Effect of Dapagliflozin on LV Remodeling Post AMI

Study Overview
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Brief Summary
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The overall hypothesis of the study is that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction.

Detailed Description
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In patients with heart failure, with or without diabetes, SGLT2i have shown to decrease remodeling. However, this has not been tested in patients following an acute myocardial infarction. Acute myocardial infarction is serious condition with increasing incidence across the world. Following treatment, a reasonable amount of patients develop remodeling of the left ventricle, which is associated with worse prognosis. This occurs despite patients are treated with GDMT. Dapagliflozin is an SGLT2i with biological plausibility to decrease left ventricular remodeling following acute myocardial infarction. In the present study, researchers will test the hypothesis that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction (less than 7 days). This will be a randomized, single-blind, placebo controlled trial. The primary endpoint will be the change in end-diastolic and end-systolic left ventricular volumes from baseline to the end of the intervention (6 months). We will include patients with acute myocardial infarction who have been treated with primary PCI.

Official Title
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Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Dapagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial infarction treated within the 24 hours of beginning of symptoms Signed informed consent SBP > 90 mmHg Age >= 18 years Exclusion Criteria: Glomerular Filtration Rate < 30 ml/min/1.73 m2. Pregnant or lactating woman Cancer or life-threatening condition Use of continuous parental inotropic agents Psychiatric disease incompatible with being in study. Any contraindication to MRI procedures. Any other medical or physical condition considered to be inappropriate by a study physician Scheduled for a PCI or CABG within the next 6 months Hemodynamic unstability Currently on any SGLT2i One or more episodes of severe hypoglicemia Acute urinary or genital infection

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Dapagliflozin<br>Dapagliflozin 10 mg PO QD | Drug: Dapagliflozin<br>* Dapagliflozin 10 mg PO QD<br>|
| Placebo Comparator: Control<br>Placebo PO QD | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular remodeling | Changes in end-diastolic and end-systolic left ventricular volumes | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natriuretic peptides | Change in natriuretic peptide | 6 months | 
| Quality of life assessed with KCCQ | Change in quality of life | 6 months |