Recruiting
Phase 2

SGLT2 Inhibitor

Sponsor:

Minneapolis Heart Institute Foundation

Code:

NCT05305911

Conditions

Heart Attack

Enlarged Heart

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SGLT-2 inhibitors

Placebo

Study Details

Brief summary:

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.

Conditions

Heart Attack

Enlarged Heart

Study ID

NCT05305911

Start date

Aug 3, 2022

Status verified date

Oct, 2024

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

81 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment Group

Treatment group will receive SGLT2 inhibitor in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

placebo comparator: Placebo Group

Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

Interventions

SGLT-2 inhibitors

SGLT2 inhibitor once daily for six months

Placebo

Placebo once daily for six months

Primary outcome measure

  • Change in LVESVI [ Time Frame: 6 Months ]
  • Change in LVEDVI [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Sarah Schwager, RN

612-863-3833sarah.schwager@allina.com

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Sarah Schwager, RN

612-863-3833sarah.schwager@allina.com

More Information

Sponsor

Minneapolis Heart Institute Foundation

Last update posted

Oct 8, 2024

Last verified

Oct, 2024

Keywords

  • Dapagliflozin
  • Sodium Glucose Co-Transporter 2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Minneapolis Heart Institute Foundation on 2024-10-08.