Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)Phase 3DAPA-HFNCT03036124

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

A Phase 3 study testing Dapagliflozin in people with Chronic Heart Failure With Reduced Ejection Fraction (HFrEF), run by AstraZeneca at 419 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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 Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,744 participants
Where: 419 sitesin 20 countries
Study dates: 8 Feb 2017to 17 Jul 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

419 sites in 20 countries.

Country

City, postcode or hospital

419 sites in 20 countries

United States86 sites

Research Site
Alexandria, Louisiana, 71301
Research Site
Altoona, Pennsylvania, 16602
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Atlanta, Georgia, 30303
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Bakersfield, California, 93309
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Baltimore, Maryland, 21120
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Baltimore, Maryland, 21228
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Bangor, Maine, 04401
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Beaumont, Texas, 77702
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Beverly Hills, California, 90211
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Boston, Massachusetts, 02114
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Boynton Beach, Florida, 33472
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Bridgewater, New Jersey, 08807
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Buffalo, New York, 14203
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Buffalo, New York, 14215
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Burlington, North Carolina, 27215
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Chalmette, Louisiana, 70043
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Cleveland, Ohio, 44106-6010
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Columbia, Maryland, 21044
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Columbus, Ohio, 43210
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Cortlandt Manor, New York, 10567
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Cumming, Georgia, 30041
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Dallas, Texas, 75231
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Dallas, Texas, 75246
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Fairhope, Alabama, 36532
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Falls Church, Virginia, 22042
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Farmington, Utah, 84025
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Flint, Michigan, 48504
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Flint, Michigan, 48532
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Grand Island, Nebraska, 68803
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Great Falls, Montana, 59405
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Haverhill, Massachusetts, 01830
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Hazel Crest, Illinois, 60429
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Houston, Texas, 77002
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Jacksonville, Florida, 32209
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Jacksonville, Florida, 32216
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Jerseyville, Illinois, 62052
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Kansas City, Missouri, 64111
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Kingwood, Texas, 77339
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Knoxville, Tennessee, 37912
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Lake Worth, Florida, 33461
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Lansing, Michigan, 48910
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Las Vegas, Nevada, 89128
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Lincoln, Nebraska, 68526
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Los Angeles, California, 90073
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Louisville, Kentucky, 40205
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Memphis, Tennessee, 38104
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Miami, Florida, 33125
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Miami, Florida, 33155
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Minneapolis, Minnesota, 55407
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Minneapolis, Minnesota, 55417
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Mobile, Alabama, 36608
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Naples, Florida, 34102
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Nashville, Tennessee, 37212
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New Brunswick, New Jersey, 08901
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New Smyrna Beach, Florida, 32169
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New York, New York, 10001
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Omaha, Nebraska, 68105
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Orchard Park, New York, 14127
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Palm Springs, California, 92262
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Pembroke Pines, Florida, 33024
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Peoria, Illinois, 61614
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Philadelphia, Pennsylvania, 19104
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Pittsburgh, Pennsylvania, 15212
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Pittsburgh, Pennsylvania, 15240
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Port Charlotte, Florida, 33952
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Poughkeepsie, New York, 12601
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Rapid City, South Dakota, 57701
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Richmond, Virginia, 23298
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Rosedale, New York, 11422
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Saint Augustine, Florida, 32086
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San Antonio, Texas, 78234
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Seattle, Washington, 98101
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Seattle, Washington, 98195
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Sheffield, Alabama, 35660
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Somerset, New Jersey, 08873
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St Louis, Missouri, 63128
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Stockton, California, 95204
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The Bronx, New York, 10459
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Torrance, California, 90502
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Tucker, Georgia, 30084
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Tullahoma, Tennessee, 37388
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Tupelo, Mississippi, 38801
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Tyler, Texas, 75701
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Vista, California, 92083
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Wellington, Florida, 33449
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Wilmington, Delaware, 19803

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Japan66 sites

Research Site
Adachi-ku, 123-0845
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Aki-gun,, 735-8585
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Azumino-shi, 399-8292
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Beppu-shi, 874-0011
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Bunkyō City, 113-8431
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Chikushino-shi, 818-8516
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Chūōku, 103-0027
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Chūōku, 104-8560
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Fujisawa-shi, 251-0041
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Fujisawa-shi, 251-8550
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Fukuoka, 815-8555
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Hachioji-shi, 192-0918
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Hamamatsu, 430-0929
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Himeji-shi, 670-0981
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Hiratsuka-shi, 254-8502
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Hitachi-Naka, 312-0057
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Iizuka-shi, 820-8505
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Iwakuni-shi, 740-8510
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Kagoshima, 890-8520
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Kakamigahara-shi, 504-8601
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Kasama-shi, 309-1793
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Kishiwada-shi, 596-8522
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Kitakyusyu-shi, 806-8501
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Kumamoto, 860-0008
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Kure-shi, 737-0023
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Kusatsu-shi, 525-8585
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Kyoto, 601-1434
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Matsudo-shi, 270-2251
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Matsudo-shi, 271-0077
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Matsumoto-shi, 390-8621
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Matsuyama, 790-0067
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Meguro-ku, 152-8902
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Mito, 311-4198
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Miura-gun, 240-0116
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Nagasaki, 850-8555
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Nagoya, 453-8511
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Nagoya, 455-8530
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Nagoya, 457-8511
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Nagoya, 460-0001
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Nishinomiya-shi, 663-8501
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Okayama, 700-0804
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Osaka, 530-0001
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Osaka, 540-0006
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Sagamihara-shi, 252-5188
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Sakai-shi,Kita-ku, 591-8025
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Sakaide-shi, 762-0007
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Sanyoonoda-shi, 756-0095
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Sayama-shi, 350-1305
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Sendai, 980-0803
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Sendai, 983-0045
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Shimonoseki-shi, 750-0061
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Shinjuku-ku, 169-0073
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Suita-shi, 564-8565
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Suwa-shi, 392-8510
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tabashi City, 173-8610
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Tachikawa-shi, 190-8531
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Takamatsu, 760-0018
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Takasaki-shi, 370-0829
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Toride-shi, 302-0022
Research Site
Tsuchiura-shi, 300-0028
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Tsukuba, 305-0005
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Ueda-shi, 386-8610
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Wakayama, 640-8505
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Wakayama, 649-6335
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Wako-shi, 351-0102
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Yokohama, 236-0051

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China30 sites

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Baotou, 014010
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Beijing, 100029
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Beijing
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Bengbu, 233060
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Changchun, 130021
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Changsha, 410011
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Chifeng, 024000
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Dalian, 116011
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Guangzhou, 510080
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Haerbin, 150001
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Lanzhou, 730030
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Nanchang, 330006
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Nanjing, 210009
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Nanjing, 210029
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Ningbo, 315010
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Pingxiang, 337055
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Shanghai, 200025
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Shanghai, 200032
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Shanghai, 200062
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Shanghai, 200090
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Shanghai, 200120
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Shenyang, 110001
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Shenzhen, 518036
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Tianjin, 300211
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Wuhan, 430033
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Wuhan, 430060
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Xuzhou, 221006
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Xuzhou, 221009
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Yinchuan, 750004
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Zhuhai, 519000

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Canada29 sites

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Abbotsford British Columbia, British Columbia, V2S 3N2
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Brampton, Ontario, L6W 2X7
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Calgary, Alberta, T2N 4Z6
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Cambridge, Ontario, N1R 6V6
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Cambridge, Ontario, N1R 7R1
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Greenfield Park, Quebec, J4V 2G8
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Hamilton, Ontario, L8L 2X2
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London, Ontario, N6A 5A5
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Moncton, New Brunswick, E1C 2Z3
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Montreal, Quebec, H1T 1C8
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Montreal, Quebec, H1T 3Y7
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Montreal, Quebec, H2X 0A9
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New Westminster, British Columbia, V3L 3W4
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Newmarket, Ontario, L3Y 2P6
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North Vancouver, British Columbia, V7M 2H4
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North York, Ontario, M6B 3H7
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Oakville, Ontario, L6K 3W7
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Oshawa, Ontario, L1J 2K1
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Peterborough, Ontario, K9J 0B2
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Port Perry, Ontario, L9L 1L1
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Québec, Quebec, G1V 4G5
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Rimouski, Quebec, G5L 5T1
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Saint John, New Brunswick, E2L 4L2
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Saint-Jérôme, Quebec, J7Z 5T3
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Scarborough Village, Ontario, M1B 4Z8
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Scarborough Village, Ontario, M1E 5E9
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Terrebonne, Quebec, J6V 2H2
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Waterloo, Ontario, N2T 0C1
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York, Ontario, M9N 1W4

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Argentina28 sites

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Buenos Aires, C1180AAX
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Buenos Aires, C1425AGC
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Caba, C1425DQI
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CABA, 1428
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CABA, 1437
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CABA, C1119ACN
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CABA, C1120AAC
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Ciudad Autonoma Buenos Aires, 1093
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Ciudad Autonoma de Buenos Aire, C1407GTN
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Ciudad de Buenos Aires, 1221
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Córdoba, 5003
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Córdoba, X5004BAL
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Córdoba, X5006CBI
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Corrientes, W3400AMZ
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Esperanza, S3080BQU
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Mar del Plata, 7600
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Mar del Plata, B7600FZN
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Quilmes, B1878DVB
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Quilmes, B1878GEG
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Ramos Mejía, B1704ETD
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Rosario, 2000
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Rosario, S2000CVD
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San Luis, 5700
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San Martin, 1650
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San Miguel de Tucumán, 4000
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San Nicolás, B2900DMH
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Santa Fe, S3000FWO
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Vicente López, 1638

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Russia20 sites

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Gatchina, 188300
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Izhevsk, 426063
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Kazan', 420012
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Moscow, 109263
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Moscow, 119435
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Moscow, 121551
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Moscow, 121552
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Novosibirsk, 630055
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Perm, 6144090
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Ryazan, 390039
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Saint Petersburg, 192283
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Saint Petersburg, 194291
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Saint Petersburg, 194354
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Saint Petersburg, 195067
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Saint Petersburg, 196084
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Saint Petersburg, 196601
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Saint Petersburg, 198260
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Tver', 170036
Research Site
Yekaterinburg, 620039
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Yekaterinburg, 620102

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Brazil19 sites

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Belo Horizonte, 30140 062
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Belo Horizonte, 30150-240
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Brasília, 71625-175
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Brasillia, 70200-730
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Campina Grande do Sul, 83430000
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Campinas, 13060-080
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Curitiba, 80730-150
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Goiânia, 74605050
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Marília, 17515-000
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Porto Alegre, 90020-090
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Porto Alegre, 90035-903
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Porto Alegre, 90620-001
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Porto Alegre, 90840-440
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Porto Alegre, 91350-200
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Rio de Janeiro, 22271-100
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São José do Rio Preto, 15090-000
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São Paulo, 05403-000
Research Site
Uberlândia, 38411-186
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Votuporanga, 15500-003

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Bulgaria17 sites

Research Site
Blagoevgrad, 2700
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Dimitrovgrad, 6400
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Haskovo
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Kyustendil, 2500
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Lom, 3600
Research Site
Pleven, 5800
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Plovdiv, 4000
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Plovdiv, 4001
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Plovdiv, 4002
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Plovdiv, 4003
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Sofia, 1309
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Sofia, 1408
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Sofia, 1431
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Sofia, 1463
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Sofia, 1527
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Sofia, 1606
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Sofia, 1750

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India16 sites

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Ahmedabad, 380060
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Bangalore, 560074
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Belagavi, 590010
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Chhatrapati Sambhajinagar, 431003
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Ernākulam, 683594
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Gūrgaon, 122001
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Kanpur, 208002
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Karamsad, 388345
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Kolkata, 700020
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Maharashtra, 411013
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Nadiād, 387002
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Nagpur, 420012
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Nagpur, 440003
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New Delhi, 110002
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Pune, 411001
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Pune, 411011

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Poland14 sites

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Bochnia, 32-700
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Gdynia, 81-423
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Jasło, 38-200
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Katowice, 40-081
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Kędzierzyn-Koźle, 47-200
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Krakow, 30-082
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Legnica, 59-220
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Lodz, 92-213
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Lublin, 20-044
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Oława, 55-200
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Płock, 09-402
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Sokółka, 16-100
Research Site
Torun, 87-100
Research Site
Wierzchosławice, 33-122

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Germany13 sites

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Bad Oeynhausen, 32545
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Berlin, 13347
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Berlin, 13597
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Dresden, 01099
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Dresden, 01307
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Hamburg, 22041
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Homburg, 66424
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Kassel, 34121
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Leipzig, 04107
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Mainz, 55131
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Papenburg, 26871
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Stuttgart, 70199
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Wermsdorf, 04779

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Czechia12 sites

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Benešov, 256 01
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Brno, 62500
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Brno, 656 91
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Kolín, 280 00
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Louny, 440 01
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Ostrava-Dubina, 700 30
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Pilsen, 320 00
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Prague, 12808
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Prague, 140 00
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Prague, 140 59
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Prague, 150 00
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Třebíč, 674 01

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Taiwan12 sites

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Changhua, 50006
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Hsinchu, 300
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Kaohsiung City, 80756
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Kaohsiung City
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Kweishan Shiang, 333
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Taichung, 40705
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Taichung
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Tainan, 70403
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Tainan, 710
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Taipei, 11217
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Taipei, 11220
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Taipei

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Hungary10 sites

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Budapest, 1115
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Budapest, 1122
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Budapest, 1135
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Budapest, 1139
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Budapest, H-1106
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Kecskemét, 6000
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Mosonmagyaróvár, 9200
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Székesfehérvár, 8000
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Szentes, 6600
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Zalaegerszeg, 8900

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Netherlands10 sites

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's-Hertogenbosch, 5223 GZ
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Apeldoorn, 7334 DZ
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Gouda, 2803 HH
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Groningen, 9713 GZ
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Nijmegen, 6525 GA
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Rotterdam, 3045 PM
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Rotterdam, 3083 AN
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Sneek, 8601 ZR
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The Hague, 2545 AA
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Veldhoven, 5504 DB

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Slovakia10 sites

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Brezno, 97742
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Košice, 040 01
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Lučenec, 984 01
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Martin, 036 01
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Nové Zámky, 94001
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Prešov, 080 01
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Svidník, 08901
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Trebišov, 075 01
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Trnava, 917 01
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Žilina, 010 01

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United Kingdom10 sites

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Airdrie, ML6 0JS
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Clydebank, G81 4DY
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Cottingham, HU16 5JQ
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Dundee, DD1 9SY
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Edinburgh, EH16 4SA
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Glasgow, G31 2ER
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Glasgow, G51 4TF
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Inverness, IV2 3JH
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Nottingham, NG5 1PB
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Denmark6 sites

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Hellerup, 2900
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Herlev, 2730
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Hvidovre, 2650
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København Ø, 2100
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Odense C, 5000
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Svendborg, DK-5700

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Vietnam6 sites

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Hanoi, 100000
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Hanoi
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Ho Chi Minh City, 7000000
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Ho Chi Minh City, 700000
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Ho Chi Minh City, 70000
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Sweden5 sites

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Lund, 222 21
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Östersund, 831 83
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Stockholm, 118 83
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About this study

Official title: 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

Read the 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.

Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Being tested: Dapagliflozin, Placebo
Keywords: HFrEF, Heart Failure (HF), Cardiovascular Events (CV), Phase III outcome trial
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
Also called Forxiga TM, Farxiga TM
10 mg or 5 mg tablets given once daily, per oral use.
PlaceboDrug
Placebo matching dapagliflozin 10 mg or 5 mg.

Study groups in NCT03036124
Study group	Role	What they receive
Dapagliflozin	Experimental	Patients will be randomized 1:1 to either dapagliflozin or placebo. Receives: Drug: Dapagliflozin
Placebo	Placebo comparator	Placebo matching dapagliflozin. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
Primary efficacy
Measured: Up to 27.8 months.

Secondary outcomes (5)

Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Secondary
Measured: Up to 27.8 months.
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
Secondary
Measured: 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.
Measured: 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
Measured: Up to 27.8 months.
Subjects Included in the Endpoint of All-cause Mortality.
Secondary
Measured: Up to 27.8 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 201717 Jul 2019

First posted30 Jan 2017 (estimated)
Study start8 Feb 2017
Primary completion17 Jul 2019
Study completion17 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (52)Papers the sponsor has linked to this study.
Other trials for Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,744 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03036124
Sponsor's protocol ID: D1699C00001
Other IDs: 2016-003897-41, 2016
Acronym: DAPA-HF
Status last verified: Aug 2020
First submitted: 26 Jan 2017
Last updated: 1 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Myte R, Mattsson A, Poole M, Little DJ, Nystrom P, Henderson A, Claggett BL, Gasparyan SB, Solomon SD, McMurray JJV. Survival Odds to Minimize Risk Heterogeneity Bias in Heart Failure Trials: Application to Dapagliflozin. Circ Heart Fail. 2025 Dec;18(12):e013496. doi: 10.1161/CIRCHEARTFAILURE.125.013496. Epub 2025 Oct 31.
PubMed 41170566
McDowell K, Welsh P, Docherty KF, Morrow DA, Jhund PS, De Boer RA, O'Meara E, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Hammarstedt A, Langkilde AM, Solomon SD, Sattar N, Sabatine MS, McMurray JJV. Cellular Adhesion Molecules and Adverse Outcomes in Chronic Heart Failure: Findings From the DAPA-HF Randomized Clinical Trial. JAMA Cardiol. 2025 Aug 1;10(8):797-808. doi: 10.1001/jamacardio.2025.1592.
PubMed 40465275
Docherty KF, McDowell K, Welsh P, Petrie MC, Anand I, Berg DD, de Boer RA, Kober L, Kosiborod MN, Martinez FA, O'Meara E, Morrow DA, Ponikowski P, Sabatine MS, Sattar N, Schou M, Hammarstedt A, Sjostrand M, Langkilde AM, Jhund PS, Solomon SD, McMurray JJV. Interleukin-6 in Heart Failure With Reduced Ejection Fraction and the Effect of Dapagliflozin: An Exploratory Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial. JACC Heart Fail. 2025 Jul;13(7):102393. doi: 10.1016/j.jchf.2024.12.012. Epub 2025 Mar 12.
PubMed 40088234
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
Kondo T, Mogensen UM, Talebi A, Gasparyan SB, Campbell RT, Docherty KF, de Boer RA, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Sabatine MS, Bengtsson O, Sjostrand M, Vaduganathan M, Solomon SD, Jhund PS, McMurray JJV. Dapagliflozin and Days of Full Health Lost in the DAPA-HF Trial. J Am Coll Cardiol. 2024 May 21;83(20):1973-1986. doi: 10.1016/j.jacc.2024.03.385. Epub 2024 Mar 25.
PubMed 38537918
Kondo T, Gasparyan SB, Jhund PS, Bengtsson O, Claggett BL, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Kober L, Lam CSP, Langkilde AM, Martinez FA, Petersson M, Ponikowski P, Sabatine MS, Shah SJ, Sjostrand M, Wilderang U, Vaduganathan M, Solomon SD, McMurray JJV. Use of Win Statistics to Analyze Outcomes in the DAPA-HF and DELIVER Trials. NEJM Evid. 2023 Nov;2(11):EVIDoa2300042. doi: 10.1056/EVIDoa2300042. Epub 2023 Oct 24.
PubMed 38320525
Kondo T, Butt JH, Curtain JP, Jhund PS, Docherty KF, Claggett BL, Vaduganathan M, Bachus E, Hernandez AF, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Kosiborod MN, Desai AS, Kober L, Ponikowski P, Sabatine MS, Solomon SD, McMurray JJV. Efficacy of Dapagliflozin According to Heart Rate: A Patient-Level Pooled Analysis of DAPA-HF and DELIVER. Circ Heart Fail. 2023 Dec;16(12):e010898. doi: 10.1161/CIRCHEARTFAILURE.123.010898. Epub 2023 Oct 27.
PubMed 37886880
Docherty KF, McDowell K, Welsh P, Osmanska J, Anand I, de Boer RA, Kober L, Kosiborod MN, Martinez FA, O'Meara E, Ponikowski P, Schou M, Berg DD, Sabatine MS, Morrow DA, Jarolim P, Hammarstedt A, Sjostrand M, Langkilde AM, Solomon SD, Sattar N, Jhund PS, McMurray JJV. Association of Carbohydrate Antigen 125 on the Response to Dapagliflozin in Patients With Heart Failure. J Am Coll Cardiol. 2023 Jul 11;82(2):142-157. doi: 10.1016/j.jacc.2023.05.011.
PubMed 37407113
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.
PubMed 37318419
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.
PubMed 37220172
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.
PubMed 37211977
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.
PubMed 37210608
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.
PubMed 37039015
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.
PubMed 36881399
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.
PubMed 36811901

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Vericiguat and Reverse Remodeling Indices in Heart Failure
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Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of AC01 Compared to Placebo in Participants With Chronic Heart Failure
Heart Failure With Reduced Ejection Fraction (HFrEF)
Not yet recruiting
Yiqi Fumai Lyophilized Injection for Chronic Heart Failure Caused by Coronary Heart Disease
Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)

All Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03036124
Acronym / sponsor ID: DAPA-HF / D1699C00001
Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Keywords: HFrEF, Heart Failure (HF), Cardiovascular Events (CV), Phase III outcome trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,744 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 8 Feb 2017 (actual)
Primary completion: 17 Jul 2019 (actual)
Study completion: 17 Jul 2019 (actual)
First posted: 30 Jan 2017 (estimated)
Results: Posted 1 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: DapagliflozinPatients will be randomized 1:1 to either dapagliflozin or placebo.
Placebo	Placebo comparator	Drug: PlaceboPlacebo matching dapagliflozin.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DapagliflozinAlso: Forxiga TM, Farxiga TM10 mg or 5 mg tablets given once daily, per oral use.	Drug	Dapagliflozin
PlaceboPlacebo matching dapagliflozin 10 mg or 5 mg.	Drug	Placebo

Primary outcome

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

5 secondary outcomes

Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
Time frame: Up to 27.8 months.
Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
Time frame: Up to 27.8 months.
Change From Baseline in the KCCQ Total Symptom Score
Time frame: 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.
Time frame: Up to 27.8 months.
Subjects Included in the Endpoint of All-cause Mortality.
Time frame: Up to 27.8 months.

Results and safety

Results posted to the registry on 1 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapa 10mg	2,373	2,368
Placebo	2,371	2,365

Primary outcome: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.

Time frame: Up to 27.8 months.. Count of participants. Unit: Participants

Measure	Dapa 10 mg n = 2373	Placebo n = 2371
Value	386	502

Placebo: Hazard Ratio (HR): 0.74 (95% CI 0.65 to 0.85), p <0.0001, Regression, Cox

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28.3 months.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapa 10mg	895 of 2,368 (37.8%)	299 of 2,368 (12.6%)	286 of 2,368
Placebo	994 of 2,368 (42%)	325 of 2,368 (13.7%)	333 of 2,368

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41170566Myte R, Mattsson A, Poole M, Little DJ, Nystrom P, Henderson A, Claggett BL, Gasparyan SB, Solomon SD, McMurray JJV. Survival Odds to Minimize Risk Heterogeneity Bias in Heart Failure Trials: Application to Dapagliflozin. Circ Heart Fail. 2025 Dec;18(12):e013496. doi: 10.1161/CIRCHEARTFAILURE.125.013496. Epub 2025 Oct 31.
Derived from this study: PubMed 40465275McDowell K, Welsh P, Docherty KF, Morrow DA, Jhund PS, De Boer RA, O'Meara E, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Hammarstedt A, Langkilde AM, Solomon SD, Sattar N, Sabatine MS, McMurray JJV. Cellular Adhesion Molecules and Adverse Outcomes in Chronic Heart Failure: Findings From the DAPA-HF Randomized Clinical Trial. JAMA Cardiol. 2025 Aug 1;10(8):797-808. doi: 10.1001/jamacardio.2025.1592.
Derived from this study: PubMed 40088234Docherty KF, McDowell K, Welsh P, Petrie MC, Anand I, Berg DD, de Boer RA, Kober L, Kosiborod MN, Martinez FA, O'Meara E, Morrow DA, Ponikowski P, Sabatine MS, Sattar N, Schou M, Hammarstedt A, Sjostrand M, Langkilde AM, Jhund PS, Solomon SD, McMurray JJV. Interleukin-6 in Heart Failure With Reduced Ejection Fraction and the Effect of Dapagliflozin: An Exploratory Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial. JACC Heart Fail. 2025 Jul;13(7):102393. doi: 10.1016/j.jchf.2024.12.012. Epub 2025 Mar 12.
Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Derived from this study: PubMed 38537918Kondo T, Mogensen UM, Talebi A, Gasparyan SB, Campbell RT, Docherty KF, de Boer RA, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Sabatine MS, Bengtsson O, Sjostrand M, Vaduganathan M, Solomon SD, Jhund PS, McMurray JJV. Dapagliflozin and Days of Full Health Lost in the DAPA-HF Trial. J Am Coll Cardiol. 2024 May 21;83(20):1973-1986. doi: 10.1016/j.jacc.2024.03.385. Epub 2024 Mar 25.
Derived from this study: PubMed 38320525Kondo T, Gasparyan SB, Jhund PS, Bengtsson O, Claggett BL, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Kober L, Lam CSP, Langkilde AM, Martinez FA, Petersson M, Ponikowski P, Sabatine MS, Shah SJ, Sjostrand M, Wilderang U, Vaduganathan M, Solomon SD, McMurray JJV. Use of Win Statistics to Analyze Outcomes in the DAPA-HF and DELIVER Trials. NEJM Evid. 2023 Nov;2(11):EVIDoa2300042. doi: 10.1056/EVIDoa2300042. Epub 2023 Oct 24.
Derived from this study: PubMed 37886880Kondo T, Butt JH, Curtain JP, Jhund PS, Docherty KF, Claggett BL, Vaduganathan M, Bachus E, Hernandez AF, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Kosiborod MN, Desai AS, Kober L, Ponikowski P, Sabatine MS, Solomon SD, McMurray JJV. Efficacy of Dapagliflozin According to Heart Rate: A Patient-Level Pooled Analysis of DAPA-HF and DELIVER. Circ Heart Fail. 2023 Dec;16(12):e010898. doi: 10.1161/CIRCHEARTFAILURE.123.010898. Epub 2023 Oct 27.
Derived from this study: PubMed 37407113Docherty KF, McDowell K, Welsh P, Osmanska J, Anand I, de Boer RA, Kober L, Kosiborod MN, Martinez FA, O'Meara E, Ponikowski P, Schou M, Berg DD, Sabatine MS, Morrow DA, Jarolim P, Hammarstedt A, Sjostrand M, Langkilde AM, Solomon SD, Sattar N, Jhund PS, McMurray JJV. Association of Carbohydrate Antigen 125 on the Response to Dapagliflozin in Patients With Heart Failure. J Am Coll Cardiol. 2023 Jul 11;82(2):142-157. doi: 10.1016/j.jacc.2023.05.011.
Derived from this study: PubMed 37318419Butt 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.
Derived from this study: PubMed 37220172Butt 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.
Derived from this study: PubMed 37211977Bhatt 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.
Derived from this study: PubMed 37210608Chatur 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.
redacted protocolLink provided by the sponsor.
redacted Statistical Analysis PlanLink provided by the sponsor.

Related trials for Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

419 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Chronic Heart Failure With Reduced Ejection Fraction (HFrEF), run by AstraZeneca at 419 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 419 sites in United States, Japan, China, Canada, Argentina and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure. (time frame: Up to 27.8 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03036124, which also lists 52 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.