Heart Attack study: SGLT-2 inhibitors
Official title Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
ClinicalTrials.gov ID: NCT05305911
What this study is testing
What is SGLT-2 inhibitors?
This is an investigational daily pill being studied to see if it helps the heart work better after a heart attack. It is designed to help the kidneys remove extra sugar from the blood through urine.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if an SGLT2 inhibitor can improve heart function and reduce heart enlargement after a heart attack.
- Who it's for
- People who have had a heart attack and have an enlarged heart.
- What's involved
- Participants will take either the drug or a placebo once a day for six months, have a cardiac MRI while in the hospital, receive phone check‑ins at 1 and 3 months, and have another MRI and clinic visit at six months.
- Time commitment
- The study lasts six months and includes hospital stays, phone calls, and clinic visits at 1, 3, and 6 months.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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 (assigned by chance patients only)
- Contraindications to gadolinium
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.