RecruitingPhase 2NCT05305911

Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

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).


Sponsor

Minneapolis Heart Institute Foundation

Enrollment

81 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria13

  • 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

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Interventions

DRUGSGLT-2 inhibitors

SGLT2 inhibitor once daily for six months

DRUGPlacebo

Placebo once daily for six months


Locations(1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

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NCT05305911


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