Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

Heart Attack Clinical Trial

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305911
• Other study ID #: 1852152
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: August 2022
• Source: Minneapolis Heart Institute Foundation
• Contact: Sarah Schwager, RN
• Phone: 612-863-3833
• Email: sarah.schwager[@]allina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to determine whether a medication called dapagliflozin will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking the medication dapagliflozin (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with their first STEMI (> 18 years and < 75 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

• Contraindications to gadolinium

Related Conditions & MeSH terms

• Cardiomegaly
• Heart Attack
• Myocardial Infarction

Intervention

Drug:
• Dapagliflozin
Dapagliflozin once daily for six months
• Placebo
Placebo once daily for six months

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LVESVI	Change in LVESVI at 6 months as measured by MRI.	6 Months
Primary	Change in LVEDVI	Change in LVEDVI at 6 months as measured by MRI.	6 Months
Secondary	Change in LV mass	Change in LV mass at 6 months as measured by cMRI	6 months
Secondary	Change in LVEF	Change in LVEF at 6 months as measured by cMRI	6 months
Secondary	MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation		1 year