Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients
Condition: Myocardial Infarction; Diabetes Mellitus, Type 2; Myocardial Remodeling, Ventricular
MeSH terms: Myocardial Infarction; Diabetes Mellitus, Type 2; Infarction; Ventricular Remodeling
Study type: Interventional

Summary: 
      A prospective, randomized, controlled study will be conducted at Clinical Cardioglogy
      department, Ain Shams University Hospitals, assessing the efficacy and tolerability of SGLT2
      inhibitors (dapagliflozin) addition on the clinical outcome and cardiac remodeling markers of
      post myocardial infarction (MI) diabetic patients
    

Detailed description: 
      All patients presenting to the Clinical Cardiology department, Ain Shams University
      Hospitals, will be assessed for eligibility as follow:

      Inclusion criteria:

        1. Female or male aged >18 and < 75 years

        2. Diabetic post myocardial infarction patients

        3. First anterior STEMI with successful TIMI-3 flow

        4. STEMI within 12 hrs of onset of chest pain

        5. creatine clearance ≥60 mL/min

        6. HbA1c between 6.5% and 12.0%

      Exclusion criteria:

        1. Cardiogenic shock on admission

        2. Multivessel disease on admission

        3. Mechanical complications e.g. mitral regurge on admission

        4. Life threatening arrhythmia on admission

        5. Hemodynamic instability on admission

        6. Diagnosis of Type 1 diabetes mellitus

        7. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis
           at any time

        8. Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab
           tests

        9. Pregnant or breast-feeding patients

       10. Active participation in another clinical study

       11. AST or ALT >3x ULN or Total bilirubin >2.5 x ULN

       12. CrCl < 60 ml/min (based on the Cockroft-Gault equation)

      Eligible patients will be randomly assigned into one of 2 arms:

        1. Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any
           diseases.

        2. Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for
           4 Weeks

        3. Group 3 (Test group) (n= 30): Post-MI patients who will receive standard of care in
           addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks

             -  Dapagliflozin will be administered immediately at time of PCI and daily for 4
                weeks.

             -  Standard of care will given to both arms (group 2 and 3) and includes:

      Dual Antiplatelet Therapy (DAPT), high intensity statin, anticoagulation therapy, ACEI or
      aldosterone antagonist depending on the ejection fraction

        -  All subjects will sign an informed consent statement prior to inclusion in the study.

        -  All subjects will be followed up for 4 weeks and blood samples will be withdrawn at
           baseline, 1 week, and the end of the study to test for ST2 (suppression of
           tumerogenicity 2) biomarker
    

Intervention name(s): Dapagliflozin 10Mg Tab
Intervention type(s): Drug
Intervention description(s): Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) which is a new class of hypoglycemic drugs, and they can block sodium-dependent glucose transporter-2 (SGLT2) located in the early proximal renal tubule to increase urinary glucose excretion and decrease the concentration of blood glucose
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dapagliflozin; ST2; Myocardial infarction; Cardiac remodeling; T2DM