Stefan D Anker1,2,3, Javed Butler4, Gerasimos Filippatos5, Muhammad Shahzeb Khan4, João Pedro Ferreira6, Edimar Bocchi7, Michael Böhm8, Hans Pieter Brunner-La Rocca9, Dong-Ju Choi10, Vijay Chopra11, Eduardo Chuquiure12, Nadia Giannetti13, Juan Esteban Gomez-Mesa14, Stefan Janssens15, James L Januzzi16, Jose R Gonzalez-Juanatey17, Bela Merkely18, Stephen J Nicholls19, Sergio V Perrone20, Ileana L Piña21, Piotr Ponikowski22, Michele Senni23, Marie-France Seronde24, David Sim25, Jindrich Spinar26, Iain Squire27, Stefano Taddei28, Hiroyuki Tsutsui29, Subodh Verma30, Dragos Vinereanu31, Jian Zhang32, Waheed Jamal33, Sven Schnaidt34, Janet M Schnee35, Martina Brueckmann33,36, Stuart J Pocock37, Faiez Zannad6, Milton Packer38,39. 1. Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies (BCRT), Berlin, Germany. 2. German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Berlin, Germany. 3. Charité Universitätsmedizin Berlin, Berlin, Germany. 4. University of Mississippi School of Medicine, Jackson, MI, USA. 5. National and Kapodistrian University of Athens School of Medicine, Athens, Greece. 6. Université de Lorraine, Inserm INI-CRCT, Nancy, France. 7. São Paulo University Medical School, São Paulo, Brazil. 8. Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homberg, Germany. 9. Maastricht University Medical Center, Maastricht, The Netherlands. 10. Seoul National University Bundang Hospital, Seoul, Republic of Korea. 11. Medanta Medicity to Max Superspeciality Hospital, Saket, New Delhi, India. 12. Instituto Nacional de Cardiologia Ignacio Chavez, Ciudad de Mexico, Mexico. 13. Centre Universitaire de Sante McGill, Montreal, QC, Canada. 14. Fundación Valle del Lili, Cali, Colombia. 15. University Hospitals Leuven, Belgium, Brazil. 16. Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. 17. Complejo Hospitalario Universitario de Santiago, CIBERCV, A Coruña, Spain. 18. Semmelweis University, Budapest, Hungary. 19. Victorian Heart Institute, Monash University, Clayton, VIC, Australia. 20. Department of Cardiology, FLENI Institute, Buenos Aires, Argentina. 21. Wayne State University, Detroit, MI, USA. 22. Wrocław Medical University, Wroclaw, Poland. 23. ASST Papa Giovanni XXIII, Bergamo, Italy. 24. Centre Hospitalier Régional et Universitaire de Besançon, Besançon, France. 25. National Heart Centre, Singapore. 26. University Hospital, Masaryk University Hospital, Brno, Czech Republic. 27. NIHR Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, UK. 28. Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. 29. Kyushu University, Fukuoka City, Japan. 30. St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. 31. University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania. 32. Fuwai Hospital Chinese Academic of Medical Science, Beijing, China. 33. Boehringer Ingelheim International GmbH, Ingelheim, Germany. 34. Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany. 35. Boehringer Ingelheim Pharma, Inc., Ridgefield, CT, USA. 36. Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany. 37. Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK. 38. Baylor University Medical Center, Dallas, TX, USA. 39. Imperial College, London, UK.
Abstract
AIMS: EMPEROR-Preserved is an ongoing trial evaluating the effect of empagliflozin in patients with heart failure with preserved ejection fraction (HFpEF). This report describes the baseline characteristics of the EMPEROR-Preserved cohort and compares them with patients enrolled in prior HFpEF trials. METHODS AND RESULTS: EMPEROR-Preserved is a phase III randomized, international, double-blind, parallel-group, placebo-controlled trial in which 5988 symptomatic HFpEF patients [left ventricular ejection fraction (LVEF) >40%] with and without type 2 diabetes mellitus (T2DM) have been enrolled. Patients were required to have elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations (i.e. >300 pg/mL in patients without and >900 pg/mL in patients with atrial fibrillation) along with evidence of structural changes in the heart or documented history of heart failure hospitalization. Among patients enrolled from various regions (45% Europe, 11% Asia, 25% Latin America, 12% North America), the mean age was 72 ± 9 years, 45% were women. Almost all patients had New York Heart Association class II or III symptoms (99.6%), and 23% had prior heart failure hospitalization within 12 months. Thirty-three percent of the patients had baseline LVEF of 41-50%. The mean LVEF (54 ± 9%) was slightly lower while the median NT-proBNP [974 (499-1731) pg/mL] was higher compared with previous HFpEF trials. Presence of comorbidities such as diabetes (49%) and chronic kidney disease (50%) were common. The majority of the patients were on angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (80%) and beta-blockers (86%), and 37% of patients were on mineralocorticoid receptor antagonists. CONCLUSION: When compared with prior trials in HFpEF, the EMPEROR-Preserved cohort has a somewhat higher burden of comorbidities, lower LVEF, higher median NT-proBNP and greater use of mineralocorticoid receptor antagonists at baseline. Results of the EMPEROR-Preserved trial will be available in 2021.
RCT Entities:
AIMS: EMPEROR-Preserved is an ongoing trial evaluating the effect of empagliflozin in patients with heart failure with preserved ejection fraction (HFpEF). This report describes the baseline characteristics of the EMPEROR-Preserved cohort and compares them with patients enrolled in prior HFpEF trials. METHODS AND RESULTS: EMPEROR-Preserved is a phase III randomized, international, double-blind, parallel-group, placebo-controlled trial in which 5988 symptomatic HFpEF patients [left ventricular ejection fraction (LVEF) >40%] with and without type 2 diabetes mellitus (T2DM) have been enrolled. Patients were required to have elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations (i.e. >300 pg/mL in patients without and >900 pg/mL in patients with atrial fibrillation) along with evidence of structural changes in the heart or documented history of heart failure hospitalization. Among patients enrolled from various regions (45% Europe, 11% Asia, 25% Latin America, 12% North America), the mean age was 72 ± 9 years, 45% were women. Almost all patients had New York Heart Association class II or III symptoms (99.6%), and 23% had prior heart failure hospitalization within 12 months. Thirty-three percent of the patients had baseline LVEF of 41-50%. The mean LVEF (54 ± 9%) was slightly lower while the median NT-proBNP [974 (499-1731) pg/mL] was higher compared with previous HFpEF trials. Presence of comorbidities such as diabetes (49%) and chronic kidney disease (50%) were common. The majority of the patients were on angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (80%) and beta-blockers (86%), and 37% of patients were on mineralocorticoid receptor antagonists. CONCLUSION: When compared with prior trials in HFpEF, the EMPEROR-Preserved cohort has a somewhat higher burden of comorbidities, lower LVEF, higher median NT-proBNP and greater use of mineralocorticoid receptor antagonists at baseline. Results of the EMPEROR-Preserved trial will be available in 2021.
Authors: Stefanie M Werhahn; Christian Becker; Meinhard Mende; Helge Haarmann; Kathleen Nolte; Ulrich Laufs; Samira Zeynalova; Markus Löffler; Nikolaos Dagres; Daniela Husser; Marcus Dörr; Stefan Gross; Stephan B Felix; Astrid Petersmann; Christoph Herrmann-Lingen; Lutz Binder; Martin Scherer; Gerd Hasenfuß; Burkert Pieske; Frank Edelmann; Rolf Wachter Journal: ESC Heart Fail Date: 2021-11-30
Authors: Scott D Solomon; Rudolf A de Boer; David DeMets; Adrian F Hernandez; Silvio E Inzucchi; Mikhail N Kosiborod; Carolyn S P Lam; Felipe Martinez; Sanjiv J Shah; Daniel Lindholm; Ulrica Wilderäng; Fredrik Öhrn; Brian Claggett; Anna Maria Langkilde; Magnus Petersson; John J V McMurray Journal: Eur J Heart Fail Date: 2021-06-09 Impact factor: 15.534