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).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05305911

Enrollment

Registered

2022-03-31

Start date

2022-08-03

Completion date

2028-12-31

Last updated

2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Attack, Enlarged Heart

Keywords

Dapagliflozin, Sodium Glucose Co-Transporter 2

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.

Interventions

DRUGSGLT-2 inhibitors

SGLT2 inhibitor once daily for six months

DRUGPlacebo

Placebo once daily for six months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Treatment will be blinded to the participant and investigator. Assignment of treatment arm will be managed by Abbott Northwestern Heart Hospital pharmacy.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in LV mass	6 months	Change in LV mass at 6 months as measured by cMRI
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	—

Countries

United States

Contacts

Primary ContactSarah Schwager, RN

sarah.schwager@allina.com612-863-3833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026