Clinical trial NCT03036124: Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Keywords: HFrEF
Heart Failure (HF)
Cardiovascular Events (CV)
Phase III outcome trial
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-01-30
Enrollment: 4744
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures
* Male or female, aged ≥18 years
* Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
* LVEF≤40%
* Elevated NT-proBNP levels
* Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
* eGFR ≥30 mL/min/1.73 m\^2 (CKD-EPI formula) at enrolment (visit 1)

Exclusion Criteria:

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

Primary outcomes:
measure: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
timeFrame: Up to 27.8 months.
Secondary outcomes:
measure: Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
timeFrame: Up to 27.8 months.
measure: Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
timeFrame: Up to 27.8 months.
measure: Change From Baseline in the KCCQ Total Symptom Score
timeFrame: Baseline and 8 months or death before 8 months
measure: Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.
timeFrame: Up to 27.8 months.
measure: Subjects Included in the Endpoint of All-cause Mortality.
timeFrame: Up to 27.8 months.
Other outcomes:
Locations:
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facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Sneek
country: Netherlands
facility: Research Site
city: Veldhoven
country: Netherlands
facility: Research Site
city: Bochnia
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Jasło
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Kędzierzyn Koźle
country: Poland
facility: Research Site
city: Legnica
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Oława
country: Poland
facility: Research Site
city: Płock
country: Poland
facility: Research Site
city: Sokółka
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Wierzchosławice
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Gatchina
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Yekaterinburg
country: Russian Federation
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Svidnik
country: Slovakia
facility: Research Site
city: Trebisov
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Ostersund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Changhua City
country: Taiwan
facility: Research Site
city: Hsinchu
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kweishan Shiang
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Airdrie
country: United Kingdom
facility: Research Site
city: Clydebank
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Inverness
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Paisley
country: United Kingdom
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Hcmc
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Docherty KF, Jhund PS, Anand I, Bengtsson O, Bohm M, de Boer RA, DeMets DL, Desai AS, Drozdz J, Howlett J, Inzucchi SE, Johanson P, Katova T, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Martinez FA, Merkely B, Nicolau JC, O'Meara E, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Tereshchenko S, Verma S, McMurray JJV. Effect of Dapagliflozin on Outpatient Worsening of Patients With Heart Failure and Reduced Ejection Fraction: A Prespecified Analysis of DAPA-HF. Circulation. 2020 Oct 27;142(17):1623-1632. doi: 10.1161/CIRCULATIONAHA.120.047480. Epub 2020 Sep 4.
citation: Serenelli M, Bohm M, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, DeMets DL, Bengtsson O, Sjostrand M, Langkilde AM, Anand IS, Chiang CE, Chopra VK, de Boer RA, Diez M, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Verma S, Docherty KF, Jhund PS, McMurray JJV. Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF). Eur Heart J. 2020 Sep 21;41(36):3402-3418. doi: 10.1093/eurheartj/ehaa496.
citation: Jackson AM, Dewan P, Anand IS, Belohlavek J, Bengtsson O, de Boer RA, Bohm M, Boulton DW, Chopra VK, DeMets DL, Docherty KF, Dukat A, Greasley PJ, Howlett JG, Inzucchi SE, Katova T, Kober L, Kosiborod MN, Langkilde AM, Lindholm D, Ljungman CEA, Martinez FA, O'Meara E, Sabatine MS, Sjostrand M, Solomon SD, Tereshchenko S, Verma S, Jhund PS, McMurray JJV. Dapagliflozin and Diuretic Use in Patients With Heart Failure and Reduced Ejection Fraction in DAPA-HF. Circulation. 2020 Sep 15;142(11):1040-1054. doi: 10.1161/CIRCULATIONAHA.120.047077. Epub 2020 Jul 16.
citation: Solomon SD, Jhund PS, Claggett BL, Dewan P, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Inzucchi SE, Desai AS, Bengtsson O, Lindholm D, Sjostrand M, Langkilde AM, McMurray JJV. Effect of Dapagliflozin in Patients With HFrEF Treated With Sacubitril/Valsartan: The DAPA-HF Trial. JACC Heart Fail. 2020 Oct;8(10):811-818. doi: 10.1016/j.jchf.2020.04.008. Epub 2020 Jul 8.
citation: Dewan P, Solomon SD, Jhund PS, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, DeMets DL, Sabatine MS, Bengtsson O, Sjostrand M, Langkilde AM, Anand IS, Belohlavek J, Chopra VK, Dukat A, Kitakaze M, Merkely B, O'Meara E, Schou M, Vinh PN, McMurray JJV; DAPA-HF Investigators and Committees. Efficacy and safety of sodium-glucose co-transporter 2 inhibition according to left ventricular ejection fraction in DAPA-HF. Eur J Heart Fail. 2020 Jul;22(7):1247-1258. doi: 10.1002/ejhf.1867. Epub 2020 Jun 15.
citation: Petrie MC, Verma S, Docherty KF, Inzucchi SE, Anand I, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett J, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Vinh PN, Schou M, Tereshchenko S, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD, Johanson P, Greasley PJ, Boulton D, Bengtsson O, Jhund PS, McMurray JJV. Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes. JAMA. 2020 Apr 14;323(14):1353-1368. doi: 10.1001/jama.2020.1906.
citation: Kosiborod MN, Jhund PS, Docherty KF, Diez M, Petrie MC, Verma S, Nicolau JC, Merkely B, Kitakaze M, DeMets DL, Inzucchi SE, Kober L, Martinez FA, Ponikowski P, Sabatine MS, Solomon SD, Bengtsson O, Lindholm D, Niklasson A, Sjostrand M, Langkilde AM, McMurray JJV. Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction: Results From the DAPA-HF Trial. Circulation. 2020 Jan 14;141(2):90-99. doi: 10.1161/CIRCULATIONAHA.119.044138. Epub 2019 Nov 17.
citation: Martinez FA, Serenelli M, Nicolau JC, Petrie MC, Chiang CE, Tereshchenko S, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Ponikowski P, Sabatine MS, DeMets DL, Dutkiewicz-Piasecka M, Bengtsson O, Sjostrand M, Langkilde AM, Jhund PS, McMurray JJV. Efficacy and Safety of Dapagliflozin in Heart Failure With Reduced Ejection Fraction According to Age: Insights From DAPA-HF. Circulation. 2020 Jan 14;141(2):100-111. doi: 10.1161/CIRCULATIONAHA.119.044133. Epub 2019 Nov 17.
citation: McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
citation: McMurray JJV, DeMets DL, Inzucchi SE, Kober L, Kosiborod MN, Langkilde AM, Martinez FA, Bengtsson O, Ponikowski P, Sabatine MS, Sjostrand M, Solomon SD; DAPA-HF Committees and Investigators. The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics. Eur J Heart Fail. 2019 Nov;21(11):1402-1411. doi: 10.1002/ejhf.1548. Epub 2019 Jul 15.
citation: Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.