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Recruiting NCT05305911

Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

Phase II Interventional Heart Attack Enlarged Heart

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SGLT-2 inhibitors, Placebo.
Who it may be relevant to
Registry conditions: Heart Attack, Enlarged Heart. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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).

Overview

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 LVEDVI [Time frame: 6 Months]
Secondary outcome measures (3)
  • Change in LV mass [Time frame: 6 months]
  • Change in LVEF [Time frame: 6 months]
  • MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Minneapolis Heart Institute Foundation — Minneapolis

Identifiers

NCT: NCT05305911 · 1852152

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗