Baseline characteristics of patients with heart failure with preserved ejection fraction in the EMPEROR‐Preserved trial
Creators: name: Anker, Stefan D.
name: Butler, Javed
name: Filippatos, Gerasimos
name: Shahzeb Khan, Muhammad
name: Ferreira, João Pedro
name: Bocchi, Edimar
name: Böhm, Michael
name: Brunner‐La Rocca, Hans Pieter
name: Choi, Dong‐Ju
name: Chopra, Vijay
name: Chuquiure, Eduardo
name: Giannetti, Nadia
name: Gomez‐Mesa, Juan Esteban
name: Janssens, Stefan
name: Januzzi, James L.
name: Gonzalez‐Juanatey, Jose R.
name: Merkely, Bela
name: Nicholls, Stephen J.
name: Perrone, Sergio V.
name: Piña, Ileana L.
name: Ponikowski, Piotr
name: Senni, Michele
name: Seronde, Marie‐France
name: Sim, David
name: Spinar, Jindrich
name: Squire, Iain
name: Taddei, Stefano
name: Tsutsui, Hiroyuki
name: Verma, Subodh
name: Vinereanu, Dragos
name: Zhang, Jian
name: Jamal, Waheed
name: Schnaidt, Sven
name: Schnee, Janet M.
name: Brueckmann, Martina
name: Pocock, Stuart J.
name: Zannad, Faiez
name: Packer, Milton
name: EMPEROR‐Preserved Trial Committees And Investigators
Publisher: name: Charité - Universitätsmedizin Berlin
Year: 2020
Subjects: subject: Heart failure with preserved ejection fraction
subject: Sodium–glucose co-transporter 2 inhibitors
subject: Empagliflozin
subject: 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit

description: 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) &gt;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. &gt;300 pg/mL in patients without and &gt;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.