Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction—The EMMY trial
Sodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocard...
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| Veröffentlicht in: | The American heart journal 2020-03, Vol.221, p.39-47 |
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| creator | Tripolt, Norbert J Kolesnik, Ewald Pferschy, Peter N Verheyen, Nicolas Ablasser, Klemens Sailer, Sandra Alber, Hannes Berger, Rudolf Kaulfersch, Carl Leitner, Katharina Lichtenauer, Michael Mader, Arthur Moertl, Deddo Oulhaj, Abderrahim Reiter, Christian Rieder, Thomas Saely, Christoph H. Siller-Matula, Jolanta Weidinger, Franz Zechner, Peter M von Lewinski, Dirk Sourij, Harald |
| description | Sodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.
Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.
The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI. |
| doi_str_mv | 10.1016/j.ahj.2019.12.004 |
| format | Article |
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Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.
The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2019.12.004</identifier><identifier>PMID: 31901799</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Benzhydryl Compounds - therapeutic use ; Clinical Trials, Phase III as Topic ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - metabolism ; Double-Blind Method ; Echocardiography ; Glucosides - therapeutic use ; Glycated Hemoglobin - metabolism ; Heart Failure - diagnostic imaging ; Heart Failure - metabolism ; Hospitalization ; Humans ; Ketone Bodies - metabolism ; Length of Stay ; Mortality ; Multicenter Studies as Topic ; Myocardial Infarction - complications ; Myocardial Infarction - diagnostic imaging ; Myocardial Infarction - drug therapy ; Myocardial Infarction - metabolism ; Natriuretic Peptide, Brain - metabolism ; Peptide Fragments - metabolism ; Randomized Controlled Trials as Topic ; Sodium-Glucose Transporter 2 Inhibitors - therapeutic use</subject><ispartof>The American heart journal, 2020-03, Vol.221, p.39-47</ispartof><rights>2019 Elsevier Inc.</rights><rights>Copyright © 2019 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c283t-929516aac03fe1f005ddac83aa29a8a9de9a2646ab0421379601c6db8cc7cc353</citedby><cites>FETCH-LOGICAL-c283t-929516aac03fe1f005ddac83aa29a8a9de9a2646ab0421379601c6db8cc7cc353</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ahj.2019.12.004$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64366</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31901799$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tripolt, Norbert J</creatorcontrib><creatorcontrib>Kolesnik, Ewald</creatorcontrib><creatorcontrib>Pferschy, Peter N</creatorcontrib><creatorcontrib>Verheyen, Nicolas</creatorcontrib><creatorcontrib>Ablasser, Klemens</creatorcontrib><creatorcontrib>Sailer, Sandra</creatorcontrib><creatorcontrib>Alber, Hannes</creatorcontrib><creatorcontrib>Berger, Rudolf</creatorcontrib><creatorcontrib>Kaulfersch, Carl</creatorcontrib><creatorcontrib>Leitner, Katharina</creatorcontrib><creatorcontrib>Lichtenauer, Michael</creatorcontrib><creatorcontrib>Mader, Arthur</creatorcontrib><creatorcontrib>Moertl, Deddo</creatorcontrib><creatorcontrib>Oulhaj, Abderrahim</creatorcontrib><creatorcontrib>Reiter, Christian</creatorcontrib><creatorcontrib>Rieder, Thomas</creatorcontrib><creatorcontrib>Saely, Christoph H.</creatorcontrib><creatorcontrib>Siller-Matula, Jolanta</creatorcontrib><creatorcontrib>Weidinger, Franz</creatorcontrib><creatorcontrib>Zechner, Peter M</creatorcontrib><creatorcontrib>von Lewinski, Dirk</creatorcontrib><creatorcontrib>Sourij, Harald</creatorcontrib><creatorcontrib>on behalf of the EMMY study group</creatorcontrib><creatorcontrib>EMMY study group</creatorcontrib><title>Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction—The EMMY trial</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Sodium glucose cotransporter 2 (SGLT2) inhibitors are established antidiabetic drugs with proven cardiovascular benefit. Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.
Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.
The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. 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Although growing evidence suggests beneficial effects on myocardial remodeling, fluid balance and cardiac function, the impact of empagliflozin initiated early after acute myocardial infarction (AMI) has not been investigated yet. Therefore, the impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction (EMMY) trial was designed to investigate the efficacy and safety of empagliflozin in diabetic and non-diabetic patients after severe AMI.
Within a multicenter, randomized, double-blind, placebo-controlled, phase 3b trial we will enroll patients with AMI and characteristics suggestive of severe myocardial necrosis are randomized in a 1:1 ratio to empagliflozin (10 mg once daily) or matching placebo. The primary endpoint is the impact of empagliflozin on changes in NT-proBNP within 6 months after AMI. Secondary endpoints include changes in echocardiographic parameters, levels of ketone body concentrations, HbA1c levels and body weight, respectively. Hospitalization rate due to heart failure or other causes, the duration of hospital stay and all-cause mortality will be assessed as exploratory secondary endpoints.
The EMMY trial will test empagliflozin in patients with AMI regardless of their diabetic status. The EMMY trial may therefore underpin the concept of SGLT2 inhibition to improve cardiac remodeling, pre-and afterload reduction and cardiac metabolism regardless of its antidiabetic effects. Results will provide the rationale for the conduct of a cardiovascular outcome trial to test the effect of empagliflozin in patients with AMI.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>31901799</pmid><doi>10.1016/j.ahj.2019.12.004</doi><tpages>9</tpages></addata></record> |
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| subjects | Benzhydryl Compounds - therapeutic use Clinical Trials, Phase III as Topic Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - metabolism Double-Blind Method Echocardiography Glucosides - therapeutic use Glycated Hemoglobin - metabolism Heart Failure - diagnostic imaging Heart Failure - metabolism Hospitalization Humans Ketone Bodies - metabolism Length of Stay Mortality Multicenter Studies as Topic Myocardial Infarction - complications Myocardial Infarction - diagnostic imaging Myocardial Infarction - drug therapy Myocardial Infarction - metabolism Natriuretic Peptide, Brain - metabolism Peptide Fragments - metabolism Randomized Controlled Trials as Topic Sodium-Glucose Transporter 2 Inhibitors - therapeutic use |
| title | Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction—The EMMY trial |
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