PMID- 33251670 OWN - NLM STAT- MEDLINE DCOM- 20210513 LR - 20210922 IS - 1879-0844 (Electronic) IS - 1388-9842 (Linking) VI - 22 IP - 12 DP - 2020 Dec TI - Baseline characteristics of patients with heart failure with preserved ejection fraction in the EMPEROR-Preserved trial. PG - 2383-2392 LID - 10.1002/ejhf.2064 [doi] AB - 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. CI - (c) 2020 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. FAU - Anker, Stefan D AU - Anker SD AD - Department of Cardiology (CVK), Berlin Institute of Health Center for Regenerative Therapies (BCRT), Berlin, Germany. AD - German Centre for Cardiovascular Research (DZHK) Partner Site Berlin, Berlin, Germany. AD - Charite Universitatsmedizin Berlin, Berlin, Germany. FAU - Butler, Javed AU - Butler J AD - University of Mississippi School of Medicine, Jackson, MI, USA. FAU - Filippatos, Gerasimos AU - Filippatos G AD - National and Kapodistrian University of Athens School of Medicine, Athens, Greece. FAU - Shahzeb Khan, Muhammad AU - Shahzeb Khan M AD - University of Mississippi School of Medicine, Jackson, MI, USA. FAU - Ferreira, Joao Pedro AU - Ferreira JP AD - Universite de Lorraine, Inserm INI-CRCT, Nancy, France. FAU - Bocchi, Edimar AU - Bocchi E AD - Sao Paulo University Medical School, Sao Paulo, Brazil. FAU - Bohm, Michael AU - Bohm M AD - Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes, Homberg, Germany. FAU - Brunner-La Rocca, Hans Pieter AU - Brunner-La Rocca HP AD - Maastricht University Medical Center, Maastricht, The Netherlands. FAU - Choi, Dong-Ju AU - Choi DJ AD - Seoul National University Bundang Hospital, Seoul, Republic of Korea. FAU - Chopra, Vijay AU - Chopra V AD - Medanta Medicity to Max Superspeciality Hospital, Saket, New Delhi, India. FAU - Chuquiure, Eduardo AU - Chuquiure E AD - Instituto Nacional de Cardiologia Ignacio Chavez, Ciudad de Mexico, Mexico. FAU - Giannetti, Nadia AU - Giannetti N AD - Centre Universitaire de Sante McGill, Montreal, QC, Canada. FAU - Gomez-Mesa, Juan Esteban AU - Gomez-Mesa JE AD - Fundacion Valle del Lili, Cali, Colombia. FAU - Janssens, Stefan AU - Janssens S AD - University Hospitals Leuven, Belgium, Brazil. FAU - Januzzi, James L AU - Januzzi JL AD - Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. FAU - Gonzalez-Juanatey, Jose R AU - Gonzalez-Juanatey JR AD - Complejo Hospitalario Universitario de Santiago, CIBERCV, A Coruna, Spain. FAU - Merkely, Bela AU - Merkely B AD - Semmelweis University, Budapest, Hungary. FAU - Nicholls, Stephen J AU - Nicholls SJ AD - Victorian Heart Institute, Monash University, Clayton, VIC, Australia. FAU - Perrone, Sergio V AU - Perrone SV AD - Department of Cardiology, FLENI Institute, Buenos Aires, Argentina. FAU - Pina, Ileana L AU - Pina IL AD - Wayne State University, Detroit, MI, USA. FAU - Ponikowski, Piotr AU - Ponikowski P AD - Wroclaw Medical University, Wroclaw, Poland. FAU - Senni, Michele AU - Senni M AD - ASST Papa Giovanni XXIII, Bergamo, Italy. FAU - Seronde, Marie-France AU - Seronde MF AD - Centre Hospitalier Regional et Universitaire de Besancon, Besancon, France. FAU - Sim, David AU - Sim D AD - National Heart Centre, Singapore. FAU - Spinar, Jindrich AU - Spinar J AD - University Hospital, Masaryk University Hospital, Brno, Czech Republic. FAU - Squire, Iain AU - Squire I AD - NIHR Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, UK. FAU - Taddei, Stefano AU - Taddei S AD - Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. FAU - Tsutsui, Hiroyuki AU - Tsutsui H AD - Kyushu University, Fukuoka City, Japan. FAU - Verma, Subodh AU - Verma S AD - St. Michael's Hospital, University of Toronto, Toronto, ON, Canada. FAU - Vinereanu, Dragos AU - Vinereanu D AD - University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital, Bucharest, Romania. FAU - Zhang, Jian AU - Zhang J AD - Fuwai Hospital Chinese Academic of Medical Science, Beijing, China. FAU - Jamal, Waheed AU - Jamal W AD - Boehringer Ingelheim International GmbH, Ingelheim, Germany. FAU - Schnaidt, Sven AU - Schnaidt S AD - Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany. FAU - Schnee, Janet M AU - Schnee JM AD - Boehringer Ingelheim Pharma, Inc., Ridgefield, CT, USA. FAU - Brueckmann, Martina AU - Brueckmann M AD - Boehringer Ingelheim International GmbH, Ingelheim, Germany. AD - Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany. FAU - Pocock, Stuart J AU - Pocock SJ AD - Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK. FAU - Zannad, Faiez AU - Zannad F AD - Universite de Lorraine, Inserm INI-CRCT, Nancy, France. FAU - Packer, Milton AU - Packer M AD - Baylor University Medical Center, Dallas, TX, USA. AD - Imperial College, London, UK. CN - EMPEROR-Preserved Trial Committees and Investigators LA - eng GR - Boehringer Ingelheim/ GR - Eli Lilly and Company/ PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Eur J Heart Fail JT - European journal of heart failure JID - 100887595 RN - 0 (Benzhydryl Compounds) RN - 0 (Biomarkers) RN - 0 (Cardiovascular Agents) RN - 0 (Glucosides) RN - 0 (Peptide Fragments) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) RN - 0 (pro-brain natriuretic peptide (1-76)) RN - 114471-18-0 (Natriuretic Peptide, Brain) RN - HDC1R2M35U (empagliflozin) SB - IM CIN - Eur J Heart Fail. 2021 May;23(5):841. PMID: 33377246 CIN - Eur J Heart Fail. 2021 Aug;23(8):1256-1259. PMID: 33502794 MH - Aged MH - Aged, 80 and over MH - Benzhydryl Compounds/*therapeutic use MH - Biomarkers/blood MH - Cardiovascular Agents/*therapeutic use MH - *Diabetes Mellitus, Type 2/drug therapy MH - Double-Blind Method MH - Female MH - Glucosides/*therapeutic use MH - *Heart Failure/blood/diagnosis/drug therapy/physiopathology MH - Humans MH - Male MH - Middle Aged MH - Natriuretic Peptide, Brain/blood MH - Peptide Fragments/blood MH - Sodium-Glucose Transporter 2 Inhibitors/therapeutic use MH - Stroke Volume OTO - NOTNLM OT - Empagliflozin OT - Heart failure with preserved ejection fraction OT - Sodium-glucose co-transporter 2 inhibitors EDAT- 2020/12/01 06:00 MHDA- 2021/05/14 06:00 CRDT- 2020/11/30 05:58 PHST- 2020/11/02 00:00 [received] PHST- 2020/11/22 00:00 [revised] PHST- 2020/11/25 00:00 [accepted] PHST- 2020/12/01 06:00 [pubmed] PHST- 2021/05/14 06:00 [medline] PHST- 2020/11/30 05:58 [entrez] AID - 10.1002/ejhf.2064 [doi] PST - ppublish SO - Eur J Heart Fail. 2020 Dec;22(12):2383-2392. doi: 10.1002/ejhf.2064.