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NCT Number: NCT05305911

Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

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.

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Key information

Conditions

Heart Attack Cardiomegaly Cardiovascular Diseases Enlarged Heart Heart Diseases Hypertrophy Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location status: Recruiting

Location contact

Sarah Schwager, RN

CONTACT

[email protected]

612-863-3833

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGLT-2 inhibitors

Drug

SGLT2 inhibitor once daily for six months

Placebo

Drug

Placebo once daily for six months

Primary outcomes

  1. Change in LVESVI

    Time frame: 6 Months

    Change in LVESVI at 6 months as measured by MRI.

  2. Change in LVEDVI

    Time frame: 6 Months

    Change in LVEDVI at 6 months as measured by MRI.

Secondary outcomes

  1. Change in LV mass

    Time frame: 6 months

    Change in LV mass at 6 months as measured by cMRI

  2. Change in LVEF

    Time frame: 6 months

    Change in LVEF at 6 months as measured by cMRI

  3. MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Schwager, RN

CONTACT

[email protected]

612-863-3833

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Registry information

Official study 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).

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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