Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

Minneapolis Heart Institute Foundation

Status and phase: Enrolling; Phase 2

Conditions: Heart Attack; Enlarged Heart

Treatments: Drug: Placebo; Drug: SGLT-2 inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT05305911

1852152

Details and patient eligibility

About

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

81 participants in 2 patient groups, including a placebo group

Treatment Group

Active Comparator group

Description:

Treatment group will receive SGLT2 inhibitor in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

Treatment:

Drug: SGLT-2 inhibitors

Placebo Group

Placebo Comparator group

Description:

Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

Treatment:

Drug: Placebo