Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
Purpose
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.
Conditions
- Heart Attack
- Enlarged Heart
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
More Details
- Status
- Recruiting
- Sponsor
- Minneapolis Heart Institute Foundation