Jasper Tromp1,2,3, Piotr Ponikowski4, Afshin Salsali5,6, Christiane E Angermann7, Jan Biegus4, Jon Blatchford8, Sean P Collins9, João Pedro Ferreira10, Claudia Grauer8, Mikhail Kosiborod11,12, Michael E Nassif11, Mitchell A Psotka13, Martina Brueckmann8,14, John R Teerlink15, Adriaan A Voors1. 1. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 2. Duke-NUS Medical School, Singapore. 3. National Heart Centre Singapore, Singapore. 4. Department of Heart Diseases, Medical University, Wroclaw, Poland. 5. Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA. 6. Faculty of Medicine, Rutgers University, New Brunswick, NJ, USA. 7. Comprehensive Heart Failure Center, University and University Hospital, Würzburg, University Hospital Würzburg, Würzburg, Germany. 8. Boehringer Ingelheim International GmbH, Ingelheim, Germany. 9. Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA. 10. Université de Lorraine, Inserm, Centre d'Investigation Clinique Plurithématique 1433, CHRU de Nancy, F-CRIN INI-CRCT, Nancy, France. 11. Saint Luke's Mid America Heart Institute and the University of Missouri, Kansas City, MO, USA. 12. The George Institute for Global Health and the University of New South Wales, Sydney, NSW, Australia. 13. Inova Heart and Vascular Institute, Falls Church, VA, USA. 14. Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany. 15. Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Abstract
AIMS: Treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors improves outcomes in patients with chronic heart failure (HF) with reduced ejection fraction. There is limited experience with the in-hospital initiation of SGLT2 inhibitors in patients with acute HF (AHF) with or without diabetes. EMPULSE is designed to assess the clinical benefit and safety of the SGLT2 inhibitor empagliflozin compared with placebo in patients hospitalized with AHF. METHODS: EMPULSE is a randomized, double-blind, parallel-group, placebo-controlled multinational trial comparing the in-hospital initiation of empagliflozin (10 mg once daily) with placebo. Approximately 500 patients admitted for AHF with dyspnoea, signs of fluid overload, and elevated natriuretic peptides will be randomized 1:1 stratified to HF status (de-novo and decompensated chronic HF) to either empagliflozin or placeboat approximately 165 sites across North America, Europe and Asia. Patients will be enrolled regardless of ejection fraction and diabetes status and will be randomized during hospitalization and after stabilization (between 24 h and 5 days after admission), with treatment continued up to 90 days after initiation. The primary outcome is clinical benefit at 90 days, consisting of a composite of all-cause death, HF events, and ≥5 point change from baseline in Kansas City CardiomyopathyQuestionnaire total symptom score (KCCQ-TSS), assessed using a 'win-ratio' approach. Secondary outcomes include assessments of safety, change in KCCQ-TSS from baseline to 90 days and change in natriuretic peptides from baseline to 30 days. CONCLUSION: The EMPULSE trial will evaluate the clinical benefit and safety of empagliflozin in patients hospitalized for AHF.
RCT Entities:
AIMS: Treatment with sodium-glucose co-transporter 2 (SGLT2) inhibitors improves outcomes in patients with chronic heart failure (HF) with reduced ejection fraction. There is limited experience with the in-hospital initiation of SGLT2 inhibitors in patients with acute HF (AHF) with or without diabetes. EMPULSE is designed to assess the clinical benefit and safety of the SGLT2 inhibitor empagliflozin compared with placebo in patients hospitalized with AHF. METHODS: EMPULSE is a randomized, double-blind, parallel-group, placebo-controlled multinational trial comparing the in-hospital initiation of empagliflozin (10 mg once daily) with placebo. Approximately 500 patients admitted for AHF with dyspnoea, signs of fluid overload, and elevated natriuretic peptides will be randomized 1:1 stratified to HF status (de-novo and decompensated chronic HF) to either empagliflozin or placebo at approximately 165 sites across North America, Europe and Asia. Patients will be enrolled regardless of ejection fraction and diabetes status and will be randomized during hospitalization and after stabilization (between 24 h and 5 days after admission), with treatment continued up to 90 days after initiation. The primary outcome is clinical benefit at 90 days, consisting of a composite of all-cause death, HF events, and ≥5 point change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS), assessed using a 'win-ratio' approach. Secondary outcomes include assessments of safety, change in KCCQ-TSS from baseline to 90 days and change in natriuretic peptides from baseline to 30 days. CONCLUSION: The EMPULSE trial will evaluate the clinical benefit and safety of empagliflozin in patients hospitalized for AHF.
Authors: Husam M Salah; Subhi J Al'Aref; Muhammad Shahzeb Khan; Malek Al-Hawwas; Srikanth Vallurupalli; Jawahar L Mehta; J Paul Mounsey; Stephen J Greene; Darren K McGuire; Renato D Lopes; Marat Fudim Journal: Cardiovasc Diabetol Date: 2022-02-05 Impact factor: 9.951
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
Authors: Joost C Beusekamp; Jasper Tromp; Eva M Boorsma; Hiddo J L Heerspink; Kevin Damman; Adriaan A Voors; Peter van der Meer Journal: Eur J Heart Fail Date: 2021-05-11 Impact factor: 15.534