Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

• Sponsor: Minneapolis Heart Institute Foundation (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05305911
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20.4
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Attack; Enlarged Heart	Drug: Dapagliflozin; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Treatment will be blinded to the participant and study team. Assignment of treatment arm will be managed by Abbott Northwestern Heart Hospital pharmacy
• Primary Purpose: Treatment
• 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).
• Actual Study Start Date: Aug 3, 2022
• Anticipated Primary Completion Date: Apr 15, 2024
• Anticipated Study Completion Date: Apr 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Group Treatment group will receive dapagliflozin in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.	Drug: Dapagliflozin; Dapagliflozin once daily for six months
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.	Drug: Placebo; Placebo once daily for six months

Outcome Measures

Primary Outcome Measures

1. Change in LVESVI [6 Months]

   Change in LVESVI at 6 months as measured by MRI.

2. Change in LVEDVI [6 Months]

   Change in LVEDVI at 6 months as measured by MRI.

Secondary Outcome Measures

1. Change in LV mass [6 months]

   Change in LV mass at 6 months as measured by cMRI

2. Change in LVEF [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 [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	United States	55407

Sponsors and Collaborators

• Minneapolis Heart Institute Foundation

Investigators

• Principal Investigator: Jay Traverse, MD, Minneapolis Heart Institute Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Minneapolis Heart Institute Foundation
• ClinicalTrials.gov Identifier: NCT05305911
• Other Study ID Numbers: 1852152
• First Posted: Mar 31, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Minneapolis Heart Institute Foundation: Dapagliflozin; Sodium Glucose Co-Transporter 2
• Additional relevant MeSH terms: Myocardial Infarction; Cardiomegaly; Dapagliflozin

Study Results

No Results Posted as of Aug 5, 2022