Using SGLT2 inhibitors to improve heart function after a heart attack
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).
This study is testing if a medication called SGLT2 inhibitors can help improve heart function and reduce heart enlargement in people who have had their first heart attack.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minneapolis Heart Institute Foundation Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05305911 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of SGLT2 inhibitors in enhancing heart function and reducing heart enlargement in patients who have experienced their first STEMI. Participants will take either the medication or a placebo daily for six months, undergo cardiac MRI testing during hospitalization and at the six-month follow-up, and receive phone check-ins at one and three months. The study focuses on patients with mild left ventricular dysfunction following successful primary PCI. It is a single-center, interventional Phase 2 trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have had their first STEMI and exhibit mild left ventricular dysfunction.
Not a fit: Patients with contraindications to cardiac MRI, severe renal impairment, or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart recovery and function in patients after a heart attack.
How similar studies have performed: Previous studies involving SGLT2 inhibitors have shown promising results in heart failure management, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jay Traverse, MD — Minneapolis Heart Institute Foundation
- Study coordinator: Sarah Schwager, RN
- Email: sarah.schwager@allina.com
- Phone: 612-863-3833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.