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.

ASST Papa Giovanni XXIII Bergamo Italy

Baylor University Medical Center Dallas TX USA

Boehringer Ingelheim International GmbH Ingelheim Germany

Boehringer Ingelheim Pharma GmbH and Co KG Biberach Germany

Boehringer Ingelheim Pharma Inc Ridgefield CT USA

Centre Hospitalier Régional et Universitaire de Besançon Besançon France

Centre Universitaire de Sante McGill Montreal QC Canada

Charité Universitätsmedizin Berlin Berlin Germany

Complejo Hospitalario Universitario de Santiago CIBERCV A Coruña Spain

Department of Cardiology Berlin Germany

Department of Cardiology FLENI Institute Buenos Aires Argentina

Department of Clinical and Experimental Medicine University of Pisa Pisa Italy

Department of Medical Statistics London School of Hygiene and Tropical Medicine London UK

Faculty of Medicine Mannheim University of Heidelberg Mannheim Germany

Fundación Valle del Lili Cali Colombia

Fuwai Hospital Chinese Academic of Medical Science Beijing China

German Centre for Cardiovascular Research Partner Site Berlin Berlin Germany

Harvard Medical School Massachusetts General Hospital Boston MA USA

Imperial College London UK

Instituto Nacional de Cardiologia Ignacio Chavez Ciudad de Mexico Mexico

Kyushu University Fukuoka City Japan

Maastricht University Medical Center Maastricht The Netherlands

Medanta Medicity to Max Superspeciality Hospital Saket New Delhi India

National and Kapodistrian University of Athens School of Medicine Athens Greece

National Heart Centre Singapore

NIHR Cardiovascular Biomedical Research Centre Glenfield Hospital Leicester UK

São Paulo University Medical School São Paulo Brazil

Semmelweis University Budapest Hungary

Seoul National University Bundang Hospital Seoul Republic of Korea

St Michael's Hospital University of Toronto Toronto ON Canada

Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes Homberg Germany

Université de Lorraine Inserm INI CRCT Nancy France

University Hospital Masaryk University Hospital Brno Czech Republic

University Hospitals Leuven Belgium Brazil

University of Medicine and Pharmacy Carol Davila University and Emergency Hospital Bucharest Romania

University of Mississippi School of Medicine Jackson MI USA

Victorian Heart Institute Monash University Clayton VIC Australia

Wayne State University Detroit MI USA

Wrocław Medical University Wroclaw Poland

Eur J Heart Fail. 2021 May;23(5):841. doi: 10.1002/ejhf.2091. PubMed

Eur J Heart Fail. 2021 Aug;23(8):1256-1259. doi: 10.1002/ejhf.2108. PubMed

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