Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

Study Overview
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Brief Summary
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The purpose of the research is to determine whether a medication called dapagliflozin will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking the medication dapagliflozin (or a placebo) once daily for six months, one cardiac magnetic resonance imaging (MRI) test during your initial hospitalization, follow-up phone calls at 1 and 3 months, and one cardiac MRI and clinic visit at six months.

Official Title
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Sodium Glucose Co-Transporter 2 (SGLT2) Inhibition Improves Left Ventricular Function and Reduces Adverse Left-Ventricular Remodeling in High-Risk Patients With Microvascular Obstruction (MVO) Following ST-elevation Myocardial Infarction (STEMI).

Conditions
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Heart Attack, Enlarged Heart

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with their first STEMI (> 18 years and < 75 years) who underwent successful primary PCI and able to give informed consent At least mild LV dysfunction (LVEF < 50%) on echocardiogram, cMRI or Left Ventriculargram following PCI Infarct size that is > 10% of LV mass The presence of MVO that is > 10% of infarct size Exclusion Criteria: Contraindication to cardiac MRI Life expectancy < 1 year Previous CABG or Valve Surgery Previous STEMI Pregnant or planning to become pregnant or lactating women Cardiogenic shock (not resolved) Atrial fibrillation or recurrent sustained ventricular arrhythmias (excluding PVCs) GFR<30 ml/min/1.73m2 or end-stage renal disease on dialysis Type 1 diabetes mellitus or history of diabetic ketoacidosis Type I or II diabetes with insulin use Prior intolerance of SGLT2 inhibitors Current use of SGLT2 inhibitors Contraindications to gadolinium

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Group<br>Treatment group will receive dapagliflozin in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study. | Drug: Dapagliflozin<br>* Dapagliflozin once daily for six months<br>|
| Placebo Comparator: Placebo Group<br>Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study. | Drug: Placebo<br>* Placebo once daily for six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LVESVI | Change in LVESVI at 6 months as measured by MRI. | 6 Months | 
| Change in LVEDVI | Change in LVEDVI at 6 months as measured by MRI. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LV mass | Change in LV mass at 6 months as measured by cMRI | 6 months | 
| Change in LVEF | Change in LVEF at 6 months as measured by cMRI | 6 months | 
| MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapagliflozin, Sodium Glucose Co-Transporter 2