Overview

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

Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
0
Participant gender:
All
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
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ain Shams University
Treatments:
Dapagliflozin
Criteria
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)