Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients

All patients presenting to the Clinical Cardiology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:

Inclusion criteria

• Female or male aged >18 and < 75 years
• Diabetic post myocardial infarction patients
• First anterior STEMI with successful TIMI-3 flow
• STEMI within 12 hrs of onset of chest pain
• creatine clearance ≥60 mL/min
• HbA1c between 6.5% and 12.0%

Exclusion criteria

• Cardiogenic shock on admission
• Multivessel disease on admission
• Mechanical complications e.g. mitral regurge on admission
• Life threatening arrhythmia on admission
• Hemodynamic instability on admission
• Diagnosis of Type 1 diabetes mellitus
• History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
• Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
• Pregnant or breast-feeding patients
• Active participation in another clinical study
• AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
• CrCl < 60 ml/min (based on the Cockroft-Gault equation)

Eligible patients will be randomly assigned into one of 2 arms:

• Group 1 (Healthy control) (n=10) Aged-matched healthy volunteers who do not suffer any diseases.
• Group 2 (Control group) (n= 30): Post-MI patients who will receive standard of care for 4 Weeks
• 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• All subjects will be followed up for 4 weeks and blood samples will be withdrawn at baseline, 1 week, and the end of the study to test for ST2 (suppression of tumerogenicity 2) biomarker

Inclusion criteria

• Female or male aged >18 and < 75 years
• Diabetic post myocardial infarction patients
• First anterior STEMI with successful TIMI-3 flow
• STEMI within 12 hrs of onset of chest pain
• creatine clearance ≥60 mL/min
• HbA1c between 6.5% and 12.0%

Exclusion criteria

• Cardiogenic shock on admission
• Multivessel disease on admission
• Mechanical complications e.g. mitral regurge on admission
• Life threatening arrhythmia on admission
• Hemodynamic instability on admission
• Diagnosis of Type 1 diabetes mellitus
• History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
• Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
• Pregnant or breast-feeding patients
• Active participation in another clinical study
• AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
• CrCl < 60 ml/min (based on the Cockroft-Gault equation)