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Trial record 32 of 187 for:    BI10773

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

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ClinicalTrials.gov Identifier: NCT03087773
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
United Arab Emirates University
Medical University of Vienna
Landeskrankenhaus Feldkirch
Krankenhaus der Barmherzigen Brüder Linz
Paracelsus Medical University
Hospital Rudolfstiftung
Klinikum Klagenfurt am Wörthersee
Information provided by (Responsible Party):
Medical University of Graz

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Empagliflozin 10 mg Drug: Placebo Oral Tablet Phase 3

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 EMPA-REG-OUTCOME (Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patient) 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : November 2, 2019
Estimated Study Completion Date : April 2, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Empagliflozin
The subjects will receive Empagliflozin 10mg.
Drug: Empagliflozin 10 mg
The subject will receive Empagliflozin 10 mg orally once daily for 26 weeks.
Other Name: Jardiance

Placebo Comparator: Placebo Oral Tablet
The subjects will receive placebo.
Drug: Placebo Oral Tablet
The subject will receive Placebo orally once daily for 26 weeks.
Other Name: Sugar pill




Primary Outcome Measures :
  1. change of nt-proBNP levels [ Time Frame: 26 weeks ]
    Difference in the change of nt-proBNP levels between treatment groups from randomization to week 26


Secondary Outcome Measures :
  1. changes of ejection fraction [ Time Frame: 26 weeks ]
    Difference in the change of ejection fraction between treatment groups from randomization to week 26

  2. changes of ejection fraction [ Time Frame: 6 weeks ]
    Difference in the change of ejection fraction between treatment groups from randomization to week 6

  3. changes of left ventricular diastolic function [ Time Frame: 26 weeks ]
    Difference in the change of left ventricular diastolic function from randomization to week 26

  4. changes of left ventricular diastolic function [ Time Frame: 6 weeks ]
    Difference in the change of left ventricular diastolic function from randomization to week 6

  5. changes of nt-proBNP levels [ Time Frame: 6 weeks ]
    Difference in the change of nt-proBNP levels between treatment groups from randomization to week 6

  6. changes of HbA1c [ Time Frame: 26 weeks ]
    Difference in the change of HbA1c between treatment groups from randomization to week 26 (in subjects with known diabetes mellitus Type 2)

  7. changes of body weight [ Time Frame: 6 weeks ]
    Difference in the change of body weight between treatment groups from randomization to week 6

  8. changes of body weight [ Time Frame: 26 weeks ]
    Difference in the change of body weight between treatment groups from randomization to week 26

  9. changes of blood beta-hydroxybutyrate levels [ Time Frame: 6 weeks ]
    Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 6

  10. changes of blood beta-hydroxybutyrate levels [ Time Frame: 26 weeks ]
    Difference in the change of blood beta-hydroxybutyrate levels between the treatment groups from randomization to week 26

  11. number of hospital re-admissions due to heart failure [ Time Frame: 30 weeks ]
    Difference in the number of hospital re-admissions due to heart failure between the treatment groups

  12. number of hospital re-admissions for any cause [ Time Frame: 30 weeks ]
    Difference in the number of hospital re-admissions for any cause between the treatment groups

  13. duration of hospital stay [ Time Frame: 30 weeks ]
    Difference in the duration of hospital stay between the treatment groups after initiation of the study treatment



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Myocardial infarction with evidence of significant myocardial necrosis defined as a rise in creatinine kinase >1000 U/l and a troponin T-level (or troponin I-level) >10x ULN (upper limit of normal). 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
  2. 18 - 75 years of age
  3. Informed consent has to be given in written form
  4. eGFR (glomerular filtration rate) > 45 ml/min/1.73m2
  5. Blood pressure before first drug dosing >110/70 mmHg
  6. ≤72h after myocardial infarction

Exclusion Criteria:

  1. Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
  2. Blood pH (potential hydrogen) < 7,32
  3. Known allergy to SGLT-2 inhibitors
  4. Haemodynamic instability as defined by intravenous administration of catecholamine, calcium sensitizers or phosphodiesterase inhibitors
  5. >1 episode of severe hypoglycaemia within the last 6 months and treatment with insulin or sulfonylurea
  6. Females of child bearing potential without adequate contraceptive methods (i.e. sterilisation, intrauterine device, vasectomised partner; or medical history of hysterectomy)
  7. Acute symptomatic urinary tract infection (UTI) or genital infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087773


Contacts
Contact: Harald Sourij, Assoc.-Prof. +43 316 385 78038 ext 81310 ha.sourij@medunigraz.at
Contact: Norbert J Tripolt, PhD +43 316 385 ext 78038 norbert.tripolt@medunigraz.at

Locations
Austria
Klinikum Klagenfurt am Wörthersee Recruiting
Klagenfurt, Kärnten, Austria, 9020
Contact: Carl Kaulfersch, MD         
Barmherzige Brüder Konventhospital Linz Not yet recruiting
Linz, Oberösterreich, Austria, 4021
Contact: Martin Clodi, Univ.-Prof.         
VIVIT Institut am akademischen Lehrkrankenhaus Feldkirch Recruiting
Feldkirch, Vorarlberg, Austria, 6800
Contact: Christoph Säly, Univ.-Prof.         
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Dirk von Lewinski, Assoc.-Prof.       dirk.von-lewinski@medunigraz.at   
Uniklinikum Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Uta Hoppe, Univ.-Prof.         
Krankenanstalt Rudolfstiftung Not yet recruiting
Vienna, Austria, 1030
Contact: Franz Weidinger, Univ.-Prof.         
AKH Vienna Recruiting
Vienna, Austria, 1090
Contact: Jolanta Siller-Matula, Assoc.-Prof.         
Sponsors and Collaborators
Medical University of Graz
United Arab Emirates University
Medical University of Vienna
Landeskrankenhaus Feldkirch
Krankenhaus der Barmherzigen Brüder Linz
Paracelsus Medical University
Hospital Rudolfstiftung
Klinikum Klagenfurt am Wörthersee
Investigators
Study Director: Harald Sourij, Assoc.-Prof. Medical University of Graz
Principal Investigator: Dirk von Lewinski, Assoc.-Prof. Medical University of Graz

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03087773     History of Changes
Other Study ID Numbers: HS-2017-01
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Empagliflozin
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs