Περίληψη:
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. © 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
Συγγραφείς:
Anker, S.D.
Butler, J.
Filippatos, G.
Shahzeb Khan, M.
Ferreira, J.P.
Bocchi, E.
Böhm, M.
Brunner-La Rocca, H.P.
Choi, D.-J.
Chopra, V.
Chuquiure, E.
Giannetti, N.
Gomez-Mesa, J.E.
Janssens, S.
Januzzi, J.L.
Gonzalez-Juanatey, J.R.
Merkely, B.
Nicholls, S.J.
Perrone, S.V.
Piña, I.L.
Ponikowski, P.
Senni, M.
Seronde, M.-F.
Sim, D.
Spinar, J.
Squire, I.
Taddei, S.
Tsutsui, H.
Verma, S.
Vinereanu, D.
Zhang, J.
Jamal, W.
Schnaidt, S.
Schnee, J.M.
Brueckmann, M.
Pocock, S.J.
Zannad, F.
Packer, M.
EMPEROR-Preserved Trial Committees
Investigators
Λέξεις-κλειδιά:
acetylsalicylic acid; aldosterone antagonist; amino terminal pro brain natriuretic peptide; angiotensin receptor antagonist; anticoagulant agent; antithrombocytic agent; beta adrenergic receptor blocking agent; calcium channel blocking agent; candesartan; cardiac glycoside; digoxin; dipeptidyl carboxypeptidase inhibitor; diuretic agent; empagliflozin; enkephalinase inhibitor; hydroxymethylglutaryl coenzyme A reductase inhibitor; irbesartan; mineralocorticoid antagonist; nitric acid derivative; perindopril; placebo; sacubitril plus valsartan; sodium glucose cotransporter 2 inhibitor; thiazide diuretic agent; benzhydryl derivative; biological marker; brain natriuretic peptide; cardiovascular agent; empagliflozin; glucoside; peptide fragment; pro-brain natriuretic peptide (1-76), adult; aged; Article; atrial fibrillation; cancer patient; cardiac patient; chronic kidney failure; cohort analysis; comorbidity; controlled study; diabetes mellitus; disease burden; double blind procedure; drug effect; drug screening; Europe; female; heart failure; heart failure with preserved ejection fraction; heart failure with reduced ejection fraction; heart left ventricle ejection fraction; hospitalization; human; major clinical study; male; medical history; non insulin dependent diabetes mellitus; North America; parallel design; phase 3 clinical trial; randomized controlled trial; South and Central America; symptom; blood; clinical trial; heart failure; heart stroke volume; middle aged; multicenter study; non insulin dependent diabetes mellitus; pathophysiology; very elderly, Aged; Aged, 80 and over; Benzhydryl Compounds; Biomarkers; Cardiovascular Agents; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glucosides; Heart Failure; Humans; Male; Middle Aged; Natriuretic Peptide, Brain; Peptide Fragments; Sodium-Glucose Transporter 2 Inhibitors; Stroke Volume
