Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
Primary Purpose
Heart Attack, Enlarged Heart
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Attack focused on measuring Dapagliflozin, Sodium Glucose Co-Transporter 2
Eligibility Criteria
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
Sites / Locations
- Minneapolis Heart Institute FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment Group
Placebo Group
Arm Description
Treatment group will receive dapagliflozin in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
Outcomes
Primary Outcome Measures
Change in LVESVI
Change in LVESVI at 6 months as measured by MRI.
Change in LVEDVI
Change in LVEDVI at 6 months as measured by MRI.
Secondary Outcome Measures
Change in LV mass
Change in LV mass at 6 months as measured by cMRI
Change in LVEF
Change in LVEF at 6 months as measured by cMRI
MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation
Full Information
NCT ID
NCT05305911
First Posted
March 14, 2022
Last Updated
August 4, 2022
Sponsor
Minneapolis Heart Institute Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05305911
Brief Title
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
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).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Minneapolis Heart Institute Foundation
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Attack, Enlarged Heart
Keywords
Dapagliflozin, Sodium Glucose Co-Transporter 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
Treatment group will receive dapagliflozin in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin once daily for six months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily for six months
Primary Outcome Measure Information:
Title
Change in LVESVI
Description
Change in LVESVI at 6 months as measured by MRI.
Time Frame
6 Months
Title
Change in LVEDVI
Description
Change in LVEDVI at 6 months as measured by MRI.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Change in LV mass
Description
Change in LV mass at 6 months as measured by cMRI
Time Frame
6 months
Title
Change in LVEF
Description
Change in LVEF at 6 months as measured by cMRI
Time Frame
6 months
Title
MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Schwager, RN
Phone
612-863-3833
Email
sarah.schwager@allina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Traverse, MD
Organizational Affiliation
Minneapolis Heart Institute Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Schwager, RN
Phone
612-863-3833
Email
sarah.schwager@allina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
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