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).

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 Overview

• Status: Recruiting
• Conditions: Heart Attack; Enlarged Heart
• Intervention / Treatment: Drug: Placebo; Drug: SGLT-2 inhibitors

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sarah Schwager, RN; Phone Number: 612-863-3833; Email: sarah.schwager@allina.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Recruiting
      • Minneapolis Heart Institute Foundation
      • Contact: Sarah Schwager, RN; Phone Number: 612-863-3833; Email: sarah.schwager@allina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.	Drug: Placebo; Placebo once daily for six months
Active Comparator: Treatment Group; 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.	Drug: SGLT-2 inhibitors; SGLT2 inhibitor once daily for six months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LVESVI	Change in LVESVI at 6 months as measured by MRI.	6 Months
Change in LVEDVI	Change in LVEDVI at 6 months as measured by MRI.	6 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Minneapolis Heart Institute Foundation
• Investigators: Principal Investigator: Jay Traverse, MD, Minneapolis Heart Institute Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Dapagliflozin; Sodium Glucose Co-Transporter 2
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Infarction; Hypertrophy; Myocardial Infarction; Cardiomegaly; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: 1852152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes