Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients

Phase 2

Completed

• Conditions: Anterior MI
• Interventions: Drug: Glucose Tab; Drug: Dapagliflozin 10mg

• Registration Number: NCT05424315
• Lead Sponsor: Omar Younis

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 acute myocardial infarction. This study aimed at identifying if there is such role for SGLT2i.

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 (SGLT-2). This is a transmembrane protein found at the luminal border of tubular cells of the proximal convoluted tubules of the kidney. It accounts for around 90% of glucose re-absorption. Inhibiting the SGLT-2 results in better glycemic control in patient with diabetes mellitus type 2 (DMT2).

In heart failure, sodium glucose co-transporter 2 inhibitors (SGLT2i - i.e., gliflozins) were found to have a favorable cardiovascular outcome independent of their anti-glycemic effect. In patients with acute myocardial infarction, the heart function as a pump is affected \& heart failure develops. In particular, patients with anterior ST-elevation myocardial infarction (STEMI) are at a higher risk of remodeling \& heart failure. This is due to the cutoff in blood supply in the left anterior descending (LAD) coronary artery which supplies a great area of left ventricle.

A question that rises: is there a role for SGLT2i, \& in particular dapagliflozin, in acute myocardial infarction in improving post-infarction cardiac function \& preventing heart failure? especially in patients who experience Anterior ST-Elevation Myocardial Infarction (STEMI).

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

1. Patients with Diabetes Miletus (Type 1 (DMT2), Type 1 (DMT1), secondary diabetes (e.g., endocrinopathies)
2. Patients already diagnosed with heart failure prior to this event
3. Patients on cardiotoxic chemotherapeutic medications.
4. Patients with haemoglobinopathies.
5. Patients with chronic organ damage (i.e., chronic hepatitis with MELD score >10, Stage 4 & 5 renal disease).
6. Patients already on SGLT2i.
7. Patients who will require additional anticoagulant therapy (i.e.: patients with transthoracic echocardiographic evidence of left ventricular thrombus).
8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Glucose Tab	Participants will receive a glucose tab once daily.
Intervention Group	Dapagliflozin 10mg	Participants will receive Dapagliflozin 10mg once daily.

Primary Outcome Measures

Name	Time	Method
A change in left ventricular ejection fraction, end-diastolic volume or left ventricular mass index assessed by transthoracic echocardiography at baseline, 4 weeks & 12 weeks post-anterior STEMI	12 weeks	Difference between both groups in the change of the above mentioned echocardiographic parameters assessed at baseline, 4 weeks \& 12 weeks post-anterior STEMI
A change in NT-proBNP levels from baseline to 12 weeks post-anterior STEMI	12 weeks	Difference between both groups in the change of NT-proBNP levels from baseline to 12 weeks post-anterior STEMI

Trial Locations

Locations (2)

Cardiology Department, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt

National Heart Institute; 🇪🇬 Cairo, Egypt