Status:
COMPLETED
Evaluation of the Effect of SGLT-2 Inhibitors on Cardiac Remodeling in Post Myocardial Infarction Patients
Lead Sponsor:
Ain Shams University
Conditions:
Myocardial Infarction
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 (dapaglifl...
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 y...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05335629
Start Date
June 1 2022
End Date
October 1 2023
Last Update
February 1 2024
Active Locations (1)
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1
Ain shams university hospitals
Cairo, Egypt