Baseline characteristics of patients with heart failure with preserved ejection fraction in the EMPEROR-Preserved trial

被引:116
作者
Anker, Stefan D. [1 ,2 ,3 ]
Butler, Javed [4 ]
Filippatos, Gerasimos [5 ]
Shahzeb Khan, Muhammad [4 ]
Pedro Ferreira, Joao [6 ]
Bocchi, Edimar [7 ]
Bohm, Michael [8 ,9 ]
Pieter Brunner-La Rocca, Hans [10 ]
Choi, Dong-Ju [11 ]
Chopra, Vijay [12 ]
Chuquiure, Eduardo [13 ]
Giannetti, Nadia [14 ]
Esteban Gomez-Mesa, Juan [15 ]
Janssens, Stefan [16 ]
Januzzi, James L. [17 ]
Gonzalez-Juanatey, Jose R. [18 ]
Merkely, Bela [19 ]
Nicholls, Stephen J. [20 ]
Perrone, Sergio, V [21 ]
Pina, Ileana L. [22 ]
Ponikowski, Piotr [23 ]
Senni, Michele [24 ]
Seronde, Marie-France [25 ]
Sim, David [26 ]
Spinar, Jindrich [27 ]
Squire, Iain [28 ]
Taddei, Stefano [29 ]
Tsutsui, Hiroyuki [30 ]
Verma, Subodh [31 ]
Vinereanu, Dragos [32 ]
Zhang, Jian [33 ]
Jamal, Waheed [34 ]
Schnaidt, Sven [35 ]
Schnee, Janet M. [36 ]
Brueckmann, Martina [34 ,37 ]
Pocock, Stuart J. [38 ]
Zannad, Faiez [6 ]
Packer, Milton [39 ,40 ]
机构
[1] Berlin Inst Hlth Ctr Regenerat Therapies BCRT, Dept Cardiol CVK, Berlin, Germany
[2] German Ctr Cardiovasc Res DZHK, Partner Site Berlin, Berlin, Germany
[3] Charite Univ Med Berlin, Berlin, Germany
[4] Univ Mississippi, Sch Med, Jackson, MI USA
[5] Natl & Kapodistrian Univ Athens, Sch Med, Athens, Greece
[6] Univ Lorraine, Inserm INI CRCT, Nancy, France
[7] Univ Sao Paulo, Med Sch, Sao Paulo, Brazil
[8] Univ Saarland, Univ Klinikum Saarlandes, Homberg, Germany
[9] Univ Saarland, Med Fak, Homberg, Germany
[10] Maastricht Univ Med Ctr, Maastricht, Netherlands
[11] Seoul Natl Univ, Bundang Hosp, Seoul, South Korea
[12] Medanta Medicity Max Superspecial Hosp, New Delhi, India
[13] Inst Nacl Cardiol Ignacio Chavez, Ciudad De Mexico, Mexico
[14] Ctr Univ Sante McGill, Montreal, PQ, Canada
[15] Fdn Valle del Lili, Cali, Colombia
[16] Univ Hosp Leuven, Leuven, Belgium
[17] Harvard Med Sch, Massachusetts Gen Hosp, Boston, MA 02115 USA
[18] Complejo Hosp Univ Santiago, CIBERCV, La Coruna, Spain
[19] Semmelweis Univ, Budapest, Hungary
[20] Monash Univ, Victorian Heart Inst, Clayton, Vic, Australia
[21] FLENI Inst, Dept Cardiol, Buenos Aires, DF, Argentina
[22] Wayne State Univ, Detroit, MI USA
[23] Wroclaw Med Univ, Wroclaw, Poland
[24] ASST Papa Giovanni XXIII, Bergamo, Italy
[25] Ctr Hosp Reg & Univ Besancon, Besancon, France
[26] Natl Heart Ctr, Singapore, Singapore
[27] Masaryk Univ Hosp, Univ Hosp, Brno, Czech Republic
[28] Glenfield Hosp, NIHR Cardiovasc Biomed Res Ctr, Leicester, Leics, England
[29] Univ Pisa, Dept Clin & Expt Med, Pisa, Italy
[30] Kyushu Univ, Fukuoka, Japan
[31] Univ Toronto, St Michaels Hosp, Toronto, ON, Canada
[32] Univ Med & Pharm Carol Davila, Univ & Emergency Hosp, Bucharest, Romania
[33] Chinese Acad Med Sci, Fuwai Hosp, Beijing, Peoples R China
[34] Boehringer Ingelheim Int GmbH, Ingelheim, Germany
[35] Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany
[36] Boehringer Ingelheim Pharma Inc, Ridgefield, CT USA
[37] Heidelberg Univ, Fac Med Mannheim, Mannheim, Germany
[38] London Sch Hyg & Trop Med, Dept Med Stat, London, England
[39] Baylor Univ, Med Ctr, Dallas, TX USA
[40] Imperial Coll, London, England
关键词
Heart failure with preserved ejection fraction; Sodium– glucose co‐ transporter; 2; inhibitors; Empagliflozin; SPIRONOLACTONE; OUTCOMES;
D O I
10.1002/ejhf.2064
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:2383 / 2392
页数:10
相关论文
共 23 条
[1]   Evaluation of the effects of sodium-glucose co-transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-Preserved Trial [J].
Anker, Stefan D. ;
Butler, Javed ;
Filippatos, Gerasimos S. ;
Jamal, Waheed ;
Salsali, Afshin ;
Schnee, Janet ;
Kimura, Karen ;
Zeller, Cordula ;
George, Jyothis ;
Brueckmann, Martina ;
Zannad, Faiez ;
Packer, Milton ;
Packer, Milton ;
Anker, Stefan D. ;
Butler, Javed ;
Filippatos, Gerasimos S. ;
Zannad, Faiez ;
George, Jyothis ;
Brueckmann, Martina .
EUROPEAN JOURNAL OF HEART FAILURE, 2019, 21 (10) :1279-1287
[2]   Use of sodium-glucose co-transporter-2 inhibitors in patients with and without type 2 diabetes: implications for incident and prevalent heart failure [J].
Butler, Javed ;
Handelsman, Yehuda ;
Bakris, George ;
Verma, Subodh .
EUROPEAN JOURNAL OF HEART FAILURE, 2020, 22 (04) :604-617
[3]   The perindopril in elderly people with chronic heart failure (PEP-CHF) study [J].
Cleland, John G. F. ;
Tendera, Michal ;
Adamus, Jerzy ;
Freemantle, Nick ;
Polonski, Lech ;
Taylor, Jacqueline .
EUROPEAN HEART JOURNAL, 2006, 27 (19) :2338-2345
[4]   Heart failure with preserved ejection fraction: uncertainties and dilemmas [J].
Ferrari, Roberto ;
Boehm, Michael ;
Cleland, John G. F. ;
Paulus, Walter J. S. ;
Pieske, Burkert ;
Rapezzi, Claudio ;
Tavazzi, Luigi .
EUROPEAN JOURNAL OF HEART FAILURE, 2015, 17 (07) :665-671
[5]   Practical Considerations for the Use of Sodium-Glucose Co-Transporter 2 Inhibitors in Heart Failure [J].
Honigberg, Michael C. ;
Vardeny, Orly ;
Vaduganathan, Muthiah .
CIRCULATION-HEART FAILURE, 2020, 13 (02)
[6]  
James SL, 2018, LANCET, V392, P1789, DOI [10.1016/s0140-6736(18)32335-3, 10.1016/S0140-6736(18)32335-3]
[7]   Characterization of health-related quality of life in heart failure patients with preserved versus low ejection fraction in CHARM [J].
Lewis, Eldrin F. ;
Lamas, Gervasio A. ;
O' Meara, Eileen ;
Granger, Christopher B. ;
Dunlap, Mark E. ;
McKelvie, Robert S. ;
Probstfield, Jeffrey L. ;
Young, James B. ;
Michelson, Eric L. ;
Halling, Katarina ;
Carlsson, Jonas ;
Ofsson, Bertil ;
McMurray, John J. V. ;
Yusuf, Salim ;
Swedberg, Karl ;
Pfeffer, Marc A. .
EUROPEAN JOURNAL OF HEART FAILURE, 2007, 9 (01) :83-91
[8]   Irbesartan in Patients with Heart Failure and Preserved Ejection Fraction. [J].
Massie, Barry M. ;
Carson, Peter E. ;
McMurray, John J. ;
Komajda, Michel ;
McKelvie, Robert ;
Zile, Michael R. ;
Anderson, Susan ;
Donovan, Mark ;
Iverson, Erik ;
Staiger, Christoph ;
Ptaszynska, Agata .
NEW ENGLAND JOURNAL OF MEDICINE, 2008, 359 (23) :2456-2467
[9]   Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction [J].
McMurray, J. J. V. ;
Solomon, S. D. ;
Inzucchi, S. E. ;
Kober, L. ;
Kosiborod, M. N. ;
Martinez, F. A. ;
Ponikowski, P. ;
Sabatine, M. S. ;
Anand, I. S. ;
Belohlavek, J. ;
Bohm, M. ;
Chiang, C. -E. ;
Chopra, V. K. ;
de Boer, R. A. ;
Desai, A. S. ;
Diez, M. ;
Drozdz, J. ;
Dukat, A. ;
Ge, J. ;
Howlett, J. G. ;
Katova, T. ;
Kitakaze, M. ;
Ljungman, C. E. A. ;
Merkely, B. ;
Nicolau, J. C. ;
O'Meara, E. ;
Petrie, M. C. ;
Vinh, P. N. ;
Schou, M. ;
Tereshchenko, S. ;
Verma, S. ;
Held, C. ;
DeMets, D. L. ;
Docherty, K. F. ;
Jhund, P. S. ;
Bengtsson, O. ;
Sjostrand, M. ;
Langkilde, A. -M. .
NEW ENGLAND JOURNAL OF MEDICINE, 2019, 381 (21) :1995-2008
[10]   Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes [J].
Neal, Bruce ;
Perkovic, Vlado ;
Mahaffey, Kenneth W. ;
de Zeeuw, Dick ;
Fulcher, Greg ;
Erondu, Ngozi ;
Shaw, Wayne ;
Law, Gordon ;
Desai, Mehul ;
Matthews, David R. .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (07) :644-657