Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction
NCT ID: NCT03087773
Last Updated: 2024-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
476 participants
INTERVENTIONAL
2017-05-11
2022-05-17
Brief Summary
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Detailed Description
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Sodium-dependent glucose cotransporter 2 (SGLT-2) is mainly expressed in human kidneys and small intestinal cells. In the proximal tubule of the nephron SGLT-2 is responsible for the reabsorption of approximately 90% of the filtrated glucose. Inhibition of SGLT-2 was shown to increase renal glucose excretion and to lower glucose. Subsequently, a number of SGLT-2 inhibitors were developed and are currently approved for the treatment of type 2 diabetes.
Recently, Zinman et al published the results of the Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patient trial (EMPA REG OUTCOME TRIAL) where the cardiovascular impact of a glucose lowering regimen including Empagliflozin as compared to usual glucose control without an SGLT-2 inhibitor was investigated. The trial demonstrated an unexpected reduction in the primary composite endpoint, comprising cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. The reduction was mainly driven by a 38% relative risk reduction in cardiovascular deaths; moreover they demonstrated an impressive 35% relative risk reduction in the secondary endpoint hospitalization for heart failure. Of note, the beneficial effects observed in the Empagliflozin group seem to occur very rapidly after commencing the treatment, as suggested by the early separation of the Kaplan-Meier curves. However, the mechanisms responsible for this finding remain unclear. Diuretic effects with subsequent impact on hemodynamics or potential cardioprotective effects of glucagon, which levels rise under the treatment with SGLT-2 inhibitors and the resulting rise in ketone bodies or a small increase in hematocrit have been suggested.
The aim of our trial is to investigate whether Empagliflozin treatment commenced within 72-h after acute myocardial infarction has an impact on heart failure in subjects with and without diabetes mellitus type 2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Empagliflozin
The subjects will receive Empagliflozin 10mg.
Empagliflozin 10 mg
The subject will receive Empagliflozin 10 mg orally once daily for 26 weeks.
Placebo Oral Tablet
The subjects will receive placebo.
Placebo Oral Tablet
The subject will receive Placebo orally once daily for 26 weeks.
Interventions
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Empagliflozin 10 mg
The subject will receive Empagliflozin 10 mg orally once daily for 26 weeks.
Placebo Oral Tablet
The subject will receive Placebo orally once daily for 26 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptoms of ischemia
* ECG (electrocardiogram) changes indicative of new ischemia (new ST-T changes or new LBBB)
* Imaging evidence of new regional wall motion abnormality
2. 18 - 80 years of age
3. Informed consent has to be given in written form
4. estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2
5. Blood pressure before first drug dosing: Riva Rocci (RR) systolic \>110 mmHg
6. Blood pressure before first drug dosing: Riva Rocci (RR) diastolic \>70 mmHg
7. ≤72h after myocardial infarction (after the performance of a coronary angiography)
Exclusion Criteria
2. Blood potential hydrogen (pH) \< 7,32
3. Known allergy to SGLT-2 inhibitors
4. Hemodynamic instability as defined by intravenous administration of catecholamine, calcium sensitizers or phosphodiesterase inhibitors
5. \>1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea
6. Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized partner; or medical history of hysterectomy)
7. Acute symptomatic urinary tract infection (UTI) or genital infection
8. Patients currently being treated with any SGLT-2 inhibitor or having received treatment with any SGLT-2 inhibitor within the 4 weeks prior to the screening visit
18 Years
80 Years
ALL
No
Sponsors
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United Arab Emirates University
OTHER
Medical University of Vienna
OTHER
Landeskrankenhaus Feldkirch
OTHER
Paracelsus Medical University
OTHER
Hospital Rudolfstiftung
OTHER
Klinikum Klagenfurt am Wörthersee
OTHER
Barmherzige Brüder Eisenstadt
OTHER
Cardinal Schwarzenberg Hospital
OTHER
Johannes Kepler University of Linz
OTHER
Landesklinikum Sankt Polten
OTHER
Landeskrankenhaus II Graz West
OTHER
Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Harald Sourij, Assoc.-Prof.
Role: STUDY_DIRECTOR
Medical University of Graz
Dirk von Lewinski, Assoc.-Prof.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Barmherzige Brüder Eisenstadt
Eisenstadt, Burgenland, Austria
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Carinthia, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, Austria
Kardinal schwarzenberg Klinikum Schwarzach
Schwarzach im Pongau, Salzburg, Austria
Kepler Universitätsklinikum Linz
Linz, Upper Austria, Austria
VIVIT Institut am akademischen Lehrkrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria
Landeskrankenhaus Graz II Standort West
Graz, , Austria
Medical University of Graz
Graz, , Austria
Uniklinikum Salzburg
Salzburg, , Austria
Krankenanstalt Rudolfstiftung
Vienna, , Austria
Allgemeines Krankenhaus Vienna
Vienna, , Austria
Countries
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References
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Tripolt NJ, Kolesnik E, Pferschy PN, Verheyen N, Ablasser K, Sailer S, Alber H, Berger R, Kaulfersch C, Leitner K, Lichtenauer M, Mader A, Moertl D, Oulhaj A, Reiter C, Rieder T, Saely CH, Siller-Matula J, Weidinger F, Zechner PM, von Lewinski D, Sourij H; EMMY study group. Impact of EMpagliflozin on cardiac function and biomarkers of heart failure in patients with acute MYocardial infarction-The EMMY trial. Am Heart J. 2020 Mar;221:39-47. doi: 10.1016/j.ahj.2019.12.004. Epub 2019 Dec 12.
von Lewinski D, Kolesnik E, Tripolt NJ, Pferschy PN, Benedikt M, Wallner M, Alber H, Berger R, Lichtenauer M, Saely CH, Moertl D, Auersperg P, Reiter C, Rieder T, Siller-Matula JM, Gager GM, Hasun M, Weidinger F, Pieber TR, Zechner PM, Herrmann M, Zirlik A, Holman RR, Oulhaj A, Sourij H. Empagliflozin in acute myocardial infarction: the EMMY trial. Eur Heart J. 2022 Nov 1;43(41):4421-4432. doi: 10.1093/eurheartj/ehac494.
Benedikt M, Mangge H, Aziz F, Curcic P, Pailer S, Herrmann M, Kolesnik E, Tripolt NJ, Pferschy PN, Wallner M, Zirlik A, Sourij H, von Lewinski D. Impact of the SGLT2-inhibitor empagliflozin on inflammatory biomarkers after acute myocardial infarction - a post-hoc analysis of the EMMY trial. Cardiovasc Diabetol. 2023 Jul 5;22(1):166. doi: 10.1186/s12933-023-01904-6.
Aziz F, Tripolt NJ, Pferschy PN, Kolesnik E, Mangge H, Curcic P, Hermann M, Meinitzer A, von Lewinski D, Sourij H; EMMY Investigators. Alterations in trimethylamine-N-oxide in response to Empagliflozin therapy: a secondary analysis of the EMMY trial. Cardiovasc Diabetol. 2023 Jul 20;22(1):184. doi: 10.1186/s12933-023-01920-6.
von Lewinski D, Kolesnik E, Aziz F, Benedikt M, Tripolt NJ, Wallner M, Pferschy PN, von Lewinski F, Schwegel N, Holman RR, Oulhaj A, Moertl D, Siller-Matula J, Sourij H. Timing of SGLT2i initiation after acute myocardial infarction. Cardiovasc Diabetol. 2023 Sep 30;22(1):269. doi: 10.1186/s12933-023-02000-5.
Sourij C, Oulhaj A, Aziz F, Tripolt NJ, Aberer F, Pferschy PN, Postula M, Drexel H, Benedikt M, Kolesnik E, Pieber TR, Bugger H, von Lewinski D, Sourij H. Impact of glycaemic status on the cardiac effects of empagliflozin when initiated immediately after myocardial infarction: A post-hoc analysis of the EMMY trial. Diabetes Obes Metab. 2024 May;26(5):1971-1975. doi: 10.1111/dom.15477. Epub 2024 Jan 29. No abstract available.
Sourij C, Aziz F, Tripolt NJ, Siller-Matula J, Pferschy PN, Kolesnik E, Wallner M, Eyileten C, Postula M, Oulhaj A, Sourij H, von Lewinski D; EMMY study group. Effects of empagliflozin in women and men with acute myocardial infarction: An analysis from the EMMY trial. Hellenic J Cardiol. 2024 Jan-Feb;75:3-8. doi: 10.1016/j.hjc.2023.05.007. Epub 2023 May 24.
Schwegel N, Strohhofer C, Kolesnik E, Oltean S, Huttmair A, Pipp C, Benedikt M, Verheyen N, Gollmer J, Ablasser K, Wallner M, Santner V, Tripolt N, Pferschy P, Zechner P, Alber H, Siller-Matula JM, Kopp K, Zirlik A, Aziz F, Sourij H, von Lewinski D. Impact of empagliflozin on cardiac structure and function assessed by echocardiography after myocardial infarction: a post-hoc sub-analysis of the emmy trial. Clin Res Cardiol. 2025 May;114(5):629-639. doi: 10.1007/s00392-024-02523-1. Epub 2024 Sep 16.
Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HS-2017-01
Identifier Type: -
Identifier Source: org_study_id
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