NCT05305911 · Minneapolis Heart Institute Foundation
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
What this study is about
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.
View original scientific description
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
DRUG
SGLT-2 inhibitors
SGLT2 inhibitor once daily for six months
DRUG
Placebo
Placebo once daily for six months
Primary outcome measures
Change in LVESVI
Time frame: 6 Months
Change in LVESVI at 6 months as measured by MRI.
Change in LVEDVI
Time frame: 6 Months
Change in LVEDVI at 6 months as measured by MRI.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2024 · Source of record for eligibility and locations