Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

Phase 2RecruitingNCT05305911

Minneapolis Heart Institute Foundation81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Attack Enlarged Heart

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in LVESVI

Change in LVESVI at 6 months as measured by MRI.

Time frame: 6 Months

Change in LVEDVI

Change in LVEDVI at 6 months as measured by MRI.

Time frame: 6 Months

Secondary Outcomes

Change in LV mass

Change in LV mass at 6 months as measured by cMRI

Time frame: 6 months

Change in LVEF

Change in LVEF at 6 months as measured by cMRI

Time frame: 6 months

MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation

Time frame: 1 year