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

Last updated: November 16, 2024
Sponsor: Omar Younis
Overall Status: Completed

Phase

2/3

Condition

Congestive Heart Failure

Blood Clots

Myocardial Ischemia

Treatment

Glucose Tab

Dapagliflozin 10mg

Clinical Study ID

NCT05424315
CTN1012021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients admitted with ECG Criteria for Anterior ST-elevation myocardial infarctionaccording to the fourth universal definition of myocardial infarction*, ** & showechocardiographic evidence of reduced LV ejection fraction <50% & have undergonesuccessful reperfusion by primary percutaneous coronary angiography (pPCI).

  • New ST segment elevation in contagious precordial leads consistent anatomicallywith 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 otherprecordial leads ** Patients with admission ECG showing DeWinter'sSyndrome, Wellen Syndrome, New onset left bundle branch block, new onsetright bundle branch block will also be included.

Exclusion

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 withtransthoracic echocardiographic evidence of left ventricular thrombus).

  8. Patients with contraindications for use of dapagliflozin including patients withseverely impaired renal function (eGFR <30ml/min/1.73m2) &/OR previous history ofgenitourinary infections (i.e.: urosepsis, pyelonephritis & fournier's gangrene) &/OR at high risk of such infections.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Glucose Tab
Phase: 2/3
Study Start date:
October 01, 2021
Estimated Completion Date:
April 30, 2022

Study 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).

Connect with a study center

  • Cardiology Department, Faculty of Medicine, Ain Shams University

    Cairo,
    Egypt

    Site Not Available

  • National Heart Institute

    Cairo,
    Egypt

    Site Not Available

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