NCT05305911RecruitingPhase 2
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).
Source: ClinicalTrials.gov · Last updated 8 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (estimated)
- First submitted
- 14 Mar 2022
- Start date
- 3 Aug 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Diseases
- Coronary artery disease
- NCT number
- NCT05305911
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 81
- From 3 Aug 2022 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous CABG or Valve Surgery
- Previous STEMI
- Prior intolerance of SGLT2 inhibitors
- Current use of SGLT2 inhibitors (randomized patients only)
Other illness
- Contraindication to cardiac MRI
- Atrial fibrillation or recurrent sustained ventricular arrhythmias (excluding PVCs)
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Type I or II diabetes with insulin use
Lab values
- GFR\<30 ml/min/1.73m2 or end-stage renal disease on dialysis
Other
- Life expectancy \< 1 year
- Pregnant or planning to become pregnant or lactating women
- Cardiogenic shock (not resolved)
- Contraindications to gadolinium
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Minneapolis Heart Institute Foundation Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.