NCT03087773

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2017

Longer than P75 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 22, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

March 17, 2017

Results QC Date

July 6, 2023

Last Update Submit

August 19, 2024

Conditions

Acute Myocardial Infarction

Keywords

BiomarkerHeart failureSGLT-2 inhibitorEmpagliflozinRandomized controlled trial

Outcome Measures

Primary Outcomes (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

    26 weeks

Secondary Outcomes (5)

  • Changes in Ejection Fraction

    26 weeks

  • Changes in Left Ventricular End-diastolic Volume

    26 weeks

  • Duration of Hospital Stay

    30 weeks

  • Changes in E/è Ratio From Baseline to Week 26

    From Baseline to Week 26

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

    Baseline to Week 26

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

The subjects will receive Empagliflozin 10mg.

Drug: Empagliflozin 10 mg

Placebo Oral Tablet

PLACEBO COMPARATOR

The subjects will receive placebo.

Drug: Placebo Oral Tablet

Interventions

Empagliflozin 10 mgDRUG

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

Also known as: Jardiance
Empagliflozin
Placebo Oral TabletDRUG

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

Also known as: Sugar pill
Placebo Oral Tablet

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age
  • Informed consent has to be given in written form
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Barmherzige Brüder Eisenstadt

Eisenstadt, Burgenland, 7000, Austria

Location

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Carinthia, 9020, Austria

Location

Universitätsklinikum St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

Location

Kardinal schwarzenberg Klinikum Schwarzach

Schwarzach im Pongau, Salzburg, 5620, Austria

Location

Kepler Universitätsklinikum Linz

Linz, Upper Austria, 4021, Austria

Location

VIVIT Institut am akademischen Lehrkrankenhaus Feldkirch

Feldkirch, Vorarlberg, 6800, Austria

Location

Landeskrankenhaus Graz II Standort West

Graz, 8020, Austria

Location

Medical University of Graz

Graz, 8036, Austria

Location

Uniklinikum Salzburg

Salzburg, 5020, Austria

Location

Krankenanstalt Rudolfstiftung

Vienna, 1030, Austria

Location

Allgemeines Krankenhaus Vienna

Vienna, 1090, Austria

Location

Related Publications (9)

  • 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.

    PMID: 31901799BACKGROUND

  • 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.

    PMID: 36036746RESULT

  • 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.

    PMID: 37407956RESULT

  • 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.

    PMID: 37475009RESULT

  • 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.

    PMID: 37777743RESULT

  • 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.

    PMID: 38287198RESULT

  • 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.

    PMID: 37236318RESULT

  • 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.

    PMID: 39297940DERIVED

  • 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.

    PMID: 34693515DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

empagliflozinSugars

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

Title
Univ.-Prof. PD Harald Sourij, MD, MBA
Organization
Medical University of Graz
ha.sourij@medunigraz.at
+43 316 385 81310

Study Officials

  • Harald Sourij, Assoc.-Prof.

    Medical University of Graz

    STUDY DIRECTOR

  • Dirk von Lewinski, Assoc.-Prof.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 23, 2017

Study Start

May 11, 2017

Primary Completion

May 3, 2022

Study Completion

May 17, 2022

Last Updated

August 22, 2024

Results First Posted

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(11)