Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

Phase 2

Recruiting

• Conditions: Heart Attack; Enlarged Heart
• Interventions: Drug: SGLT-2 inhibitors; Drug: Placebo

• Registration Number: NCT05305911
• Lead Sponsor: Minneapolis Heart Institute Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-03-31
• Study Start: 2022-08-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-07
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 81

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	SGLT-2 inhibitors	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.
Placebo Group	Placebo	Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

Primary Outcome Measures

Name	Time	Method
Change in LVEDVI	6 Months	Change in LVEDVI at 6 months as measured by MRI.
Change in LVESVI	6 Months	Change in LVESVI at 6 months as measured by MRI.

Secondary Outcome Measures

Name	Time	Method
Change in LVEF	6 months	Change in LVEF at 6 months as measured by cMRI
MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation	1 year
Change in LV mass	6 months	Change in LV mass at 6 months as measured by cMRI

Trial Locations

Locations (1)

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States