NCT05305911PHASE2Recruiting
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
Minneapolis Heart Institute Foundation
Start Date
8/3/2022
Completion Date
12/1/2028
Summary
The purpose of the research is to determine whether a class of medication called SGLT2 inhibitor will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking this class of medication (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. This is a single center study.
Eligibility Criteria
Age Range: 18 years to 75 years
Inclusion Criteria:
* Patients with their first STEMI (\>18 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 (randomized patients only)
* Contraindications to gadolinium
Interventions
DRUG
SGLT-2 inhibitors
DRUG
Placebo
Conditions
Heart AttackEnlarged Heart
Locations
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
United States