EFFECTS OF ANTIDIABETIC MEDICATION-SGLT2 INHIBITOR IN POST HEART ATTACK PATIENTS WITH HEART FAILURE

Not Applicable

Conditions: Health Condition 1: I219- Acute myocardial infarction, unspecified

Lead Sponsor: Department of Cardiology Kasturba Medical College and Hospital Manipal

Recruitment & Eligibility

Inclusion Criteria

1. Extensive MI

2. LVEF <50%

3. Diagnosed with T2DM, defined as:

• Prior documentation of type 2 diabetes AND/OR

• Treatment with anti-hyperglycemic medications and/or

diet AND/OR

• ADA criteria: fasting >126 mg/dl (7.0 mmol/L) or

HbA1C >=6.5% or 2-h plasma glucose>=200 mg/dl (11.1

mmol/L) during an oral glucose tolerance test, or a

random plasma glucose >= 200 mg/dL (11.1 mmol/L) in

patients with classic symptoms of hyperglycemia or

hyperglycemic crisis.

4. Creatinine clearance of 30 ml or more per minute.

5. Patients on optimal antidiabetic therapy of oral hypoglycemic

agents including SGLT2 inhibitors and/or insulin.

6. On optimal therapy post MI including dual antiplatelets, statins,beta blockers/ARBâ??s/ACE inhibitors, aldosterone antagonists

and/or diuretics, if tolerated.

Exclusion Criteria

1. Severe infection

2. Serious liver or renal functional failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2)

3. Alcohol dependency or use of illicit drugs

4. Pregnant or breastfeeding, possibly pregnant, or planning to become pregnant in the study period (female patients only)

5. Dehydration (abnormal hematocrit [Ht] and blood urea nitrogen, symptoms of dehydration);urinary tract or genital infection

6. History of hypersensitivity to the study drugs

7. Severe ketosis, diabetic coma or precoma

8. Ongoing or past history of pancreatitis

Primary Outcome Measures

Name	Time	Method
The primary outcome measured in this study will be change in LV mass index from baseline to mean of 3-6 months at follow up. <br/ ><br>Secondary outcomes include changes in <br/ ><br>Left Ventricular Ejection fraction <br/ ><br>Area Length Ejection Fraction (ALEF) <br/ ><br>Left ventricular End Diastolic Volume and index <br/ ><br>Left ventricular End Systolic Volume and index <br/ ><br>E/E: ratio between early mitral inflow velocity and mitral annular early diastolic velocity <br/ ><br>Left atrial volume and Index <br/ ><br>LV contractility dp/dt <br/ ><br>Timepoint: 0 AND 6 MONTHS

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include changes in <br/ ><br>Left Ventricular Ejection fraction <br/ ><br>Area Length Ejection Fraction (ALEF) <br/ ><br>Left ventricular End Diastolic Volume and index <br/ ><br>Left ventricular End Systolic Volume and index <br/ ><br>E/E: ratio between early mitral inflow velocity and mitral annular early diastolic velocity <br/ ><br>Left atrial volume and Index <br/ ><br>LV contractility dp/dtTimepoint: 0 AND 6 MONTHS