NCT03036124

Brief 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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
4,744

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2017

Geographic Reach
20 countries

419 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 1, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

January 26, 2017

Results QC Date

July 6, 2020

Last Update Submit

August 31, 2020

Conditions

Keywords

HFrEFHeart Failure (HF)Cardiovascular Events (CV)Phase III outcome trial

Outcome Measures

Primary Outcomes (1)

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

    Primary efficacy

    Up to 27.8 months.

Secondary Outcomes (5)

  • Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.

    Up to 27.8 months.

  • Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.

    Up to 27.8 months.

  • Change From Baseline in the KCCQ Total Symptom Score

    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.

    Up to 27.8 months.

  • Subjects Included in the Endpoint of All-cause Mortality.

    Up to 27.8 months.

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Patients will be randomized 1:1 to either dapagliflozin or placebo.

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo matching dapagliflozin.

Drug: Placebo

Interventions

10 mg or 5 mg tablets given once daily, per oral use.

Also known as: Forxiga TM, Farxiga TM
Dapagliflozin

Placebo matching dapagliflozin 10 mg or 5 mg.

Placebo

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
  • Type 1 diabetes mellitus
  • Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
  • Current acute decompensated HF or hospitalization due to decompensated HF \<4 weeks prior to enrolment
  • MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
  • Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
  • Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
  • Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
  • HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
  • Symptomatic bradycardia or second or third degree heart block without a pacemaker
  • Severe (eGFR \<30 mL/min/1.73 m\^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (419)

Research Site

Fairhope, Alabama, 36532, United States

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Mobile, Alabama, 36608, United States

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Sheffield, Alabama, 35660, United States

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Bakersfield, California, 93309, United States

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Beverly Hills, California, 90211, United States

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Los Angeles, California, 90073, United States

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Palm Springs, California, 92262, United States

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Stockton, California, 95204, United States

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Torrance, California, 90502, United States

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Vista, California, 92083, United States

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Wilmington, Delaware, 19803, United States

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Boynton Beach, Florida, 33472, United States

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Jacksonville, Florida, 32209, United States

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Jacksonville, Florida, 32216, United States

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Lake Worth, Florida, 33461, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33155, United States

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Naples, Florida, 34102, United States

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New Smyrna Beach, Florida, 32169, United States

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Pembroke Pines, Florida, 33024, United States

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Port Charlotte, Florida, 33952, United States

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Saint Augustine, Florida, 32086, United States

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Wellington, Florida, 33449, United States

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Atlanta, Georgia, 30303, United States

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Cumming, Georgia, 30041, United States

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Tucker, Georgia, 30084, United States

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Hazel Crest, Illinois, 60429, United States

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Jerseyville, Illinois, 62052, United States

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Peoria, Illinois, 61614, United States

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Louisville, Kentucky, 40205, United States

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Alexandria, Louisiana, 71301, United States

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Chalmette, Louisiana, 70043, United States

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Bangor, Maine, 04401, United States

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Baltimore, Maryland, 21120, United States

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Baltimore, Maryland, 21228, United States

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Columbia, Maryland, 21044, United States

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Boston, Massachusetts, 02114, United States

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Haverhill, Massachusetts, 01830, United States

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Flint, Michigan, 48504, United States

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Flint, Michigan, 48532, United States

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Lansing, Michigan, 48910, United States

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Minneapolis, Minnesota, 55407, United States

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Minneapolis, Minnesota, 55417, United States

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Tupelo, Mississippi, 38801, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63128, United States

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Great Falls, Montana, 59405, United States

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Grand Island, Nebraska, 68803, United States

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Lincoln, Nebraska, 68526, United States

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Omaha, Nebraska, 68105, United States

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Las Vegas, Nevada, 89128, United States

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Bridgewater, New Jersey, 08807, United States

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New Brunswick, New Jersey, 08901, United States

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Somerset, New Jersey, 08873, United States

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Buffalo, New York, 14203, United States

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Buffalo, New York, 14215, United States

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Cortlandt Manor, New York, 10567, United States

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New York, New York, 10001, United States

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Orchard Park, New York, 14127, United States

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Poughkeepsie, New York, 12601, United States

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Rosedale, New York, 11422, United States

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The Bronx, New York, 10459, United States

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Burlington, North Carolina, 27215, United States

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Cleveland, Ohio, 44106-6010, United States

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Columbus, Ohio, 43210, United States

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Altoona, Pennsylvania, 16602, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Pittsburgh, Pennsylvania, 15240, United States

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Rapid City, South Dakota, 57701, United States

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Knoxville, Tennessee, 37912, United States

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Memphis, Tennessee, 38104, United States

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Nashville, Tennessee, 37212, United States

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Tullahoma, Tennessee, 37388, United States

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Beaumont, Texas, 77702, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77002, United States

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Kingwood, Texas, 77339, United States

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San Antonio, Texas, 78234, United States

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Tyler, Texas, 75701, United States

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Farmington, Utah, 84025, United States

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Falls Church, Virginia, 22042, United States

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Richmond, Virginia, 23298, United States

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Seattle, Washington, 98101, United States

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Seattle, Washington, 98195, United States

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Buenos Aires, C1180AAX, Argentina

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Buenos Aires, C1425AGC, Argentina

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CABA, 1428, Argentina

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CABA, 1437, Argentina

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CABA, C1119ACN, Argentina

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CABA, C1120AAC, Argentina

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Caba, C1425DQI, Argentina

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Ciudad Autonoma Buenos Aires, 1093, Argentina

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Ciudad Autonoma de Buenos Aire, C1407GTN, Argentina

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Ciudad de Buenos Aires, 1221, Argentina

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Corrientes, W3400AMZ, Argentina

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Córdoba, 5003, Argentina

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Córdoba, X5004BAL, Argentina

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Córdoba, X5006CBI, Argentina

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Esperanza, S3080BQU, Argentina

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Mar del Plata, 7600, Argentina

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Mar del Plata, B7600FZN, Argentina

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Quilmes, B1878DVB, Argentina

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Quilmes, B1878GEG, Argentina

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Ramos Mejía, B1704ETD, Argentina

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Rosario, 2000, Argentina

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Rosario, S2000CVD, Argentina

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San Luis, 5700, Argentina

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San Martín, 1650, Argentina

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San Miguel de Tucumán, 4000, Argentina

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San Nicolás, B2900DMH, Argentina

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Santa Fe, S3000FWO, Argentina

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Vicente López, 1638, Argentina

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Belo Horizonte, 30140 062, Brazil

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Belo Horizonte, 30150-240, Brazil

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Brasillia, 70200-730, Brazil

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Brasília, 71625-175, Brazil

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Campina Grande do Sul, 83430000, Brazil

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Campinas, 13060-080, Brazil

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Curitiba, 80730-150, Brazil

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Goiânia, 74605050, Brazil

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Marília, 17515-000, Brazil

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Porto Alegre, 90020-090, Brazil

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Porto Alegre, 90035-903, Brazil

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Porto Alegre, 90620-001, Brazil

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Porto Alegre, 90840-440, Brazil

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Porto Alegre, 91350-200, Brazil

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Rio de Janeiro, 22271-100, Brazil

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São José do Rio Preto, 15090-000, Brazil

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São Paulo, 05403-000, Brazil

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Uberlândia, 38411-186, Brazil

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Votuporanga, 15500-003, Brazil

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Blagoevgrad, 2700, Bulgaria

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Dimitrovgrad, 6400, Bulgaria

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Haskovo, Bulgaria

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Kyustendil, 2500, Bulgaria

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Lom, 3600, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Plovdiv, 4001, Bulgaria

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Plovdiv, 4002, Bulgaria

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Plovdiv, 4003, Bulgaria

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Sofia, 1309, Bulgaria

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Sofia, 1408, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1463, Bulgaria

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Sofia, 1527, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1750, Bulgaria

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Calgary, Alberta, T2N 4Z6, Canada

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Abbotsford, British Columbia, V2S 3N2, Canada

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New Westminster, British Columbia, V3L 3W4, Canada

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North Vancouver, British Columbia, V7M 2H4, Canada

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Moncton, New Brunswick, E1C 2Z3, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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Brampton, Ontario, L6W 2X7, Canada

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Cambridge, Ontario, N1R 6V6, Canada

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Cambridge, Ontario, N1R 7R1, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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London, Ontario, N6A 5A5, Canada

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Newmarket, Ontario, L3Y 2P6, Canada

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North York, Ontario, M6B 3H7, Canada

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Oakville, Ontario, L6K 3W7, Canada

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Oshawa, Ontario, L1J 2K1, Canada

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Peterborough, Ontario, K9J 0B2, Canada

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Port Perry, Ontario, L9L 1L1, Canada

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Scarborough Village, Ontario, M1B 4Z8, Canada

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Scarborough Village, Ontario, M1E 5E9, Canada

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Waterloo, Ontario, N2T 0C1, Canada

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York, Ontario, M9N 1W4, Canada

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Greenfield Park, Quebec, J4V 2G8, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H1T 3Y7, Canada

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Montreal, Quebec, H2X 0A9, Canada

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Québec, Quebec, G1V 4G5, Canada

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Rimouski, Quebec, G5L 5T1, Canada

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Saint-Jérôme, Quebec, J7Z 5T3, Canada

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Terrebonne, Quebec, J6V 2H2, Canada

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Baotou, 014010, China

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Beijing, 100029, China

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Beijing, China

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Bengbu, 233060, China

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Changchun, 130021, China

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Changsha, 410011, China

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Chifeng, 024000, China

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Dalian, 116011, China

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Guangzhou, 510080, China

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Haerbin, 150001, China

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Lanzhou, 730030, China

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Nanchang, 330006, China

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Nanjing, 210009, China

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Nanjing, 210029, China

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Ningbo, 315010, China

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Pingxiang, 337055, China

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Shanghai, 200025, China

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Shanghai, 200032, China

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Shanghai, 200062, China

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Shanghai, 200090, China

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Shanghai, 200120, China

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Shenyang, 110001, China

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Shenzhen, 518036, China

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Tianjin, 300211, China

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Wuhan, 430033, China

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Wuhan, 430060, China

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Xuzhou, 221006, China

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Xuzhou, 221009, China

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Yinchuan, 750004, China

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Zhuhai, 519000, China

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Benešov, 256 01, Czechia

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Brno, 62500, Czechia

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Brno, 656 91, Czechia

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Kolín, 280 00, Czechia

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Louny, 440 01, Czechia

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Ostrava-Dubina, 700 30, Czechia

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Pilsen, 320 00, Czechia

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Prague, 12808, Czechia

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Prague, 140 00, Czechia

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Prague, 140 59, Czechia

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Prague, 150 00, Czechia

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Třebíč, 674 01, Czechia

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Hellerup, 2900, Denmark

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Herlev, 2730, Denmark

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Hvidovre, 2650, Denmark

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København Ø, 2100, Denmark

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Odense C, 5000, Denmark

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Svendborg, DK-5700, Denmark

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Bad Oeynhausen, 32545, Germany

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Berlin, 13347, Germany

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Berlin, 13597, Germany

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Dresden, 01099, Germany

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Dresden, 01307, Germany

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Hamburg, 22041, Germany

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Homburg, 66424, Germany

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Kassel, 34121, Germany

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Leipzig, 04107, Germany

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Mainz, 55131, Germany

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Papenburg, 26871, Germany

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Stuttgart, 70199, Germany

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Wermsdorf, 04779, Germany

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Budapest, 1115, Hungary

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Budapest, 1122, Hungary

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Budapest, 1135, Hungary

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Budapest, 1139, Hungary

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Budapest, H-1106, Hungary

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Kecskemét, 6000, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Szentes, 6600, Hungary

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Székesfehérvár, 8000, Hungary

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Zalaegerszeg, 8900, Hungary

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Ahmedabad, 380060, India

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Aurangabad, 431003, India

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Bangalore, 560074, India

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Belagavi, 590010, India

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Ernākulam, 683594, India

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Gūrgaon, 122001, India

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Kanpur, 208002, India

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Karamsad, 388345, India

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Kolkata, 700020, India

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Maharashtra, 411013, India

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Nadiād, 387002, India

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Nagpur, 420012, India

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Nagpur, 440003, India

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New Delhi, 110002, India

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Pune, 411001, India

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Pune, 411011, India

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Adachi-ku, 123-0845, Japan

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Aki-gun,, 735-8585, Japan

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Azumino-shi, 399-8292, Japan

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Beppu-shi, 874-0011, Japan

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Bunkyō City, 113-8431, Japan

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Chikushino-shi, 818-8516, Japan

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Chūōku, 103-0027, Japan

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Chūōku, 104-8560, Japan

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Fujisawa-shi, 251-0041, Japan

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Fujisawa-shi, 251-8550, Japan

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Fukuoka, 815-8555, Japan

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Hachioji-shi, 192-0918, Japan

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Hamamatsu, 430-0929, Japan

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Himeji-shi, 670-0981, Japan

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Hiratsuka-shi, 254-8502, Japan

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Hitachi-Naka, 312-0057, Japan

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Iizuka-shi, 820-8505, Japan

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Itabashi-ku, 173-8610, Japan

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Iwakuni-shi, 740-8510, Japan

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Kagoshima, 890-8520, Japan

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Kakamigahara-shi, 504-8601, Japan

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Kasama-shi, 309-1793, Japan

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Kishiwada-shi, 596-8522, Japan

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Kitakyusyu-shi, 806-8501, Japan

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Kumamoto, 860-0008, Japan

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Kure-shi, 737-0023, Japan

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Kusatsu-shi, 525-8585, Japan

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Kyoto, 601-1434, Japan

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Matsudo-shi, 270-2251, Japan

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Matsudo-shi, 271-0077, Japan

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Matsumoto-shi, 390-8621, Japan

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Matsuyama, 790-0067, Japan

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Meguro-ku, 152-8902, Japan

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Mito, 311-4198, Japan

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Miura-gun, 240-0116, Japan

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Nagasaki, 850-8555, Japan

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Nagoya, 453-8511, Japan

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Nagoya, 455-8530, Japan

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Nagoya, 457-8511, Japan

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Nagoya, 460-0001, Japan

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Nishinomiya-shi, 663-8501, Japan

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Okayama, 700-0804, Japan

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Osaka, 530-0001, Japan

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Osaka, 540-0006, Japan

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Sagamihara-shi, 252-5188, Japan

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Sakai-shi,Kita-ku, 591-8025, Japan

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Sakaide-shi, 762-0007, Japan

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Sanyoonoda-shi, 756-0095, Japan

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Sayama-shi, 350-1305, Japan

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Sendai, 980-0803, Japan

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Sendai, 983-0045, Japan

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Shimonoseki-shi, 750-0061, Japan

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Shinjuku-ku, 169-0073, Japan

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Suita-shi, 564-8565, Japan

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Suwa-shi, 392-8510, Japan

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Tachikawa-shi, 190-8531, Japan

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Takamatsu, 760-0018, Japan

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Takasaki-shi, 370-0829, Japan

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Toride-shi, 302-0022, Japan

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Tsuchiura-shi, 300-0028, Japan

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Tsukuba, 305-0005, Japan

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Ueda-shi, 386-8610, Japan

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Wakayama, 640-8505, Japan

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Wakayama, 649-6335, Japan

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Wako-shi, 351-0102, Japan

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Yokohama, 236-0051, Japan

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's-Hertogenbosch, 5223 GZ, Netherlands

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Apeldoorn, 7334 DZ, Netherlands

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Gouda, 2803 HH, Netherlands

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Groningen, 9713 GZ, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Rotterdam, 3045 PM, Netherlands

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Rotterdam, 3083 AN, Netherlands

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Sneek, 8601 ZR, Netherlands

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The Hague, 2545 AA, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Bochnia, 32-700, Poland

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Gdynia, 81-423, Poland

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Jasło, 38-200, Poland

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Katowice, 40-081, Poland

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Kędzierzyn-Koźle, 47-200, Poland

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Krakow, 30-082, Poland

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Legnica, 59-220, Poland

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Lodz, 92-213, Poland

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Lublin, 20-044, Poland

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Oława, 55-200, Poland

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Płock, 09-402, Poland

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Sokółka, 16-100, Poland

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Torun, 87-100, Poland

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Wierzchosławice, 33-122, Poland

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Gatchina, 188300, Russia

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Izhevsk, 426063, Russia

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Kazan', 420012, Russia

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Moscow, 109263, Russia

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Moscow, 119435, Russia

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Moscow, 121551, Russia

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Moscow, 121552, Russia

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Novosibirsk, 630055, Russia

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Perm, 6144090, Russia

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Ryazan, 390039, Russia

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Saint Petersburg, 192283, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 194354, Russia

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Saint Petersburg, 195067, Russia

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Saint Petersburg, 196084, Russia

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Saint Petersburg, 196601, Russia

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Saint Petersburg, 198260, Russia

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Tver', 170036, Russia

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Yekaterinburg, 620039, Russia

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Yekaterinburg, 620102, Russia

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Brezno, 97742, Slovakia

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Košice, 040 01, Slovakia

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Lučenec, 984 01, Slovakia

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Martin, 036 01, Slovakia

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Nové Zámky, 94001, Slovakia

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Prešov, 080 01, Slovakia

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Svidník, 08901, Slovakia

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Trebišov, 075 01, Slovakia

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Trnava, 917 01, Slovakia

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Žilina, 010 01, Slovakia

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Gothenburg, 413 45, Sweden

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Lund, 222 21, Sweden

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Östersund, 831 83, Sweden

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Stockholm, 118 83, Sweden

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Umeå, 90737, Sweden

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Changhua, 50006, Taiwan

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Hsinchu, 300, Taiwan

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, Taiwan

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Kweishan Shiang, 333, Taiwan

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Taichung, 40705, Taiwan

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Taichung, Taiwan

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Tainan, 70403, Taiwan

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Tainan, 710, Taiwan

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Taipei, 11217, Taiwan

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Taipei, 11220, Taiwan

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Taipei, Taiwan

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Airdrie, ML6 0JS, United Kingdom

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Clydebank, G81 4DY, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Edinburgh, EH16 4SA, United Kingdom

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Glasgow, G31 2ER, United Kingdom

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Glasgow, G51 4TF, United Kingdom

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Inverness, IV2 3JH, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Paisley, PA2 9PN, United Kingdom

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Hanoi, 100000, Vietnam

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Hanoi, Vietnam

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Ho Chi Minh City, 7000000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Ho Chi Minh City, 70000, Vietnam

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Ho Chi Minh City, Vietnam

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Related Publications (52)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Butt JH, Docherty KF, Kosiborod MN, Inzucchi SE, Kober L, Langkilde AM, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon S, Jhund PS, McMurray JJV. Dapagliflozin and Physical and Social Activity Limitations in Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2023 Oct;11(10):1411-1423. doi: 10.1016/j.jchf.2023.04.016. Epub 2023 Jun 14.

  • Butt JH, Kondo T, Yang M, Jhund PS, Docherty KF, Vaduganathan M, Claggett BL, Hernandez AF, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Kosiborod MN, Desai AS, Kober L, Ponikowski P, Sabatine MS, Shah SJ, Zaozerska N, Wilderang U, Bengtsson O, Solomon SD, McMurray JJV. Heart failure, peripheral artery disease, and dapagliflozin: a patient-level meta-analysis of DAPA-HF and DELIVER. Eur Heart J. 2023 Jun 25;44(24):2170-2183. doi: 10.1093/eurheartj/ehad276.

  • Bhatt AS, Kosiborod MN, Vaduganathan M, Claggett BL, Miao ZM, Kulac IJ, Lam CSP, Hernandez AF, Martinez F, Inzucchi SE, Shah SJ, de Boer RA, Jhund PS, Desai AS, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Effect of dapagliflozin on health status and quality of life across the spectrum of ejection fraction: Participant-level pooled analysis from the DAPA-HF and DELIVER trials. Eur J Heart Fail. 2023 Jul;25(7):981-988. doi: 10.1002/ejhf.2909. Epub 2023 Jun 7.

  • Chatur S, Kondo T, Claggett BL, Docherty K, Miao ZM, Desai AS, Jhund PS, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez FA, Shah SJ, Petersson M, Langkilde AM, McMurray JJV, Solomon SD, Vaduganathan M. Effects of dapagliflozin on heart failure hospitalizations according to severity of inpatient course: Insights from DELIVER and DAPA-HF. Eur J Heart Fail. 2023 Aug;25(8):1364-1371. doi: 10.1002/ejhf.2912. Epub 2023 Jun 8.

  • Yeoh SE, Docherty KF, Campbell RT, Jhund PS, Hammarstedt A, Heerspink HJL, Jarolim P, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Solomon SD, Sjostrand M, Bengtsson O, Greasley PJ, Sattar N, Welsh P, Sabatine MS, Morrow DA, McMurray JJV. Endothelin-1, Outcomes in Patients With Heart Failure and Reduced Ejection Fraction, and Effects of Dapagliflozin: Findings From DAPA-HF. Circulation. 2023 May 30;147(22):1670-1683. doi: 10.1161/CIRCULATIONAHA.122.063327. Epub 2023 Apr 11.

  • Butt JH, Docherty KF, Claggett BL, Desai AS, Fang JC, Petersson M, Langkilde AM, de Boer RA, Cabrera Honorio JW, Hernandez AF, Inzucchi SE, Kosiborod MN, Kober L, Lam CSP, Martinez FA, Ponikowski P, Sabatine MS, Vardeny O, O'Meara E, Saraiva JFK, Shah SJ, Vaduganathan M, Jhund PS, Solomon SD, McMurray JJV. Dapagliflozin in Black and White Patients With Heart Failure Across the Ejection Fraction Spectrum. JACC Heart Fail. 2023 Apr;11(4):375-388. doi: 10.1016/j.jchf.2022.11.014. Epub 2023 Feb 1.

  • Butt JH, Docherty KF, Claggett BL, Desai AS, Petersson M, Langkilde AM, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Kober L, Lam CSP, Martinez FA, Ponikowski P, Sabatine MS, Shah SJ, Vaduganathan M, Jhund PS, Solomon SD, McMurray JJV. Association of Dapagliflozin Use With Clinical Outcomes and the Introduction of Uric Acid-Lowering Therapy and Colchicine in Patients With Heart Failure With and Without Gout: A Patient-Level Pooled Meta-analysis of DAPA-HF and DELIVER. JAMA Cardiol. 2023 Apr 1;8(4):386-393. doi: 10.1001/jamacardio.2022.5608.

  • Adamson C, Welsh P, Docherty KF, de Boer RA, Diez M, Drozdz J, Dukat A, Inzucchi SE, Kober L, Kosiborod MN, Ljungman CEA, Martinez FA, Ponikowski P, Sabatine MS, Morrow DA, Lindholm D, Hammarstedt A, Boulton DW, Greasley PJ, Langkilde AM, Solomon SD, Sattar N, McMurray JJV, Jhund PS. IGFBP-7 and Outcomes in Heart Failure With Reduced Ejection Fraction: Findings From DAPA-HF. JACC Heart Fail. 2023 Mar;11(3):291-304. doi: 10.1016/j.jchf.2022.09.004. Epub 2022 Nov 9.

  • Docherty KF, Anand IS, Chiang CE, Chopra VK, Desai AS, Kitakaze M, Verma S, Vinh PN, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Langkilde AM, Jhund PS, McMurray JJV. Effects of Dapagliflozin in Asian Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF. JACC Asia. 2022 Mar 29;2(2):139-153. doi: 10.1016/j.jacasi.2022.02.004. eCollection 2022 Apr.

  • Desai AS, Jhund PS, Claggett BL, Vaduganathan M, Miao ZM, Kondo T, Barkoudah E, Brahimi A, Connolly E, Finn P, Lang NN, Mc Causland FR, McGrath M, Petrie MC, McMurray JJV, Solomon SD. Effect of Dapagliflozin on Cause-Specific Mortality in Patients With Heart Failure Across the Spectrum of Ejection Fraction: A Participant-Level Pooled Analysis of DAPA-HF and DELIVER. JAMA Cardiol. 2022 Dec 1;7(12):1227-1234. doi: 10.1001/jamacardio.2022.3736.

  • Adamson C, Cowan LM, de Boer RA, Diez M, Drozdz J, Dukat A, Inzucchi SE, Kober L, Kosiborod MN, Ljungman CEA, Martinez FA, Ponikowski P, Sabatine MS, Lindholm D, Bengtsson O, Boulton DW, Greasley PJ, Langkilde AM, Sjostrand M, Solomon SD, McMurray JJV, Jhund PS. Liver tests and outcomes in heart failure with reduced ejection fraction: findings from DAPA-HF. Eur J Heart Fail. 2022 Oct;24(10):1856-1868. doi: 10.1002/ejhf.2649. Epub 2022 Aug 22.

  • Docherty KF, Welsh P, Verma S, De Boer RA, O'Meara E, Bengtsson O, Kober L, Kosiborod MN, Hammarstedt A, Langkilde AM, Lindholm D, Little DJ, Sjostrand M, Martinez FA, Ponikowski P, Sabatine MS, Morrow DA, Schou M, Solomon SD, Sattar N, Jhund PS, McMurray JJV; DAPA-HF Investigators and Committees. Iron Deficiency in Heart Failure and Effect of Dapagliflozin: Findings From DAPA-HF. Circulation. 2022 Sep 27;146(13):980-994. doi: 10.1161/CIRCULATIONAHA.122.060511. Epub 2022 Aug 16.

  • Butt JH, Dewan P, DeFilippis EM, Biering-Sorensen T, Docherty KF, Jhund PS, Kosiborod MN, Martinez FA, Bengtsson O, Johansen ND, Langkilde AM, Sjostrand M, Vaduganathan M, Solomon SD, Sabatine MS, Kober L, Fiuzat M, McMurray JJV. Effects of Dapagliflozin According to the Heart Failure Collaboratory Medical Therapy Score: Insights From DAPA-HF. JACC Heart Fail. 2022 Aug;10(8):543-555. doi: 10.1016/j.jchf.2022.03.009. Epub 2022 Jun 8.

  • Yeoh SE, Docherty KF, Jhund PS, Petrie MC, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Boulton DW, Greasley PJ, Langkilde AM, Sjostrand M, Solomon SD, McMurray JJV. Relationship of Dapagliflozin With Serum Sodium: Findings From the DAPA-HF Trial. JACC Heart Fail. 2022 May;10(5):306-318. doi: 10.1016/j.jchf.2022.01.019. Epub 2022 Apr 6.

  • Butt JH, Dewan P, Merkely B, Belohlavek J, Drozdz J, Kitakaze M, Inzucchi SE, Kosiborod MN, Martinez FA, Tereshchenko S, Ponikowski P, Bengtsson O, Lindholm D, Langkilde AM, Schou M, Sjostrand M, Solomon SD, Sabatine MS, Chiang CE, Docherty KF, Jhund PS, Kober L, McMurray JJV. Efficacy and Safety of Dapagliflozin According to Frailty in Heart Failure With Reduced Ejection Fraction : A Post Hoc Analysis of the DAPA-HF Trial. Ann Intern Med. 2022 Jun;175(6):820-830. doi: 10.7326/M21-4776. Epub 2022 Apr 26.

  • Adamson C, Docherty KF, Heerspink HJL, de Boer RA, Damman K, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Petrie MC, Ponikowski P, Sabatine MS, Schou M, Solomon SD, Verma S, Bengtsson O, Langkilde AM, Sjostrand M, Vaduganathan M, Jhund PS, McMurray JJV. Initial Decline (Dip) in Estimated Glomerular Filtration Rate After Initiation of Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: Insights From DAPA-HF. Circulation. 2022 Aug 9;146(6):438-449. doi: 10.1161/CIRCULATIONAHA.121.058910. Epub 2022 Apr 20.

  • Docherty KF, Simpson J, Jhund PS, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Sjostrand M, Lindholm D, Langkilde AM, Solomon SD, McMurray JJV; DAPA-HF Investigators and Committees. Effect of Dapagliflozin, Compared With Placebo, According to Baseline Risk in DAPA-HF. JACC Heart Fail. 2022 Feb;10(2):104-118. doi: 10.1016/j.jchf.2021.09.002. Epub 2022 Jan 12.

  • Docherty KF, Ogunniyi MO, Anand IS, Desai AS, Diez M, Howlett JG, Nicolau JC, O'Meara E, Verma S, Inzucchi SE, Kober L, Kosiborod MN, Lindholm D, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Langkilde AM, Jhund PS, McMurray JJV. Efficacy of Dapagliflozin in Black Versus White Patients With Heart Failure and Reduced Ejection Fraction. JACC Heart Fail. 2022 Jan;10(1):52-64. doi: 10.1016/j.jchf.2021.08.006. Epub 2021 Nov 10.

  • Ryden L, Ferrannini G. Is the impact of add on heart failure therapy influenced by background therapy? Lancet Diabetes Endocrinol. 2022 Jan;10(1):3-5. doi: 10.1016/S2213-8587(21)00311-9. Epub 2021 Nov 30. No abstract available.

  • Butt JH, Adamson C, Docherty KF, de Boer RA, Petrie MC, Inzucchi SE, Kosiborod MN, Maria Langkilde A, Lindholm D, Martinez FA, Bengtsson O, Schou M, O'Meara E, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Jhund PS, McMurray JJV, Kober L. Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to N-Terminal Pro-B-Type Natriuretic Peptide: Insights From the DAPA-HF Trial. Circ Heart Fail. 2021 Dec;14(12):e008837. doi: 10.1161/CIRCHEARTFAILURE.121.008837. Epub 2021 Nov 22.

  • Berg DD, Docherty KF, Sattar N, Jarolim P, Welsh P, Jhund PS, Anand IS, Chopra V, de Boer RA, Kosiborod MN, Nicolau JC, O'Meara E, Schou M, Hammarstedt A, Langkilde AM, Lindholm D, Sjostrand M, McMurray JJV, Sabatine MS, Morrow DA. Serial Assessment of High-Sensitivity Cardiac Troponin and the Effect of Dapagliflozin in Patients With Heart Failure With Reduced Ejection Fraction: An Analysis of the DAPA-HF Trial. Circulation. 2022 Jan 18;145(3):158-169. doi: 10.1161/CIRCULATIONAHA.121.057852. Epub 2021 Nov 8.

  • Curtain JP, Docherty KF, Jhund PS, Petrie MC, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Langkilde AM, Sjostrand M, Solomon SD, McMurray JJV. Effect of dapagliflozin on ventricular arrhythmias, resuscitated cardiac arrest, or sudden death in DAPA-HF. Eur Heart J. 2021 Sep 21;42(36):3727-3738. doi: 10.1093/eurheartj/ehab560.

  • Docherty KF, Jhund PS, Claggett B, Ferreira JP, Bengtsson O, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, McMurray JJV; DAPA-HF Investigators and Committees. Extrapolating Long-term Event-Free and Overall Survival With Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis of a Phase 3 Randomized Clinical Trial. JAMA Cardiol. 2021 Nov 1;6(11):1298-1305. doi: 10.1001/jamacardio.2021.2632.

  • Adamson C, Jhund PS, Docherty KF, Belohlavek J, Chiang CE, Diez M, Drozdz J, Dukat A, Howlett J, Ljungman CEA, Petrie MC, Schou M, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Bengtsson O, Langkilde AM, Lindholm D, Sjostrand M, McMurray JJV. Efficacy of dapagliflozin in heart failure with reduced ejection fraction according to body mass index. Eur J Heart Fail. 2021 Oct;23(10):1662-1672. doi: 10.1002/ejhf.2308. Epub 2021 Jul 29.

  • Jhund PS, Ponikowski P, Docherty KF, Gasparyan SB, Bohm M, Chiang CE, Desai AS, Howlett J, Kitakaze M, Petrie MC, Verma S, Bengtsson O, Langkilde AM, Sjostrand M, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Sabatine MS, Solomon SD, McMurray JJV. Dapagliflozin and Recurrent Heart Failure Hospitalizations in Heart Failure With Reduced Ejection Fraction: An Analysis of DAPA-HF. Circulation. 2021 May 18;143(20):1962-1972. doi: 10.1161/CIRCULATIONAHA.121.053659. Epub 2021 Apr 9.

  • Butt JH, Docherty KF, Petrie MC, Schou M, Kosiborod MN, O'Meara E, Katova T, Ljungman CEA, Diez M, Ogunniyi MO, Langkilde AM, Sjostrand M, Lindholm D, Bengtsson O, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Jhund PS, McMurray JJV, Kober L. Efficacy and Safety of Dapagliflozin in Men and Women With Heart Failure With Reduced Ejection Fraction: A Prespecified Analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure Trial. JAMA Cardiol. 2021 Jun 1;6(6):678-689. doi: 10.1001/jamacardio.2021.0379.

  • Berg DD, Jhund PS, Docherty KF, Murphy SA, Verma S, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Bengtsson O, Ponikowski P, Sjostrand M, Solomon SD, McMurray JJV, Sabatine MS. Time to Clinical Benefit of Dapagliflozin and Significance of Prior Heart Failure Hospitalization in Patients With Heart Failure With Reduced Ejection Fraction. JAMA Cardiol. 2021 May 1;6(5):499-507. doi: 10.1001/jamacardio.2020.7585.

  • Shen L, Kristensen SL, Bengtsson O, Bohm M, de Boer RA, Docherty KF, Inzucchi SE, Katova T, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Martinez MFA, O'Meara E, Nicolau JC, Petrie MC, Ponikowski P, Sabatine MS, Schou M, Sjostrand M, Solomon SD, Jhund PS, McMurray JJV. Dapagliflozin in HFrEF Patients Treated With Mineralocorticoid Receptor Antagonists: An Analysis of DAPA-HF. JACC Heart Fail. 2021 Apr;9(4):254-264. doi: 10.1016/j.jchf.2020.11.009. Epub 2021 Feb 3.

  • Dewan P, Docherty KF, Bengtsson O, de Boer RA, Desai AS, Drozdz J, Hawkins NM, Inzucchi SE, Kitakaze M, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Martinez FA, Merkely B, Petrie MC, Ponikowski P, Sabatine MS, Schou M, Sjostrand M, Solomon SD, Verma S, Jhund PS, McMurray JJV. Effects of dapagliflozin in heart failure with reduced ejection fraction and chronic obstructive pulmonary disease: an analysis of DAPA-HF. Eur J Heart Fail. 2021 Apr;23(4):632-643. doi: 10.1002/ejhf.2083. Epub 2021 Jan 18.

  • Inzucchi SE, Docherty KF, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Verma S, Belohlavek J, Bohm M, Chiang CE, de Boer RA, Diez M, Dukat A, Ljungman CEA, Bengtsson O, Langkilde AM, Sjostrand M, Jhund PS, McMurray JJV; DAPA-HF Investigators and Committees. Dapagliflozin and the Incidence of Type 2 Diabetes in Patients With Heart Failure and Reduced Ejection Fraction: An Exploratory Analysis From DAPA-HF. Diabetes Care. 2021 Feb;44(2):586-594. doi: 10.2337/dc20-1675. Epub 2020 Dec 18.

  • Yeoh SE, Dewan P, Jhund PS, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Bengtsson O, Sjostrand M, Langkilde AM, McMurray JJV; DAPA-HF Investigators and Committees. Patient Characteristics, Clinical Outcomes, and Effect of Dapagliflozin in Relation to Duration of Heart Failure: Is It Ever Too Late to Start a New Therapy? Circ Heart Fail. 2020 Dec;13(12):e007879. doi: 10.1161/CIRCHEARTFAILURE.120.007879. Epub 2020 Nov 9.

  • Docherty KF, Jhund PS, Bengtsson O, DeMets DL, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Sabatine MS, Sjostrand M, Solomon SD, McMurray JJV; DAPA-HF Investigators and Committees. Effect of Dapagliflozin in DAPA-HF According to Background Glucose-Lowering Therapy. Diabetes Care. 2020 Nov;43(11):2878-2881. doi: 10.2337/dc20-1402. Epub 2020 Sep 2.

  • Jhund PS, Solomon SD, Docherty KF, Heerspink HJL, Anand IS, Bohm M, Chopra V, de Boer RA, Desai AS, Ge J, Kitakaze M, Merkley B, O'Meara E, Shou M, Tereshchenko S, Verma S, Vinh PN, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Bengtsson O, Langkilde AM, Sjostrand M, McMurray JJV. Efficacy of Dapagliflozin on Renal Function and Outcomes in Patients With Heart Failure With Reduced Ejection Fraction: Results of DAPA-HF. Circulation. 2021 Jan 26;143(4):298-309. doi: 10.1161/CIRCULATIONAHA.120.050391. Epub 2020 Oct 12.

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Related Links

MeSH Terms

Conditions

Heart Failure

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
AstraZeneca Clinical Study Information Center
Organization
AstraZeneca

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

February 8, 2017

Primary Completion

July 17, 2019

Study Completion

July 17, 2019

Last Updated

September 1, 2020

Results First Posted

September 1, 2020

Record last verified: 2020-08

Locations