Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Heart Failure; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Empagliflozin 10 mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): The subject will receive Empagliflozin 10 mg orally once daily for 26 weeks.; The subject will receive Placebo orally once daily for 26 weeks.
Other intervention name(s): Jardiance; Sugar pill
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biomarker; Heart failure; SGLT-2 inhibitor; Empagliflozin; Randomized controlled trial