NCT05305911 Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
| NCT ID | NCT05305911 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Minneapolis Heart Institute Foundation |
| Condition | Heart Attack |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2022-08-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 81 participants in total. It began in 2022-08-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Jay Traverse, MD
PRINCIPAL INVESTIGATOR
Minneapolis Heart Institute Foundation
Frequently Asked Questions
Who can join the NCT05305911 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Heart Attack. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05305911 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05305911 currently recruiting?
Yes, NCT05305911 is actively recruiting participants. Contact the research team at sarah.schwager@allina.com for enrollment information.
Where is the NCT05305911 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05305911 clinical trial?
NCT05305911 is sponsored by Minneapolis Heart Institute Foundation. The principal investigator is Jay Traverse, MD at Minneapolis Heart Institute Foundation. The trial plans to enroll 81 participants.