Overview
Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-04-01
2023-04-01
Target enrollment:
0
0
Participant gender:
All
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 patientsPhase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Ain Shams UniversityTreatments:
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)