary, 9200
    • Research Site
  • Szentes, Hungary, 6600
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
  • Zalaegerszeg, Hungary, 8900
    • Research Site
• India
  • Ahmedabad, India, 380060
    • Research Site
  • Aurangabad, India, 431003
    • Research Site
  • Bangalore, India, 560074
    • Research Site
  • Belagavi, India, 590010
    • Research Site
  • Ernakulam, India, 683594
    • Research Site
  • Gurgaon, India, 122001
    • Research Site
  • Kanpur, India, 208002
    • Research Site
  • Karamsad, India, 388345
    • Research Site
  • Kolkata, India, 700020
    • Research Site
  • Maharashtra, India, 411013
    • Research Site
  • Nadiad, India, 387002
    • Research Site
  • Nagpur, India, 420012
    • Research Site
  • Nagpur, India, 440003
    • Research Site
  • New Delhi, India, 110002
    • Research Site
  • Pune, India, 411001
    • Research Site
  • Pune, India, 411011
    • Research Site
• Japan
  • Adachi-ku, Japan, 123-0845
    • Research Site
  • Aki-gun,, Japan, 735-8585
    • Research Site
  • Azumino-shi, Japan, 399-8292
    • Research Site
  • Beppu-shi, Japan, 874-0011
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  • Bunkyo-ku, Japan, 113-8431
    • Research Site
  • Chikushino-shi, Japan, 818-8516
    • Research Site
  • Chuo-ku, Japan, 103-0027
    • Research Site
  • Chuo-ku, Japan, 104-8560
    • Research Site
  • Fujisawa-shi, Japan, 251-8550
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  • Fujisawa-shi, Japan, 251-0041
    • Research Site
  • Fukuoka-shi, Japan, 815-8555
    • Research Site
  • Hachioji-shi, Japan, 192-0918
    • Research Site
  • Hamamatsu-shi, Japan, 430-0929
    • Research Site
  • Himeji-shi, Japan, 670-0981
    • Research Site
  • Hiratsuka-shi, Japan, 254-8502
    • Research Site
  • Hitachinaka-shi, Japan, 312-0057
    • Research Site
  • Iizuka-shi, Japan, 820-8505
    • Research Site
  • Itabashi-ku, Japan, 173-8610
    • Research Site
  • Iwakuni-shi, Japan, 740-8510
    • Research Site
  • Kagoshima-shi, Japan, 890-8520
    • Research Site
  • Kakamigahara-shi, Japan, 504-8601
    • Research Site
  • Kasama-shi, Japan, 309-1793
    • Research Site
  • Kishiwada-shi, Japan, 596-8522
    • Research Site
  • Kitakyusyu-shi, Japan, 806-8501
    • Research Site
  • Kumamoto-shi, Japan, 860-0008
    • Research Site
  • Kure-shi, Japan, 737-0023
    • Research Site
  • Kusatsu-shi, Japan, 525-8585
    • Research Site
  • Kyoto-shi, Japan, 601-1434
    • Research Site
  • Matsudo-shi, Japan, 270-2251
    • Research Site
  • Matsudo-shi, Japan, 271-0077
    • Research Site
  • Matsumoto-shi, Japan, 390-8621
    • Research Site
  • Matsuyama-shi, Japan, 790-0067
    • Research Site
  • Meguro-ku, Japan, 152-8902
    • Research Site
  • Mito-shi, Japan, 311-4198
    • Research Site
  • Miura-gun, Japan, 240-0116
    • Research Site
  • Nagasaki-shi, Japan, 850-8555
    • Research Site
  • Nagoya-shi, Japan, 453-8511
    • Research Site
  • Nagoya-shi, Japan, 460-0001
    • Research Site
  • Nagoya-shi, Japan, 457-8511
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  • Nagoya-shi, Japan, 455-8530
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  • Nishinomiya-shi, Japan, 663-8501
    • Research Site
  • Okayama-shi, Japan, 700-0804
    • Research Site
  • Osaka-shi, Japan, 530-0001
    • Research Site
  • Osaka-shi, Japan, 540-0006
    • Research Site
  • Sagamihara-shi, Japan, 252-5188
    • Research Site
  • Sakai-shi,Kita-ku, Japan, 591-8025
    • Research Site
  • Sakaide-shi, Japan, 762-0007
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  • Sanyoonoda-shi, Japan, 756-0095
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  • Sayama-shi, Japan, 350-1305
    • Research Site
  • Sendai-shi, Japan, 980-0803
    • Research Site
  • Sendai-shi, Japan, 983-0045
    • Research Site
  • Shimonoseki-shi, Japan, 750-0061
    • Research Site
  • Shinjuku-ku, Japan, 169-0073
    • Research Site
  • Suita-shi, Japan, 564-8565
    • Research Site
  • Suwa-shi, Japan, 392-8510
    • Research Site
  • Tachikawa-shi, Japan, 190-8531
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  • Takamatsu-shi, Japan, 760-0018
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  • Takasaki-shi, Japan, 370-0829
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  • Toride-shi, Japan, 302-0022
    • Research Site
  • Tsuchiura-shi, Japan, 300-0028
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  • Tsukuba-shi, Japan, 305-0005
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  • Ueda-shi, Japan, 386-8610
    • Research Site
  • Wakayama-shi, Japan, 640-8505
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  • Wakayama-shi, Japan, 649-6335
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  • Wako-shi, Japan, 351-0102
    • Research Site
  • Yokohama-shi, Japan, 236-0051
    • Research Site
• Netherlands
  • Apeldoorn, Netherlands, 7334 DZ
    • Research Site
  • Den Bosch, Netherlands, 5223 GZ
    • Research Site
  • Den Haag, Netherlands, 2545 AA
    • Research Site
  • Gouda, Netherlands, 2803 HH
    • Research Site
  • Groningen, Netherlands, 9713 GZ
    • Research Site
  • Nijmegen, Netherlands, 6525 GA
    • Research Site
  • Rotterdam, Netherlands, 3045 PM
    • Research Site
  • Rotterdam, Netherlands, 3083 AN
    • Research Site
  • Sneek, Netherlands, 8601 ZR
    • Research Site
  • Veldhoven, Netherlands, 5504 DB
    • Research Site
• Poland
  • Bochnia, Poland, 32-700
    • Research Site
  • Gdynia, Poland, 81-423
    • Research Site
  • Jasło, Poland, 38-200
    • Research Site
  • Katowice, Poland, 40-081
    • Research Site
  • Kraków, Poland, 30-082
    • Research Site
  • Kędzierzyn Koźle, Poland, 47-200
    • Research Site
  • Legnica, Poland, 59-220
    • Research Site
  • Lublin, Poland, 20-044
    • Research Site
  • Oława, Poland, 55-200
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  • Płock, Poland, 09-402
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  • Sokółka, Poland, 16-100
    • Research Site
  • Torun, Poland, 87-100
    • Research Site
  • Wierzchosławice, Poland, 33-122
    • Research Site
  • Łódź, Poland, 92-213
    • Research Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620039
    • Research Site
  • Gatchina, Russian Federation, 188300
    • Research Site
  • Izhevsk, Russian Federation, 426063
    • Research Site
  • Kazan, Russian Federation, 420012
    • Research Site
  • Moscow, Russian Federation, 121552
    • Research Site
  • Moscow, Russian Federation, 109263
    • Research Site
  • Moscow, Russian Federation, 119435
    • Research Site
  • Moscow, Russian Federation, 121551
    • Research Site
  • Novosibirsk, Russian Federation, 630055
    • Research Site
  • Perm, Russian Federation, 6144090
    • Research Site
  • Ryazan, Russian Federation, 390039
    • Research Site
  • Saint Petersburg, Russian Federation, 196601
    • Research Site
  • Saint Petersburg, Russian Federation, 198260
    • Research Site
  • Saint-Petersburg, Russian Federation, 194291
    • Research Site
  • Saint-Petersburg, Russian Federation, 195067
    • Research Site
  • Saint-Petersburg, Russian Federation, 192283
    • Research Site
  • Saint-Petersburg, Russian Federation, 194354
    • Research Site
  • St. Petersburg, Russian Federation, 196084
    • Research Site
  • Tver, Russian Federation, 170036
    • Research Site
  • Yekaterinburg, Russian Federation, 620102
    • Research Site
• Slovakia
  • Brezno, Slovakia, 97742
    • Research Site
  • Kosice, Slovakia, 040 01
    • Research Site
  • Lucenec, Slovakia, 984 01
    • Research Site
  • Martin, Slovakia, 036 01
    • Research Site
  • Nove Zamky, Slovakia, 94001
    • Research Site
  • Presov, Slovakia, 080 01
    • Research Site
  • Svidnik, Slovakia, 08901
    • Research Site
  • Trebisov, Slovakia, 075 01
    • Research Site
  • Trnava, Slovakia, 917 01
    • Research Site
  • Zilina, Slovakia, 010 01
    • Research Site
• Sweden
  • Göteborg, Sweden, 413 45
    • Research Site
  • Lund, Sweden, 222 21
    • Research Site
  • Ostersund, Sweden, 831 83
    • Research Site
  • Stockholm, Sweden, 118 83
    • Research Site
  • Umeå, Sweden, 90737
    • Research Site
• Taiwan
  • Changhua City, Taiwan, 50006
    • Research Site
  • Hsinchu, Taiwan, 300
    • Research Site
  • Kaohsiung, Taiwan
    • Research Site
  • Kaohsiung, Taiwan, 80756
    • Research Site
  • Kweishan Shiang, Taiwan, 333
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan
    • Research Site
  • Tainan, Taiwan, 70403
    • Research Site
  • Tainan, Taiwan, 710
    • Research Site
  • Taipei, Taiwan
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taipei, Taiwan, 11220
    • Research Site
• United Kingdom
  • Airdrie, United Kingdom, ML6 0JS
    • Research Site
  • Clydebank, United Kingdom, G81 4DY
    • Research Site
  • Cottingham, United Kingdom, HU16 5JQ
    • Research Site
  • Dundee, United Kingdom, DD1 9SY
    • Research Site
  • Edinburgh, United Kingdom, EH16 4SA
    • Research Site
  • Glasgow, United Kingdom, G51 4TF
    • Research Site
  • Glasgow, United Kingdom, G31 2ER
    • Research Site
  • Inverness, United Kingdom, IV2 3JH
    • Research Site
  • Nottingham, United Kingdom, NG5 1PB
    • Research Site
  • Paisley, United Kingdom, PA2 9PN
    • Research Site
• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Research Site
    • Mobile, Alabama, United States, 36608
      • Research Site
    • Sheffield, Alabama, United States, 35660
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Los Angeles, California, United States, 90073
      • Research Site
    • Palm Springs, California, United States, 92262
      • Research Site
    • Stockton, California, United States, 95204
      • Research Site
    • Torrance, California, United States, 90502
      • Research Site
    • Vista, California, United States, 92083
      • Research Site
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Research Site
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Research Site
    • Jacksonville, Florida, United States, 32209
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Lake Worth, Florida, United States, 33461
      • Research Site
    • Miami, Florida, United States, 33125
      • Research Site
    • Miami, Florida, United States, 33155
      • Research Site
    • Naples, Florida, United States, 34102
      • Research Site
    • New Smyrna Beach, Florida, United States, 32169
      • Research Site
    • Pembroke Pines, Florida, United States, 33024
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
    • Saint Augustine, Florida, United States, 32086
      • Research Site
    • Wellington, Florida, United States, 33449
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Research Site
    • Cumming, Georgia, United States, 30041
      • Research Site
    • Tucker, Georgia, United States, 30084
      • Research Site
  • Illinois
    • Hazel Crest, Illinois, United States, 60429
      • Research Site
    • Jerseyville, Illinois, United States, 62052
      • Research Site
    • Peoria, Illinois, United States, 61614
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Research Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Research Site
    • Chalmette, Louisiana, United States, 70043
      • Research Site
  • Maine
    • Bangor, Maine, United States, 04401
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21228
      • Research Site
    • Baltimore, Maryland, United States, 21120
      • Research Site
    • Columbia, Maryland, United States, 21044
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Research Site
    • Haverhill, Massachusetts, United States, 01830
      • Research Site
  • Michigan
    • Flint, Michigan, United States, 48504
      • Research Site
    • Flint, Michigan, United States, 48532
      • Research Site
    • Lansing, Michigan, United States, 48910
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Research Site
    • Minneapolis, Minnesota, United States, 55417
      • Research Site
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
    • Saint Louis, Missouri, United States, 63128
      • Research Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • Research Site
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Research Site
    • Lincoln, Nebraska, United States, 68526
      • Research Site
    • Omaha, Nebraska, United States, 68105
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Research Site
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Research Site
    • New Brunswick, New Jersey, United States, 08901
      • Research Site
    • Somerset, New Jersey, United States, 08873
      • Research Site
  • New York
    • Bronx, New York, United States, 10459
      • Research Site
    • Buffalo, New York, United States, 14215
      • Research Site
    • Buffalo, New York, United States, 14203
      • Research Site
    • Cortlandt Manor, New York, United States, 10567
      • Research Site
    • New York, New York, United States, 10001
      • Research Site
    • Orchard Park, New York, United States, 14127
      • Research Site
    • Poughkeepsie, New York, United States, 12601
      • Research Site
    • Rosedale, New York, United States, 11422
      • Research Site
  • North Carolina
    • Burlington, North Carolina, United States, 27215
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44106-6010
      • Research Site
    • Columbus, Ohio, United States, 43210
      • Research Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15212
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15240
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37912
      • Research Site
    • Memphis, Tennessee, United States, 38104
      • Research Site
    • Nashville, Tennessee, United States, 37212
      • Research Site
    • Tullahoma, Tennessee, United States, 37388
      • Research Site
  • Texas
    • Beaumont, Texas, United States, 77702
      • Research Site
    • Dallas, Texas, United States, 75246
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • Houston, Texas, United States, 77002
      • Research Site
    • Kingwood, Texas, United States, 77339
      • Research Site
    • San Antonio, Texas, United States, 78234
      • Research Site
    • Tyler, Texas, United States, 75701
      • Research Site
  • Utah
    • Farmington, Utah, United States, 84025
      • Research Site
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Research Site
    • Richmond, Virginia, United States, 23298
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98101
      • Research Site
    • Seattle, Washington, United States, 98195
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Hanoi, Vietnam
    • Research Site
  • Hcmc, Vietnam
    • Research Site
  • Ho Chi Minh, Vietnam, 700000
    • Research Site
  • Ho Chi Minh, Vietnam, 70000
    • Research Site
  • Ho Chi Minh, Vietnam, 7000000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dapagliflozin; Patients will be randomized 1:1 to either dapagliflozin or placebo.	Drug: Dapagliflozin; 10 mg or 5 mg tablets given once daily, per oral use.; Other Names: Forxiga TM; Farxiga TM
PLACEBO_COMPARATOR: Placebo; Placebo matching dapagliflozin.	Drug: Placebo; Placebo matching dapagliflozin 10 mg or 5 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.	Primary efficacy	Up to 27.8 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	Secondary	Up to 27.8 months.
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.	Secondary	Up to 27.8 months.
Change From Baseline in the KCCQ Total Symptom Score	KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ total symptom score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	Baseline and 8 months or death before 8 months
Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.	Secondary	Up to 27.8 months.
Subjects Included in the Endpoint of All-cause Mortality.	Secondary	Up to 27.8 months.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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. Erratum In: Circulation. 2020 Nov 17;142(20):e369.
• 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. Erratum In: JAMA. 2021 Apr 6;325(13):1335.
• 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.

Helpful Links

• redacted protocol
• redacted Statistical Analysis Plan

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2017
• Primary Completion (ACTUAL): July 17, 2019
• Study Completion (ACTUAL): July 17, 2019

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: HFrEF; Heart Failure (HF); Cardiovascular Events (CV); Phase III outcome trial
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: D1699C00001; 2016-003897-41 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No