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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Active Comparator | 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 Group | Placebo Comparator | Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT-2 inhibitors | Drug | SGLT2 inhibitor once daily for six months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LVESVI | Change in LVESVI at 6 months as measured by MRI. | 6 Months |
| Change in LVEDVI | Change in LVEDVI at 6 months as measured by MRI. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LV mass | Change in LV mass at 6 months as measured by cMRI | 6 months |
| Change in LVEF | Change in LVEF at 6 months as measured by cMRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Schwager, RN | Contact | 612-863-3833 | sarah.schwager@allina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jay Traverse, MD | Minneapolis Heart Institute Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis Heart Institute Foundation | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D006332 | Cardiomegaly |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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Treatment will be blinded to the participant and investigator. Assignment of treatment arm will be managed by Abbott Northwestern Heart Hospital pharmacy.
| Placebo |
| Drug |
Placebo once daily for six months |
|
| 6 months |
| MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation | 1 year |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D045505 | Physiological Effects of Drugs |