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

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of the Effect of Dapagliflozin on Cardiac Remodeling in Post Myocardial Infarction Patients

Conditions
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Myocardial Infarction, Diabetes Mellitus, Type 2, Myocardial Remodeling, Ventricular

Intervention / Treatment
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* Drug: Dapagliflozin 10Mg Tab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>30 patients will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks Interventions: Drug: Dapagliflozin 10 mg oral tablets Standard of care: Dual antiplatelet therapy, Statin, anticoagulation therapy | Drug: Dapagliflozin 10Mg Tab<br>* 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<br>|
| No Intervention: Control arm<br>30 patients will receive standard of care (Dual antiplatelet therapy, Statin, anticoagulation therapy) for 4 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction | patients will be followed up for the whole period of the study and blood sample will be drawn at baseline and at study end to track changes in the level of ST2 (suppression of tumerogenicity 2) which is a cardiac remodeling biomarker using ELISA technique | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic changes due to intervention | patients will have their echocardiography and ejection fraction will be compared at baseline and at the end of the study to track any changes that may be caused by intervention | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST2, Dapagliflozin, Myocardial infarction, Cardiac remodeling, T2DM