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Acute Myocardial InfarctionPhase 3EMMYNCT03087773

Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction

A Phase 3 study testing Empagliflozin 10 mg in people with Acute Myocardial Infarction, run by Medical University of Graz at 11 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is planned to investigate the impact of Empagliflozin on biomarkers of heart failure in patients with myocardial infarction with and without type 2 diabetes mellitus within 6 months after the event. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Empagliflozin 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
476 participants
Where
11 sitesAustria
Study dates
11 May 2017to 17 May 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Myocardial infarction with evidence of significant myocardial necrosis defined as a rise in creatinine kinase >800 U/l and a troponin T-level (or troponin I-level) >10x upper limit of normal (ULN). In addition at least 1 of the following criteria must be the met:
  • 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
  • 18 - 80 years of age
  • Informed consent has to be given in written form
Show all 10Show fewer
  • estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73m2
  • Blood pressure before first drug dosing: Riva Rocci (RR) systolic >110 mmHg
  • Blood pressure before first drug dosing: Riva Rocci (RR) diastolic >70 mmHg
  • ≤72h after myocardial infarction (after the performance of a coronary angiography)

Who cannot join

  • Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
  • Blood potential hydrogen (pH) < 7,32
  • Known allergy to SGLT-2 inhibitors
  • Hemodynamic instability as defined by intravenous administration of catecholamine, calcium sensitizers or phosphodiesterase inhibitors
  • >1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea
  • Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized partner; or medical history of hysterectomy)
  • Acute symptomatic urinary tract infection (UTI) or genital infection
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Austria11 sites

  • Barmherzige Brüder Eisenstadt

    Eisenstadt, Burgenland, 7000

  • VIVIT Institut am akademischen Lehrkrankenhaus Feldkirch

    Feldkirch, Vorarlberg, 6800

  • Landeskrankenhaus Graz II Standort West

    Graz, 8020

  • Medical University of Graz

    Graz, 8036

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Carinthia, 9020

  • Kepler Universitätsklinikum Linz

    Linz, Upper Austria, 4021

  • Uniklinikum Salzburg

    Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

  • Kardinal schwarzenberg Klinikum Schwarzach

    Schwarzach im Pongau, State of Salzburg, 5620

  • Krankenanstalt Rudolfstiftung

    Vienna, 1030

  • Allgemeines Krankenhaus Vienna

    Vienna, 1090

Other trials in Austria

About this study

This study is planned to investigate the impact of Empagliflozin on biomarkers of heart failure in patients with myocardial infarction with and without type 2 diabetes mellitus within 6 months after the event.

Read the detailed description

Type 2 diabetes mellitus (T2DM) is associated with an about two to three-fold increased risk for cardiovascular events as compared to subjects without diabetes.

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.

Being tested
Empagliflozin 10 mg, Placebo Oral Tablet
Keywords
Biomarker, Heart failure, SGLT-2 inhibitor, Empagliflozin, Randomized controlled trial
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10 mgDrug

    Also called Jardiance

    The subject will receive Empagliflozin 10 mg orally once daily for 26 weeks.

  • Placebo Oral TabletDrug

    Also called Sugar pill

    The subject will receive Placebo orally once daily for 26 weeks.

Study groups in NCT03087773
Study groupRoleWhat they receive
EmpagliflozinActive comparatorThe subjects will receive Empagliflozin 10mg.
Receives: Drug: Empagliflozin 10 mg
Placebo Oral TabletPlacebo comparatorThe subjects will receive placebo.
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of Nt-proBNP (N-terminales Pro Brain Natriuretic Peptide) Levels

    Difference in the change of nt-proBNP (N terminales pro brain natriuretic peptide) levels between treatment groups from randomization to week 26

    Measured: 26 weeks

Secondary outcomes (5)

  1. Changes in Ejection Fraction

    Difference in the change of ejection fraction between treatment groups from randomization to week 26 Ejection fraction was measured by ultrasound.

    Measured: 26 weeks

  2. Changes in Left Ventricular End-diastolic Volume

    Difference in the change of left ventricular end-diastolic volume from randomization to week 26 (measured by ultrasound)

    Measured: 26 weeks

  3. Duration of Hospital Stay

    Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment.

    This outcome measure includes all days of an inpatient stay in a hospital after the initial discharge.

    Measured: 30 weeks

  4. Changes in E/è Ratio From Baseline to Week 26

    E/E' ratio is a measure of left ventricular filling pressure. The E/e' ratio is a parameter for diastolic function assessment that is frequently used for Heart failure with preserved ejection fraction evaluation.

    To derive the E/e´ ratio one must divide the maximum velocity of the E-wave of mitral valve inflow by the maximal velocity of E. In normal individuals the E/e´ ratio is <8. In the presence of diastolic dysfunction / impaired relaxation, e´ will be rather low. In contrast, the E-wave increases with elevated filling pressures. Thus the E/e´ ratio will increase in the presence of diastolic dysfunction. An E/e´ratio >14 is highly suggestive of elevated filling pressures.

    Measured: From Baseline to Week 26

  5. Changes in Left Ventricular End-systolic Volume (LVESV) From Baselin to Week 26

    End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.

    Left ventricular end-systolic volume (LVESV) was measured at baseline and after 26 weeks by echocardiography.

    Measured: Baseline to Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2017
  2. Study start11 May 2017
  3. Primary completion3 May 2022
  4. Study completion17 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
476 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03087773
Sponsor's protocol ID
HS-2017-01
Acronym
EMMY
Status last verified
Aug 2024
First submitted
17 Mar 2017
Last updated
22 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31901799

  • 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.

    PubMed 36036746

  • 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.

    PubMed 37407956

  • 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.

    PubMed 37475009

  • 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.

    PubMed 37777743

  • 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.

    PubMed 38287198

  • 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.

    PubMed 37236318

  • 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.

    PubMed 39297940

  • 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.

    PubMed 34693515

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Empagliflozin 10 mg in people with Acute Myocardial Infarction, run by Medical University of Graz at 11 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Nt-proBNP (N-terminales Pro Brain Natriuretic Peptide) Levels (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03087773, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

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