Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (DELIVER)

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Placebo

Detailed Description

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind study in patients with HFpEF, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death and heart failure events (hospitalisations for HF or urgent HF visits). Adult patients aged ≥40 years with HFpEF (LVEF >40% and evidence of structural heart disease) and New York Heart Association (NYHA) class II-IV who are eligible according to the inclusion/exclusion criteria will be randomised in a 1:1 ratio to receive either dapagliflozin 10 mg or placebo. Both out-patients and in-patients hospitalised for heart failure and off intravenous heart failure-therapy for 24 hours can be randomised. It is estimated that approximately 11000 patients at approximately 400-500 sites in 20-25 countries will need to be enrolled to reach the target of approximately 6100 randomised patients.

• Study Type: Interventional
• Enrollment (Actual): 6263
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Research Site
  • Caba, Argentina, 1426
    • Research Site
  • Caba, Argentina, C1119ACN
    • Research Site
  • Caba, Argentina, C1425AGC
    • Research Site
  • Caba, Argentina, C1120AAC
    • Research Site
  • Catamarca, Argentina, K4700
    • Research Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1407GTN
    • Research Site
  • Cordoba, Argentina, 5003
    • Research Site
  • Cordoba, Argentina, X5000AAW
    • Research Site
  • Cordoba, Argentina, X5003DCP
    • Research Site
  • Cordoba, Argentina, X5006CBI
    • Research Site
  • Corrientes, Argentina, W3400AMZ
    • Research Site
  • Córdoba, Argentina, X5004BAL
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Research Site
  • Ramos Mejía, Argentina, B1704ETD
    • Research Site
  • Rosario, Argentina, 2000
    • Research Site
  • San Miguel de Tucuman, Argentina, 4000
    • Research Site
  • San Nicolás, Argentina, B2900DMH
    • Research Site
  • Santa Fe, Argentina, S3000FWO
    • Research Site
• Belgium
  • Aalst, Belgium, 9300
    • Research Site
  • Brasschaat, Belgium, 2930
    • Research Site
  • Bruxelles, Belgium, 1200
    • Research Site
  • Huy, Belgium, 4500
    • Research Site
  • Kortrijk, Belgium, 8500
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
• Brazil
  • Belo Horizonte, Brazil, 30150-240
    • Research Site
  • Belo Horizonte, Brazil, 30210-090
    • Research Site
  • Blumenau, Brazil, 89020-430
    • Research Site
  • Campina Grande do Sul, Brazil, 83430000
    • Research Site
  • Campinas, Brazil, 13060-080
    • Research Site
  • Campinas, Brazil, 13010-001
    • Research Site
  • Curitiba, Brazil, 80230-130
    • Research Site
  • Porto Alegre, Brazil, 90020090
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Research Site
  • Rio de Janeiro, Brazil, 20241-180
    • Research Site
  • Santo Andre, Brazil, 09080-110
    • Research Site
  • Sao Paulo, Brazil, 01141-020
    • Research Site
  • Votuporanga, Brazil, 15500-003
    • Research Site
• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • Research Site
  • Haskovo, Bulgaria
    • Research Site
  • Kozloduy, Bulgaria, 3320
    • Research Site
  • Pazardzhik, Bulgaria, 4400
    • Research Site
  • Pleven, Bulgaria, 5800
    • Research Site
  • Plovdiv, Bulgaria, 4004
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1784
    • Research Site
  • Sofia, Bulgaria, 1309
    • Research Site
  • Sofia, Bulgaria, 1606
    • Research Site
  • Sofia, Bulgaria, 1463
    • Research Site
  • Sofia, Bulgaria, 1700
    • Research Site
  • Stara Zagora, Bulgaria, 6000
    • Research Site
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Research Site
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
      • Research Site
    • Brampton, Ontario, Canada, L6W 2X7
      • Research Site
    • Burlington, Ontario, Canada, L7M 4Y1
      • Research Site
    • Cambridge, Ontario, Canada, N1R 6V6
      • Research Site
    • Hamilton, Ontario, Canada, L8L 2X2
      • Research Site
    • Newmarket, Ontario, Canada, L3Y 2P6
      • Research Site
    • North York, Ontario, Canada, M6B 3H7
      • Research Site
    • Oshawa, Ontario, Canada, L1J 2K1
      • Research Site
    • Port Perry, Ontario, Canada, L9L 1L1
      • Research Site
    • Scarborough, Ontario, Canada, M1B 4Z8
      • Research Site
    • Toronto, Ontario, Canada, M5B 1W8
      • Research Site
    • Toronto, Ontario, Canada, M3N 1N1
      • Research Site
    • Toronto, Ontario, Canada, M6G 1M2
      • Research Site
    • Toronto, Ontario, Canada, M6N 1B5
      • Research Site
    • Waterloo, Ontario, Canada, N2T 0C1
      • Research Site
    • York, Ontario, Canada, M9N 1W4
      • Research Site
  • Quebec
    • Laval, Quebec, Canada, H7M 3L9
      • Research Site
    • Montreal, Quebec, Canada, H1T 1C8
      • Research Site
    • Saint-Jerome, Quebec, Canada, J7Z 5T3
      • Research Site
    • Terrebonne, Quebec, Canada, J6V 2H2
      • Research Site
    • Trois-Rivieres, Quebec, Canada, G8Z 3R9
      • Research Site
• China
  • Baotou, China, 014010
    • Research Site
  • Beijing, China, 100853
    • Research Site
  • Beijing, China, 100029
    • Research Site
  • Beijing, China, 100049
    • Research Site
  • Cangzhou, China, 061001
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changchun, China, 130033
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Chifeng, China, 024000
    • Research Site
  • Dalian, China, 116011
    • Research Site
  • Daqing, China, 163000
    • Research Site
  • Fuzhou, China, 350025
    • Research Site
  • Fuzhou, China, 350031
    • Research Site
  • Guangzhou, China, 510120
    • Research Site
  • Guangzhou, China, 510100
    • Research Site
  • Haerbin, China, 150001
    • Research Site
  • Jinan, China, 250013
    • Research Site
  • Lanzhou, China, 730030
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 2100008
    • Research Site
  • Nanjing, China, 210009
    • Research Site
  • Nanjing, China, 210011
    • Research Site
  • Pingxiang, China, 337055
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 200062
    • Research Site
  • Shanghai, China, 200090
    • Research Site
  • Shenyang, China, 110015
    • Research Site
  • Tianjin, China, 300457
    • Research Site
  • Tianjin, China, 300000
    • Research Site
  • Tianjin, China, 300142
    • Research Site
  • Tianjin, China, 300211
    • Research Site
  • Wuhan, China, 430000
    • Research Site
  • Wuhan, China, 430033
    • Research Site
  • Xi'an, China, 710061
    • Research Site
  • Yinchuan, China, 750004
    • Research Site
• Czechia
  • Benesov, Czechia, 256 01
    • Research Site
  • Brandys nad Labem, Czechia, 250 01
    • Research Site
  • Brno, Czechia, 612 00
    • Research Site
  • Jaromer, Czechia, 551 01
    • Research Site
  • Kladno, Czechia, 272 80
    • Research Site
  • Louny, Czechia, 440 01
    • Research Site
  • Nachod, Czechia, 547 01
    • Research Site
  • Ostrava-Dubina, Czechia, 700 30
    • Research Site
  • Pardubice, Czechia, 532 03
    • Research Site
  • Praha 2, Czechia, 12808
    • Research Site
  • Pribram, Czechia, 261 01
    • Research Site
• Hungary
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1171
    • Research Site
  • Budapest, Hungary, 1139
    • Research Site
  • Győr, Hungary, 9024
    • Research Site
  • Kecskemét, Hungary, 6000
    • Research Site
  • Miskolc, Hungary, 3529
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Szekszárd, Hungary, 7100
    • Research Site
  • Szentes, Hungary, 6600
    • Research Site
  • Szolnok, Hungary, 5000
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
  • Zalaegerszeg, Hungary, 8900
    • Research Site
• Japan
  • Adachi-ku, Japan, 123-0845
    • Research Site
  • Asahi-shi, Japan, 289-2511
    • Research Site
  • Azumino-shi, Japan, 399-8292
    • Research Site
  • Beppu-shi, Japan, 874-0011
    • Research Site
  • Chuo-ku, Japan, 103-0027
    • Research Site
  • Fujisawa-shi, Japan, 251-8550
    • Research Site
  • Fujisawa-shi, Japan, 251-0041
    • Research Site
  • Funabashi-shi, Japan, 274-0065
    • Research Site
  • Hachioji-shi, Japan, 192-0918
    • Research Site
  • Hamada-shi, Japan, 697-8511
    • Research Site
  • Hamamatsu-shi, Japan, 430-0929
    • Research Site
  • Higashiohmi-shi, Japan, 527-8505
    • Research Site
  • Ichinomiya-shi, Japan, 494-0001
    • Research Site
  • Iizuka-shi, Japan, 820-8505
    • Research Site
  • Iwakuni-shi, Japan, 740-8510
    • Research Site
  • Kanazawa-shi, Japan, 920-8650
    • Research Site
  • Kasugai-shi, Japan, 487-0016
    • Research Site
  • Kawasaki-shi, Japan, 210-0852
    • Research Site
  • Kishiwada-shi, Japan, 596-8522
    • Research Site
  • Kobe-shi, Japan, 654-0155
    • Research Site
  • Koga-shi, Japan, 306-0041
    • Research Site
  • Kuki-shi, Japan, 346-0021
    • Research Site
  • Kure-shi, Japan, 737-0023
    • Research Site
  • Kyoto-shi, Japan, 612-8555
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  • Matsumoto-shi, Japan, 390-8621
    • Research Site
  • Mito-shi, Japan, 311-4198
    • Research Site
  • Miura-gun, Japan, 240-0116
    • Research Site
  • Nakagami-gun, Japan, 901-2393
    • Research Site
  • Nishinomiya-shi, Japan, 663-8501
    • Research Site
  • Oita-shi, Japan, 870-0855
    • Research Site
  • Saga-shi, Japan, 840-8571
    • Research Site
  • Sagamihara-shi, Japan, 252-5188
    • Research Site
  • Sapporo-shi, Japan, 063-0005
    • Research Site
  • Shinagawa-ku, Japan, 140-8522
    • Research Site
  • Suita-shi, Japan, 564-8565
    • Research Site
  • Takamatsu-shi, Japan, 760-0018
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  • Takasago-shi, Japan, 676-0812
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  • Toride-shi, Japan, 302-0022
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  • Tsu-shi, Japan, 514-1101
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  • Tsuchiura-shi, Japan, 300-0028
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  • Ueda-shi, Japan, 386-8610
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  • Ureshino-shi, Japan, 843-0393
    • Research Site
  • Utsunomiya-shi, Japan, 320-8580
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20230
    • Research Site
  • Culiacán, Mexico, 80200
    • Research Site
  • Guadalajara, Mexico, 44210
    • Research Site
  • Mazatlán, Mexico, 82000
    • Research Site
  • Mexico, Mexico, 06700
    • Research Site
  • Monclova, Mexico, 25750
    • Research Site
  • Monterey, Mexico, 64060
    • Research Site
  • Monterrey, Mexico, 64020
    • Research Site
  • México, Mexico, 11650
    • Research Site
  • Querétaro, Mexico, 76000
    • Research Site
  • Tijuana, Mexico, 22150
    • Research Site
  • Veracruz, Mexico, 91900
    • Research Site
  • Veracruz, Mexico, 91910
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1061 AE
    • Research Site
  • Arnhem, Netherlands, 6815 AD
    • Research Site
  • Den Haag, Netherlands, 2545 AA
    • Research Site
  • Dordrecht, Netherlands, 3318 AT
    • Research Site
  • Groningen, Netherlands, 9700 RB
    • Research Site
  • Heerlen, Netherlands, 6419 PC
    • Research Site
  • Leiderdorp, Netherlands, 2353 GA
    • Research Site
  • Meppel, Netherlands, 7943 KA
    • Research Site
  • Rotterdam, Netherlands, 3083 AN
    • Research Site
  • Uden, Netherlands, 5406 PT
    • Research Site
  • Veldhoven, Netherlands, 5504 DB
    • Research Site
• Peru
  • Bellavista, Peru, CALLAO 2
    • Research Site
  • Callao, Peru, CALLAO 2
    • Research Site
  • Chancay, Peru, 15131
    • Research Site
  • Chorrillos, Peru, Lima 9
    • Research Site
  • Lima, Peru, LIMA 41
    • Research Site
  • Lima, Peru, 14
    • Research Site
  • Lima, Peru, LIMA 1
    • Research Site
  • Lima, Peru, LIMA 31
    • Research Site
  • Lima, Peru, 15088
    • Research Site
  • Lima, Peru, L11
    • Research Site
  • Lima, Peru, L18
    • Research Site
  • San Isidro, Peru, 15073
    • Research Site
  • Urb. El Chipe, Peru, 20007
    • Research Site
• Poland
  • Białystok, Poland, 15-111
    • Research Site
  • Bochnia, Poland, 32-700
    • Research Site
  • Chojnice, Poland, 89-600
    • Research Site
  • Gdańsk, Poland, 80-286
    • Research Site
  • Gdynia, Poland, 81-157
    • Research Site
  • Gdynia, Poland, 81-423
    • Research Site
  • Jasło, Poland, 38-200
    • Research Site
  • Katowice, Poland, 40-081
    • Research Site
  • Lublin, Poland, 20-044
    • Research Site
  • Opole, Poland, 45-056
    • Research Site
  • Oława, Poland, 55-200
    • Research Site
  • Płock, Poland, 09-402
    • Research Site
  • Rzeszów, Poland, 35-055
    • Research Site
  • Torun, Poland, 87-100
    • Research Site
  • Wierzchosławice, Poland, 33-122
    • Research Site
  • Wroclaw, Poland, 50-981
    • Research Site
  • Łódź, Poland, 92-213
    • Research Site
• Romania
  • Brasov, Romania, 500365
    • Research Site
  • Craiova, Romania, 200642
    • Research Site
  • Iasi, Romania, 700304
    • Research Site
  • Iasi, Romania, 700400
    • Research Site
  • Iasi, Romania, 700515
    • Research Site
  • Tg Mures, Romania, 540143
    • Research Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454091
    • Research Site
  • Moscow, Russian Federation, 119991
    • Research Site
  • Moscow, Russian Federation, 121552
    • Research Site
  • Moscow, Russian Federation, 109263
    • Research Site
  • Moscow, Russian Federation, 111539
    • Research Site
  • Moscow, Russian Federation, 117292
    • Research Site
  • Novosibirsk, Russian Federation, 630055
    • Research Site
  • Perm, Russian Federation, 614056
    • Research Site
  • Ryazan, Russian Federation, 390039
    • Research Site
  • Saint Petersburg, Russian Federation, 198260
    • Research Site
  • Saint-Petersburg, Russian Federation, 199226
    • Research Site
  • Saint-Petersburg, Russian Federation, 191015
    • Research Site
  • Saint-Petersburg, Russian Federation, 194354
    • Research Site
  • Tver, Russian Federation, 170036
    • Research Site
• Saudi Arabia
  • Dammam, Saudi Arabia, 31463
    • Research Site
  • Jeddah, Saudi Arabia, 22252
    • Research Site
  • Jeddah, Saudi Arabia, 21499
    • Research Site
  • Riyadh, Saudi Arabia, 11426
    • Research Site
  • Riyadh, Saudi Arabia, 11462
    • Research Site
  • Riyadh, Saudi Arabia, 11525
    • Research Site
• Spain
  • A Coruña, Spain, 15006
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Hospitalet de Llobregat(Barcel, Spain, 08907
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Sanlúcar De Barrameda (Cádiz), Spain, 11540
    • Research Site
  • Santiago(A Coruña), Spain, 15706
    • Research Site
  • Sevilla, Spain, 41071
    • Research Site
  • Valencia, Spain, 46010
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Villamartín (Cádiz), Spain, 11650
    • Research Site
• Taiwan
  • Hsinchu, Taiwan, 300
    • Research Site
  • Kaohsiung, Taiwan, 82445
    • Research Site
  • Kaohsiung, Taiwan, 80756
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan
    • Research Site
  • Taichung, Taiwan, 40201
    • Research Site
  • Tainan, Taiwan, 704
    • Research Site
  • Taipei, Taiwan
    • Research Site
  • Taipei, Taiwan, 11217
    • Research Site
  • Taipei, Taiwan, 114
    • Research Site
  • Taipei, Taiwan, 11220
    • Research Site
  • Taipei City, Taiwan, 110
    • Research Site
  • Taoyuan City, Taiwan, 333
    • 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
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Research Site
  • California
    • Beverly Hills, California, United States, 90211
      • Research Site
    • Loma Linda, California, United States, 92357
      • Research Site
    • Los Angeles, California, United States, 90073
      • Research Site
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Research Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • Research Site
    • Miami, Florida, United States, 33155
      • Research Site
    • Naples, Florida, United States, 34102
      • Research Site
    • Ocala, Florida, United States, 34471
      • Research Site
    • Ormond Beach, Florida, United States, 32174
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
    • Saint Augustine, Florida, United States, 32086
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Research Site
    • Chicago, Illinois, United States, 60637
      • Research Site
    • Gurnee, Illinois, United States, 60031
      • Research Site
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Research Site
    • Munster, Indiana, United States, 46321
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site
  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • Research Site
    • Houma, Louisiana, United States, 70360
      • Research Site
    • Monroe, Louisiana, United States, 71201
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Research Site
    • Boston, Massachusetts, United States, 02114
      • Research Site
  • Michigan
    • Bay City, Michigan, United States, 48708
      • Research Site
    • Flint, Michigan, United States, 48504
      • Research Site
    • Flint, Michigan, United States, 48532
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Research Site
    • Rochester, Minnesota, United States, 55905
      • Research Site
    • Saint Paul, Minnesota, United States, 55102
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Research Site
    • Kansas City, Missouri, United States, 64128
      • Research Site
    • Saint Louis, Missouri, United States, 63136
      • Research Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Research Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Research Site
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Research Site
  • New York
    • Buffalo, New York, United States, 14215
      • Research Site
    • New York, New York, United States, 10021
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • New York, New York, United States, 10001
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Research Site
    • Greensboro, North Carolina, United States, 27405
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Research Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16601
      • Research Site
    • Doylestown, Pennsylvania, United States, 18901
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Research Site
    • Nashville, Tennessee, United States, 37212
      • Research Site
    • Tullahoma, Tennessee, United States, 37388
      • Research Site
  • Texas
    • Beaumont, Texas, United States, 77701
      • Research Site
    • Humble, Texas, United States, 77338
      • Research Site
    • Sherman, Texas, United States, 75092
      • Research Site
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Research Site
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Research Site
    • Leesburg, Virginia, United States, 20176
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  • West Virginia
    • Morgantown, West Virginia, United States, 26506
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  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Research Site
    • Milwaukee, Wisconsin, United States, 53295
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Research Site
  • Ho Chi Minh, Vietnam
    • Research Site
  • Ho Chi Minh, Vietnam, 700000
    • Research Site
  • Ho Chi Minh, Vietnam, 70000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 128 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed informed consent prior to any study specific procedures.
2. Male or female patients age ≥40 years.
3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
4. Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
5. Elevated NT-pro BNP levels.
6. Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.

Further details regarding inclusion criteria 4-6 may apply.

Exclusion Criteria:

1. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
2. Type 1 diabetes mellitus (T1D).
3. eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
4. Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
9. Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
10. Body mass index >50 kg/m2.

Further exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• 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 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

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.	Dual primary efficacy Primary endpoint analysed in all patients randomised (Full analysis set). The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.	Up to 42.1 months
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation	Dual primary efficacy Primary endpoint analysed in all patients randomised with LVEF < 60% at baseline. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.	Up to 42.1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit)	Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.	Up to 42.1 months
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation	Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients with LVEF < 60% at baseline The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.	Up to 42.1 months
Change From Baseline in the KCCQ Total Symptom Score at 8 Months	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 Endpoint of Cardiovascular Death	Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.	Up to 42.1 months
Subjects Included in the Endpoint of All-cause Mortality	Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.	Up to 42.1 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAEs), amputations, adverse events (AEs) leading to amputation and potential risk factor AEs for amputations affecting lower limbs	Safety: To evaluate the safety and tolerability of dapagliflozin compared to placebo in patients with HFpEF	up to approximately 39 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.
• Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.
• Inzucchi SE, Claggett BL, Vaduganathan M, Desai AS, Jhund PS, de Boer RA, Hernandez AF, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Verma S, Han Y, Kerr Saraiva JF, Bengtsson O, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Efficacy and safety of dapagliflozin in patients with heart failure with mildly reduced or preserved ejection fraction by baseline glycaemic status (DELIVER): a subgroup analysis from an international, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2022 Dec;10(12):869-881. doi: 10.1016/S2213-8587(22)00308-4. Epub 2022 Nov 10.
• Vaduganathan M, Claggett BL, Jhund P, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Hegde SM, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Time to Clinical Benefit of Dapagliflozin in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Secondary Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2022 Dec 1;7(12):1259-1263. doi: 10.1001/jamacardio.2022.3750.
• 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.
• Myhre PL, Vaduganathan M, Claggett BL, Miao ZM, Jhund PS, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Influence of NT-proBNP on Efficacy of Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JACC Heart Fail. 2022 Dec;10(12):902-913. doi: 10.1016/j.jchf.2022.08.007. Epub 2022 Aug 27.
• Peters AE, Ogunniyi MO, Hegde SM, Bianco C, Ghafghazi S, Hernandez AF, DeVore AD. A multicenter program for electronic health record screening for patients with heart failure with preserved ejection fraction: Lessons from the DELIVER-EHR initiative. Contemp Clin Trials. 2022 Oct;121:106924. doi: 10.1016/j.cct.2022.106924. Epub 2022 Sep 12.
• Cunningham JW, Vaduganathan M, Claggett BL, Kulac IJ, Desai AS, Jhund PS, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, McGrath MM, O'Meara E, Wilderang U, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Dapagliflozin in Patients Recently Hospitalized With Heart Failure and Mildly Reduced or Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Oct 4;80(14):1302-1310. doi: 10.1016/j.jacc.2022.07.021. Epub 2022 Aug 27.
• Vaduganathan M, Claggett BL, Jhund P, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Estimated Long-Term Benefit of Dapagliflozin in Patients With Heart Failure. J Am Coll Cardiol. 2022 Nov 8;80(19):1775-1784. doi: 10.1016/j.jacc.2022.08.745. Epub 2022 Aug 27.
• Butt JH, Kondo T, Jhund PS, Comin-Colet J, de Boer RA, Desai AS, Hernandez AF, Inzucchi SE, Janssens SP, Kosiborod MN, Lam CSP, Langkilde AM, Lindholm D, Martinez F, Petersson M, Shah SJ, Thierer J, Vaduganathan M, Verma S, Wilderang U, Claggett BC, Solomon SD, McMurray JJV. Atrial Fibrillation and Dapagliflozin Efficacy in Patients With Preserved or Mildly Reduced Ejection Fraction. J Am Coll Cardiol. 2022 Nov 1;80(18):1705-1717. doi: 10.1016/j.jacc.2022.08.718. Epub 2022 Aug 27.
• Peikert A, Martinez FA, Vaduganathan M, Claggett BL, Kulac IJ, Desai AS, Jhund PS, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Shah SJ, Katova T, Merkely B, Vardeny O, Wilderang U, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Efficacy and Safety of Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction According to Age: The DELIVER Trial. Circ Heart Fail. 2022 Oct;15(10):e010080. doi: 10.1161/CIRCHEARTFAILURE.122.010080. Epub 2022 Aug 27.
• Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.
• Solomon SD, Vaduganathan M, Claggett BL, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Belohlavek J, Chiang CE, Willem Borleffs CJ, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Kerr Saraiva JF, Tereschenko SN, Thierer J, Vardeny O, Verma S, Vinh PN, Wilderang U, Zaozerska N, Lindholm D, Petersson M, McMurray JJV. Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction: DELIVER Trial. JACC Heart Fail. 2022 Mar;10(3):184-197. doi: 10.1016/j.jchf.2021.11.006.
• Mc Causland FR, Claggett BL, Vaduganathan M, Desai AS, Jhund P, de Boer RA, Docherty K, Fang J, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Saraiva JFK, McGrath MM, Shah SJ, Verma S, Langkilde AM, Petersson M, McMurray JJV, Solomon SD. Dapagliflozin and Kidney Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):56-65. doi: 10.1001/jamacardio.2022.4210.
• Butt JH, Jhund PS, Belohlavek J, de Boer RA, Chiang CE, Desai AS, Drozdz J, Hernandez AF, Inzucchi SE, Katova T, Kitakaze M, Kosiborod MN, Lam CSP, Maria Langkilde A, Lindholm D, Bachus E, Martinez F, Merkely B, Petersson M, Saraiva JFK, Shah SJ, Vaduganathan M, Vardeny O, Wilderang U, Claggett BL, Solomon SD, McMurray JJV. Efficacy and Safety of Dapagliflozin According to Frailty in Patients With Heart Failure: A Prespecified Analysis of the DELIVER Trial. Circulation. 2022 Oct 18;146(16):1210-1224. doi: 10.1161/CIRCULATIONAHA.122.061754. Epub 2022 Aug 27.

Helpful Links

• Redacted Clinical Study Protocol
• Redacted Statistical Analysis Plan
• Redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): March 27, 2022
• Study Completion (Actual): March 27, 2022

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• 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: D169CC00001; 2018-000802-46 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No