Status:
COMPLETED
Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients
Lead Sponsor:
Omar Younis
Collaborating Sponsors:
Ain Shams University
Conditions:
Anterior MI
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Sodium glucose co-transporter 2 inhibitors (SGLT2i) proved their favorable outcomes in heart failure. However, it is still unknown if their role extent into preventing heart failure, especially after ...
Detailed Description
A notable breakthrough in the management of heart failure is the use of a class of anti-diabetic medications known as, gliflozins. Gliflozins act by inhibiting the sodium glucose co-transporter 2 (SGL...
Eligibility Criteria
Inclusion
- Patients admitted with ECG Criteria for Anterior ST-elevation myocardial infarction according to the fourth universal definition of myocardial infarction\*, \*\* \& show echocardiographic evidence of reduced LV ejection fraction \<50% \& have undergone successful reperfusion by primary percutaneous coronary angiography (pPCI).
- New ST segment elevation in contagious precordial leads consistent anatomically with the anterior wall of myocardium:
- Men ≥ 40 years: 2 mV in leads V2-V3 \&/or 1 mV in other precordial leads
- Men \<40 years: 2.5 mV in leads V2-V3 \&/or 1 mV in other precordial leads
- Women (regardless of age): 1.5 mV in leads V2-V3 \&/or 1 mV in other precordial leads \*\* Patients with admission ECG showing DeWinter's Syndrome, Wellen Syndrome, New onset left bundle branch block, new onset right bundle branch block will also be included.
Exclusion
- Patients with Diabetes Miletus (Type 1 (DMT2), Type 1 (DMT1), secondary diabetes (e.g., endocrinopathies)
- Patients already diagnosed with heart failure prior to this event
- Patients on cardiotoxic chemotherapeutic medications.
- Patients with haemoglobinopathies.
- Patients with chronic organ damage (i.e., chronic hepatitis with MELD score \>10, Stage 4 \& 5 renal disease).
- Patients already on SGLT2i.
- Patients who will require additional anticoagulant therapy (i.e.: patients with transthoracic echocardiographic evidence of left ventricular thrombus).
- Patients with contraindications for use of dapagliflozin including patients with severely impaired renal function (eGFR \<30ml/min/1.73m2) \&/OR previous history of genitourinary infections (i.e.: urosepsis, pyelonephritis \& fournier's gangrene) \&/OR at high risk of such infections.
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05424315
Start Date
October 1 2021
End Date
April 30 2022
Last Update
November 19 2024
Active Locations (2)
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1
Cardiology Department, Faculty of Medicine, Ain Shams University
Cairo, Egypt
2
National Heart Institute
Cairo, Egypt