Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
NCT ID: NCT03619213
Last Updated: 2023-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6263 participants
INTERVENTIONAL
2018-08-27
2022-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dapagliflozin
Patients will be randomized 1:1 to either dapagliflozin or placebo.
Dapagliflozin
10 mg tablets given once daily, per oral use.
Placebo
Placebo matching dapagliflozin.
Placebo
Placebo matching dapagliflozin 10 mg
Interventions
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Dapagliflozin
10 mg tablets given once daily, per oral use.
Placebo
Placebo matching dapagliflozin 10 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female patients age ≥40 years.
3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
4. Left Ventricular Ejection Fraction (LVEF) \>40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
5. Elevated NT-pro BNP levels.
6. Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.
Exclusion Criteria
2. Type 1 diabetes mellitus (T1D).
3. eGFR \<25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
4. Systolic blood pressure (BP) \<95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
5. Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
6. MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
7. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
8. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
9. Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
10. Body mass index \>50 kg/m2.
40 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Fairhope, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Tucson, Arizona, United States
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Saint Augustine, Florida, United States
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Gurnee, Illinois, United States
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Anderson, Indiana, United States
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Munster, Indiana, United States
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Louisville, Kentucky, United States
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Hammond, Louisiana, United States
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Houma, Louisiana, United States
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Monroe, Louisiana, United States
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Boston, Massachusetts, United States
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Bay City, Michigan, United States
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Flint, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Paul, Minnesota, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Great Falls, Montana, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Bridgewater, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Wilmington, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Rapid City, South Dakota, United States
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Jackson, Tennessee, United States
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Humble, Texas, United States
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Sherman, Texas, United States
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Burlington, Vermont, United States
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Falls Church, Virginia, United States
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Leesburg, Virginia, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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CABA, , Argentina
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Catamarca, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Corrientes, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Ramos Mejía, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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San Nicolás, , Argentina
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Santa Fe, , Argentina
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Aalst, , Belgium
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Brasschaat, , Belgium
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Brussels, , Belgium
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Huy, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Belo Horizonte, , Brazil
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Belo Horizonte, , Brazil
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Blumenau, , Brazil
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Campina Grande do Sul, , Brazil
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Campinas, , Brazil
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Dimitrovgrad, , Bulgaria
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Fuzhou, , China
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Guangzhou, , China
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Pingxiang, , China
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Wuhan, , China
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Xi'an, , China
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Kobe, , Japan
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Kyoto, , Japan
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Miura-gun, , Japan
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Ōita, , Japan
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Dammam, , Saudi Arabia
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A Coruña, , Spain
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Tainan City, , Taiwan
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Hanoi, , Vietnam
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References
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Ostrominski JW, Neuen BL, Claggett BL, Anand IS, Desai AS, Jhund PS, Lam CSP, Pfeffer MA, Pitt B, Zannad F, Zile MR, Packer M, Docherty KF, McMurray JJV, Solomon SD, Vaduganathan M. Natriuretic Peptides, Body Mass Index, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. J Am Coll Cardiol. 2025 Aug 27:S0735-1097(25)07493-5. doi: 10.1016/j.jacc.2025.08.028. Online ahead of print.
Siqueira SRO, Pabon MA, Vaduganathan M, Claggett BL, Lam CSP, Kosiborod MN, de Boer RA, Shah SJ, Fang JC, Desai AS, Jhund PS, Inzucchi SE, Martinez F, Hernandez AF, Petersson M, McMurray JJV, Solomon SD, Vardeny O. Achieved Ejection Fraction and Effects of Dapagliflozin in Heart Failure With Improved Ejection Fraction. JACC Heart Fail. 2025 Aug 18;13(10):102585. doi: 10.1016/j.jchf.2025.102585. Online ahead of print.
Inciardi RM, Vaduganathan M, Claggett B, AbouEzzeddine OF, Borlaug BA, Desai AS, Jhund PS, Lam CSP, Minamisawa M, Lewis EF, Redfield MM, Shah SJ, Fontana M, Pfeffer MA, McMurray JJV, Solomon SD. Application of a transthyretin amyloid cardiomyopathy score to heart failure with mildly reduced or preserved ejection fraction. Eur J Heart Fail. 2025 Jun 9. doi: 10.1002/ejhf.3698. Online ahead of print.
Inciardi RM, Lu H, Claggett BL, Desai AS, Jhund PS, Lam CSP, Kosiborod MN, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Kober L, Ponikowski P, Sabatine MS, Petersson M, Langkilde AM, McMurray JJV, Vaduganathan M, Solomon SD. Severe Heart Failure and Treatment With Dapagliflozin Across the Ejection Fraction Spectrum: DAPA-HF and DELIVER. JACC Heart Fail. 2025 Apr;13(4):618-627. doi: 10.1016/j.jchf.2024.11.023. Epub 2025 Mar 5.
Yang M, Kondo T, Talebi A, Jhund PS, Docherty KF, Claggett BL, Vaduganathan M, Bachus E, Hernandez AF, Lam CSP, Martinez FA, de Boer RA, Kosiborod MN, Desai AS, Kober L, Ponikowski P, Sabatine MS, Solomon SD, McMurray JJV. EuroQol 5-Dimension Questionnaire in Heart Failure With Reduced, Mildly Reduced, and Preserved Ejection Fraction: A Patient-Level Analysis of DAPA-HF and DELIVER. JACC Heart Fail. 2025 Feb;13(2):277-292. doi: 10.1016/j.jchf.2024.10.020.
Lu H, Kondo T, Claggett BL, Vaduganathan M, Neuen BL, Beldhuis IE, Jhund PS, Mc Causland FR, Anand IS, Pfeffer MA, Pitt B, Zannad F, Zile MR, McMurray JJV, Solomon SD, Desai AS. Systolic Blood Pressure and Pulse Pressure in Heart Failure: Pooled Participant-Level Analysis of 4 Trials. J Am Coll Cardiol. 2025 Feb 25;85(7):710-722. doi: 10.1016/j.jacc.2024.11.007. Epub 2024 Nov 15.
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.
Vardeny O, Desai AS, Jhund PS, Fang JC, Claggett B, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez FA, Shah SJ, Mc Causland FR, Petrie MC, Vaduganathan M, McMurray JJV, Solomon SD. Dapagliflozin and Mode of Death in Heart Failure With Improved Ejection Fraction: A Post Hoc Analysis of the DELIVER Trial. JAMA Cardiol. 2024 Mar 1;9(3):283-289. doi: 10.1001/jamacardio.2023.5318.
Mc Causland FR, Claggett BL, Vaduganathan M, Desai A, Jhund P, Vardeny O, Fang JC, de Boer RA, Docherty KF, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Saraiva JFK, McGrath MM, Shah SJ, Verma S, Langkilde AM, Petersson M, McMurray JJV, Solomon SD. Decline in Estimated Glomerular Filtration Rate After Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Secondary Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2024 Feb 1;9(2):144-152. doi: 10.1001/jamacardio.2023.4664.
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.
Ostrominski JW, Vaduganathan M, Selvaraj S, Claggett BL, Miao ZM, Desai AS, Jhund PS, Kosiborod MN, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Petersson M, Maria Langkilde A, McMurray JJV, Solomon SD. Dapagliflozin and Apparent Treatment-Resistant Hypertension in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: The DELIVER Trial. Circulation. 2023 Dec 12;148(24):1945-1957. doi: 10.1161/CIRCULATIONAHA.123.065254. Epub 2023 Oct 13.
Bhatt AS, Kosiborod MN, Claggett BL, Miao ZM, Vaduganathan M, Lam CSP, Hernandez AF, Martinez FA, Inzucchi SE, Shah SJ, de Boer RA, Jhund PS, Desai AS, Fang JC, Han Y, Comin-Colet J, Drozdz J, Vardeny O, Merkely B, Lindholm D, Peterson M, Langkilde AM, McMurray JJV, Solomon SD. Impact of COVID-19 in patients with heart failure with mildly reduced or preserved ejection fraction enrolled in the DELIVER trial. Eur J Heart Fail. 2023 Dec;25(12):2177-2188. doi: 10.1002/ejhf.3043. Epub 2023 Oct 9.
Peikert A, Bart BA, Vaduganathan M, Claggett BL, Kulac IJ, Kosiborod MN, Desai AS, Jhund PS, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Petersson M, Langkilde AM, McMurray JJV, Solomon SD, Vardeny O. Contemporary Use and Implications of Beta-Blockers in Patients With HFmrEF or HFpEF: The DELIVER Trial. JACC Heart Fail. 2024 Apr;12(4):631-644. doi: 10.1016/j.jchf.2023.09.007. Epub 2023 Sep 27.
Chatur S, Vaduganathan M, Claggett BL, Mc Causland FR, Desai AS, Jhund PS, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez FA, Shah SJ, Sabatine MS, Kober L, Ponikowski P, Merkely B, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Dapagliflozin in Patients With Heart Failure and Deterioration in Renal Function. J Am Coll Cardiol. 2023 Nov 7;82(19):1854-1863. doi: 10.1016/j.jacc.2023.08.026. Epub 2023 Aug 25.
Butt JH, Lu H, Kondo T, Bachus E, de Boer RA, Inzucchi SE, Jhund PS, Kosiborod MN, Lam CSP, Martinez FA, Vaduganathan M, Solomon SD, McMurray JJV. Heart failure, chronic obstructive pulmonary disease and efficacy and safety of dapagliflozin in heart failure with mildly reduced or preserved ejection fraction: Insights from DELIVER. Eur J Heart Fail. 2023 Nov;25(11):2078-2090. doi: 10.1002/ejhf.3000. Epub 2023 Sep 1.
Chatur S, Vaduganathan M, Claggett BL, Cunningham JW, Docherty KF, 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. Outpatient Worsening Among Patients With Mildly Reduced and Preserved Ejection Fraction Heart Failure in the DELIVER Trial. Circulation. 2023 Nov 28;148(22):1735-1745. doi: 10.1161/CIRCULATIONAHA.123.066506. Epub 2023 Aug 26.
Peikert A, Goyal P, Vaduganathan M, Claggett BL, Kulac IJ, Miao ZM, Vardeny O, Kosiborod MN, Desai AS, Jhund PS, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction According to Polypharmacy Status. JACC Heart Fail. 2023 Oct;11(10):1380-1393. doi: 10.1016/j.jchf.2023.05.014. Epub 2023 May 21.
Ostrominski JW, Thierer J, Claggett BL, Miao ZM, Desai AS, Jhund PS, Kosiborod MN, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Petersson M, Langkilde AM, McMurray JJV, Solomon SD, Vaduganathan M. Cardio-Renal-Metabolic Overlap, Outcomes, and Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JACC Heart Fail. 2023 Nov;11(11):1491-1503. doi: 10.1016/j.jchf.2023.05.015. Epub 2023 May 24.
Bhatt AS, Lindholm D, Nilsson A, Zaozerska N, Claggett BL, Vaduganathan M, Kosiborod MN, Lam CSP, Hernandez AF, Martinez FA, Inzucchi SE, Shah SJ, de Boer RA, Desai A, Jhund PS, Langkilde AM, Petersson M, McMurray JJV, Solomon SD. Operational challenges and mitigation measures during the COVID-19 pandemic-Lessons from DELIVER. Am Heart J. 2023 Sep;263:133-140. doi: 10.1016/j.ahj.2023.05.013. Epub 2023 May 21.
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.
Chatur S, Vaduganathan M, Claggett B, Vardeny O, Desai AS, Jhund PS, de Boer RA, Lam CSP, Kosiborod MN, Shah SJ, Martinez F, Inzucchi SE, Hernandez AF, Haddad T, Mitter SS, Miao ZM, Petersson M, Maria Langkilde A, McMurray JJV, Solomon SD. Dapagliflozin and diuretic utilization in heart failure with mildly reduced or preserved ejection fraction: the DELIVER trial. Eur Heart J. 2023 Aug 14;44(31):2930-2943. doi: 10.1093/eurheartj/ehad283.
Chatur S, Cunningham JW, Vaduganathan M, Mc Causland FR, Claggett BL, Desai AS, Miao ZM, 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. Renal and blood pressure effects of dapagliflozin in recently hospitalized patients with heart failure with mildly reduced or preserved ejection fraction: Insights from the DELIVER trial. Eur J Heart Fail. 2023 Jul;25(7):1170-1175. doi: 10.1002/ejhf.2915. Epub 2023 Jun 8.
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.
Peikert A, Chandra A, Kosiborod MN, Claggett BL, Desai AS, Jhund PS, Lam CSP, Inzucchi SE, Martinez FA, de Boer RA, Hernandez AF, Shah SJ, Janssens SP, Belohlavek J, Borleffs CJW, Dobreanu D, Langkilde AM, Bengtsson O, Petersson M, McMurray JJV, Solomon SD, Vaduganathan M. Association of Dapagliflozin vs Placebo With Individual Kansas City Cardiomyopathy Questionnaire Components in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Secondary Analysis of the DELIVER Trial. JAMA Cardiol. 2023 Jul 1;8(7):684-690. doi: 10.1001/jamacardio.2023.1342.
Jhund PS, Claggett BL, Talebi A, Butt JH, Gasparyan SB, Wei LJ, McCaw ZR, Wilderang U, Bengtsson O, Desai AS, Petersson M, Langkilde AM, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez FA, Shah SJ, Vaduganathan M, Solomon SD, McMurray JJV. Effect of Dapagliflozin on Total Heart Failure Events in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the DELIVER Trial. JAMA Cardiol. 2023 Jun 1;8(6):554-563. doi: 10.1001/jamacardio.2023.0711.
Vaduganathan M, Claggett BL, Jhund P, Miao ZM, de Boer RA, Lam CSP, Desai AS, Bengsston O, McMurray JJV, Solomon SD. Dapagliflozin and All-Cause Hospitalizations in Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2023 Mar 14;81(10):1004-1006. doi: 10.1016/j.jacc.2022.12.026. No abstract available.
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.
Kondo T, Jering KS, Borleffs CJW, de Boer RA, Claggett BL, Desai AS, Dobreanu D, Inzucchi SE, Hernandez AF, Janssens SP, Jhund PS, Kosiborod MN, Lam CSP, Langkilde AM, Martinez FA, Petersson M, Vinh PN, Vaduganathan M, Solomon SD, McMurray JJV. Patient Characteristics, Outcomes, and Effects of Dapagliflozin According to the Duration of Heart Failure: A Prespecified Analysis of the DELIVER Trial. Circulation. 2023 Apr 4;147(14):1067-1078. doi: 10.1161/CIRCULATIONAHA.122.062918. Epub 2023 Mar 6.
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.
Selvaraj S, Vaduganathan M, Claggett BL, Miao ZM, Fang JC, Vardeny O, Desai AS, Shah SJ, Lam CSP, Martinez FA, Inzucchi SE, de Boer RA, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Blood Pressure and Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: DELIVER. JACC Heart Fail. 2023 Jan;11(1):76-89. doi: 10.1016/j.jchf.2022.09.002. Epub 2022 Oct 2.
Kosiborod MN, Bhatt AS, Claggett BL, Vaduganathan M, Kulac IJ, Lam CSP, Hernandez AF, Martinez FA, Inzucchi SE, Shah SJ, de Boer RA, Jhund PS, Desai AS, Fang JC, Han Y, Comin-Colet J, Vardeny O, Lindholm D, Wilderang U, Bengtsson O, McMurray JJV, Solomon SD. Effect of Dapagliflozin on Health Status in Patients With Preserved or Mildly Reduced Ejection Fraction. J Am Coll Cardiol. 2023 Feb 7;81(5):460-473. doi: 10.1016/j.jacc.2022.11.006. Epub 2022 Dec 14.
Vardeny O, Fang JC, Desai AS, Jhund PS, Claggett B, Vaduganathan M, de Boer RA, Hernandez AF, Lam CSP, Inzucchi SE, Martinez FA, Kosiborod MN, DeMets D, O'Meara E, Zieroth S, Comin-Colet J, Drozdz J, Chiang CE, Kitakaze M, Petersson M, Lindholm D, Langkilde AM, McMurray JJV, Solomon SD. Dapagliflozin in heart failure with improved ejection fraction: a prespecified analysis of the DELIVER trial. Nat Med. 2022 Dec;28(12):2504-2511. doi: 10.1038/s41591-022-02102-9. Epub 2022 Dec 15.
Inzucchi SE, Claggett BL, Vaduganathan M, Desai AS, Jhund PS, de Boer RA, Hernandez AF, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Verma S, Han Y, Kerr Saraiva JF, Bengtsson O, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Efficacy and safety of dapagliflozin in patients with heart failure with mildly reduced or preserved ejection fraction by baseline glycaemic status (DELIVER): a subgroup analysis from an international, multicentre, double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2022 Dec;10(12):869-881. doi: 10.1016/S2213-8587(22)00308-4. Epub 2022 Nov 10.
Mc Causland FR, Claggett BL, Vaduganathan M, Desai AS, Jhund P, de Boer RA, Docherty K, Fang J, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Saraiva JFK, McGrath MM, Shah SJ, Verma S, Langkilde AM, Petersson M, McMurray JJV, Solomon SD. Dapagliflozin and Kidney Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):56-65. doi: 10.1001/jamacardio.2022.4210.
Vaduganathan M, Claggett BL, Jhund P, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Hegde SM, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Time to Clinical Benefit of Dapagliflozin in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction: A Prespecified Secondary Analysis of the DELIVER Randomized Clinical Trial. JAMA Cardiol. 2022 Dec 1;7(12):1259-1263. doi: 10.1001/jamacardio.2022.3750.
Desai AS, Jhund PS, Claggett BL, Vaduganathan M, Miao ZM, Kondo T, Barkoudah E, Brahimi A, Connolly E, Finn P, Lang NN, Mc Causland FR, McGrath M, Petrie MC, McMurray JJV, Solomon SD. Effect of Dapagliflozin on Cause-Specific Mortality in Patients With Heart Failure Across the Spectrum of Ejection Fraction: A Participant-Level Pooled Analysis of DAPA-HF and DELIVER. JAMA Cardiol. 2022 Dec 1;7(12):1227-1234. doi: 10.1001/jamacardio.2022.3736.
Myhre PL, Vaduganathan M, Claggett BL, Miao ZM, Jhund PS, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Influence of NT-proBNP on Efficacy of Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JACC Heart Fail. 2022 Dec;10(12):902-913. doi: 10.1016/j.jchf.2022.08.007. Epub 2022 Aug 27.
Peters AE, Ogunniyi MO, Hegde SM, Bianco C, Ghafghazi S, Hernandez AF, DeVore AD. A multicenter program for electronic health record screening for patients with heart failure with preserved ejection fraction: Lessons from the DELIVER-EHR initiative. Contemp Clin Trials. 2022 Oct;121:106924. doi: 10.1016/j.cct.2022.106924. Epub 2022 Sep 12.
Cunningham JW, Vaduganathan M, Claggett BL, Kulac IJ, Desai AS, Jhund PS, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, McGrath MM, O'Meara E, Wilderang U, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Dapagliflozin in Patients Recently Hospitalized With Heart Failure and Mildly Reduced or Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Oct 4;80(14):1302-1310. doi: 10.1016/j.jacc.2022.07.021. Epub 2022 Aug 27.
Vaduganathan M, Claggett BL, Jhund P, de Boer RA, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Estimated Long-Term Benefit of Dapagliflozin in Patients With Heart Failure. J Am Coll Cardiol. 2022 Nov 8;80(19):1775-1784. doi: 10.1016/j.jacc.2022.08.745. Epub 2022 Aug 27.
Butt JH, Kondo T, Jhund PS, Comin-Colet J, de Boer RA, Desai AS, Hernandez AF, Inzucchi SE, Janssens SP, Kosiborod MN, Lam CSP, Langkilde AM, Lindholm D, Martinez F, Petersson M, Shah SJ, Thierer J, Vaduganathan M, Verma S, Wilderang U, Claggett BC, Solomon SD, McMurray JJV. Atrial Fibrillation and Dapagliflozin Efficacy in Patients With Preserved or Mildly Reduced Ejection Fraction. J Am Coll Cardiol. 2022 Nov 1;80(18):1705-1717. doi: 10.1016/j.jacc.2022.08.718. Epub 2022 Aug 27.
Peikert A, Martinez FA, Vaduganathan M, Claggett BL, Kulac IJ, Desai AS, Jhund PS, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Shah SJ, Katova T, Merkely B, Vardeny O, Wilderang U, Lindholm D, Petersson M, Langkilde AM, McMurray JJV, Solomon SD. Efficacy and Safety of Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction According to Age: The DELIVER Trial. Circ Heart Fail. 2022 Oct;15(10):e010080. doi: 10.1161/CIRCHEARTFAILURE.122.010080. Epub 2022 Aug 27.
Butt JH, Jhund PS, Belohlavek J, de Boer RA, Chiang CE, Desai AS, Drozdz J, Hernandez AF, Inzucchi SE, Katova T, Kitakaze M, Kosiborod MN, Lam CSP, Maria Langkilde A, Lindholm D, Bachus E, Martinez F, Merkely B, Petersson M, Saraiva JFK, Shah SJ, Vaduganathan M, Vardeny O, Wilderang U, Claggett BL, Solomon SD, McMurray JJV. Efficacy and Safety of Dapagliflozin According to Frailty in Patients With Heart Failure: A Prespecified Analysis of the DELIVER Trial. Circulation. 2022 Oct 18;146(16):1210-1224. doi: 10.1161/CIRCULATIONAHA.122.061754. Epub 2022 Aug 27.
Solomon SD, McMurray JJV, Claggett B, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Desai AS, Jhund PS, Belohlavek J, Chiang CE, Borleffs CJW, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer-Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Saraiva JFK, Tereshchenko SN, Thierer J, Vaduganathan M, Vardeny O, Verma S, Pham VN, Wilderang U, Zaozerska N, Bachus E, Lindholm D, Petersson M, Langkilde AM; DELIVER Trial Committees and Investigators. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2022 Sep 22;387(12):1089-1098. doi: 10.1056/NEJMoa2206286. Epub 2022 Aug 27.
Solomon SD, Vaduganathan M, Claggett BL, de Boer RA, DeMets D, Hernandez AF, Inzucchi SE, Kosiborod MN, Lam CSP, Martinez F, Shah SJ, Belohlavek J, Chiang CE, Willem Borleffs CJ, Comin-Colet J, Dobreanu D, Drozdz J, Fang JC, Alcocer Gamba MA, Al Habeeb W, Han Y, Cabrera Honorio JW, Janssens SP, Katova T, Kitakaze M, Merkely B, O'Meara E, Kerr Saraiva JF, Tereschenko SN, Thierer J, Vardeny O, Verma S, Vinh PN, Wilderang U, Zaozerska N, Lindholm D, Petersson M, McMurray JJV. Baseline Characteristics of Patients With HF With Mildly Reduced and Preserved Ejection Fraction: DELIVER Trial. JACC Heart Fail. 2022 Mar;10(3):184-197. doi: 10.1016/j.jchf.2021.11.006.
Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.
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.
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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Redacted Clinical Study Protocol
Redacted Statistical Analysis Plan
Other Identifiers
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2018-000802-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D169CC00001
Identifier Type: -
Identifier Source: org_study_id
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