Scott D Solomon1, Muthiah Vaduganathan2, Brian L Claggett2, Rudolf A de Boer3, David DeMets4, Adrian F Hernandez5, Silvio E Inzucchi6, Mikhail N Kosiborod7, Carolyn S P Lam8, Felipe Martinez9, Sanjiv J Shah10, Jan Belohlavek11, Chern-En Chiang12, C Jan Willem Borleffs13, Josep Comin-Colet14, Dan Dobreanu15, Jaroslaw Drozdz16, James C Fang17, Marco Antonio Alcocer Gamba18, Waleed Al Habeeb19, Yaling Han20, Jose Walter Cabrera Honorio21, Stefan P Janssens22, Tsvetana Katova23, Masafumi Kitakaze24, Bela Merkely25, Eileen O'Meara26, Jose Francisco Kerr Saraiva27, Sergey N Tereschenko28, Jorge Thierer29, Orly Vardeny30, Subodh Verma31, Pham Nguyen Vinh32, Ulrica Wilderäng33, Natalia Zaozerska33, Daniel Lindholm33, Magnus Petersson33, John J V McMurray34. 1. Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: ssolomon@bwh.harvard.edu. 2. Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. 3. University of Groningen, Groningen, the Netherlands. 4. University of Wisconsin, Madison, Wisconsin, USA. 5. Duke University Medical Center, Durham, North Carolina, USA. 6. Yale School of Medicine, New Haven, Connecticut, USA. 7. Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA. 8. University of Groningen, Groningen, the Netherlands; National Heart Centre Singapore & Duke-National University of Singapore, Singapore. 9. University of Cordoba, Cordoba, Argentina. 10. Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. 11. General University Hospital, Charles University, Prague, Czech Republic. 12. General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang Ming Chiao Tung University, Taipei, Taiwan. 13. Haga Teaching Hospital, The Hague, Netherlands. 14. Cardiology Department, Bellvitge University Hospital, Bio-Heart (IDIBELL), University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain. 15. University of Medicine, Pharmacy, Science and Technology "G.E.Palade," Târgu Mureș, Romania. 16. Department Cardiology, Medical University Lodz, Lodz, Poland. 17. University of Utah Medical Center, Salt Lake City, Utah, USA. 18. Centro de Estudios Clínicos de Querétaro (CECLIQ), Querétaro, México. 19. Cardiac Sciences Department, King Saud University, Riyadh, Saudi Arabia. 20. Cardiovascular Research Institute, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China. 21. Clínica Vesalio, San Borja, Peru. 22. Cardiac Intensive Care, Department of Cardiovascular Diseases, University Hospitals Leuven, Leuven, Belgium. 23. Department of Noninvasive Cardiology, National Cardiology Hospital, Sofia, Bulgaria. 24. Kinshukai Hanwa Daini Senboku Hospital, Osaka, JapanHeart and Vascular Center. 25. Semmelweis University, Budapest, Hungary. 26. Institut de Cardiologie de Montréal, Université de Montréal, Montréal, Québec, Canada. 27. Cardiovascular Division, Instituto de Pesquisa Clínica de Campinas, Campinas SP, Brazil. 28. Department of Myocardial Disease and Heart Failure, National Medical Research Center of Cardiology, Moscow, Russia. 29. Jefe de Unidad de Insuficiencia Cardíaca, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (CEMIC), Argentina. 30. Minneapolis VA Center for Care Delivery and Outcomes Research, University of Minnesota, Minneapolis, Minnesota, USA. 31. Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Canada. 32. Cardiovascular Center, Tam Anh hospital, Tan Tao University, Vietnam. 33. Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden. 34. University of Glasgow, Glasgow, Scotland, UK.
Abstract
OBJECTIVES: This report describes the baseline clinical profiles and management of DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial participants and how these compare with those in other contemporary heart failure with preserved ejection fraction trials. BACKGROUND: The DELIVER trial was designed to evaluate the effects of the sodium-glucose cotransporter-2 inhibitor dapagliflozin on cardiovascular death, heart failure (HF) hospitalization, or urgent HF visits in patients with HF with mildly reduced and preserved left ventricular ejection fraction (LVEF). METHODS: Adults with symptomatic HF and LVEF >40%, with or without type 2 diabetes mellitus, elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and evidence of structural heart disease were randomized to dapagliflozin 10 mg once daily or matching placebo. RESULTS: A total of 6,263 patients were randomized (mean age: 72 ± 10 years; 44% women; 45% type 2 diabetes mellitus; 45% with body mass index ≥30 kg/m2; and 57% with history of atrial fibrillation or flutter). Most participants had New York Heart Association functional class II symptoms (75%). Baseline mean LVEF was 54.2 ± 8.8% and median NT-proBNP of 1,399 pg/mL (IQR: 962 to 2,210 pg/mL) for patients in atrial fibrillation/flutter compared with 716 pg/mL (IQR: 469 to 1,281 pg/mL) in those who were not. Patients in both hospitalized and ambulatory settings were enrolled, including 10% enrolled in-hospital or within 30 days of a hospitalization for HF. Eighteen percent of participants had HF with improved LVEF. CONCLUSIONS: DELIVER is the largest and broadest clinical trial of this population to date and enrolled high-risk, well-treated patients with HF with mildly reduced and preserved LVEF. (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [NCT03619213]).
OBJECTIVES: This report describes the baseline clinical profiles and management of DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial participants and how these compare with those in other contemporary heart failure with preserved ejection fraction trials. BACKGROUND: The DELIVER trial was designed to evaluate the effects of the sodium-glucose cotransporter-2 inhibitor dapagliflozin on cardiovascular death, heart failure (HF) hospitalization, or urgent HF visits in patients with HF with mildly reduced and preserved left ventricular ejection fraction (LVEF). METHODS: Adults with symptomatic HF and LVEF >40%, with or without type 2 diabetes mellitus, elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, and evidence of structural heart disease were randomized to dapagliflozin 10 mg once daily or matching placebo. RESULTS: A total of 6,263 patients were randomized (mean age: 72 ± 10 years; 44% women; 45% type 2 diabetes mellitus; 45% with body mass index ≥30 kg/m2; and 57% with history of atrial fibrillation or flutter). Most participants had New York Heart Association functional class II symptoms (75%). Baseline mean LVEF was 54.2 ± 8.8% and median NT-proBNP of 1,399 pg/mL (IQR: 962 to 2,210 pg/mL) for patients in atrial fibrillation/flutter compared with 716 pg/mL (IQR: 469 to 1,281 pg/mL) in those who were not. Patients in both hospitalized and ambulatory settings were enrolled, including 10% enrolled in-hospital or within 30 days of a hospitalization for HF. Eighteen percent of participants had HF with improved LVEF. CONCLUSIONS: DELIVER is the largest and broadest clinical trial of this population to date and enrolled high-risk, well-treated patients with HF with mildly reduced and preserved LVEF. (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [NCT03619213]).
Authors: Saverio Muscoli; Francesco Barillà; Rojin Tajmir; Marco Meloni; David Della Morte; Alfonso Bellia; Nicola Di Daniele; Davide Lauro; Aikaterini Andreadi Journal: Pharmaceutics Date: 2022-08-18 Impact factor: 6.525
Authors: Muthiah Vaduganathan; Jonathan P Piccini; A John Camm; Harry J G M Crijns; Stefan D Anker; Javed Butler; John Stewart; Rogelio Braceras; Alessandro P A Albuquerque; Mattias Wieloch; Stefan H Hohnloser Journal: Eur J Heart Fail Date: 2022-04-10 Impact factor: 17.349
Authors: Carlos Escobar; Beatriz Palacios; Luis Varela; Martín Gutiérrez; Mai Duong; Hungta Chen; Nahila Justo; Javier Cid-Ruzafa; Ignacio Hernández; Phillip R Hunt; Juan F Delgado Journal: BMC Health Serv Res Date: 2022-10-08 Impact factor: 2.908