Health TrialsbyHealthPanel

Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

ConditionsHeart AttackEnlarged Heart
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinneapolis Heart Institute Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication to cardiac MRI

Life expectancy < 1 year

Previous CABG or Valve Surgery

Previous STEMI

Trial design

Design model

Parallel

Treatments tested in this trial

  • SGLT-2 inhibitors

    Drug

    SGLT2 inhibitor once daily for six months

  • Placebo

    Drug

    Placebo once daily for six months

Treatment groups

81 Participants
are divided into 2 treatment groups
Group A: Treatment GroupActive comparator 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in LVESVI

Change in LVESVI at 6 months as measured by MRI.

Time frame
6 Months
2

Change in LVEDVI

Change in LVEDVI at 6 months as measured by MRI.

Time frame
6 Months

Secondary outcomes

1

Change in LV mass

Change in LV mass at 6 months as measured by cMRI

Time frame
6 months
2

Change in LVEF

Change in LVEF at 6 months as measured by cMRI

Time frame
6 months
3

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

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minneapolis Heart Institute Foundation

Lead sponsor

Source ClinicalTrials.gov
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