Heart AttackPhase 2NCT05305911
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI
A Phase 2 study testing SGLT-2 inhibitors in people with Heart Attack and Enlarged Heart, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Attack, Enlarged Heart
- What is being tested?
- SGLT-2 inhibitors
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2022to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Sarah Schwager, RN, 612-863-3833, sarah.schwager@allina.com
About this study
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).
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
- Being tested
- SGLT-2 inhibitors, Placebo
- Keywords
- Dapagliflozin, Sodium Glucose Co-Transporter 2
- Medical subject headings
- Myocardial Infarction, Cardiomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitorsDrug
SGLT2 inhibitor once daily for six months
PlaceboDrug
Placebo once daily for six months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SGLT-2 inhibitors |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LVESVI
Change in LVESVI at 6 months as measured by MRI.
Measured: 6 Months
Change in LVEDVI
Change in LVEDVI at 6 months as measured by MRI.
Measured: 6 Months
Secondary outcomes (3)
Change in LV mass
Change in LV mass at 6 months as measured by cMRI
Measured: 6 months
Change in LVEF
Change in LVEF at 6 months as measured by cMRI
Measured: 6 months
MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start3 Aug 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Traverse, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305911
- Sponsor's protocol ID
- 1852152
- Status last verified
- Oct 2024
- First submitted
- 14 Mar 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05305911
- Acronym / sponsor ID
- 1852152
- Conditions
- Heart Attack, Enlarged Heart
- Keywords
- Dapagliflozin, Sodium Glucose Co-Transporter 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: SGLT-2 inhibitorsTreatment 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 | Drug: PlaceboPlacebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Contraindication to cardiac MRI
- Life expectancy < 1 year
- Previous CABG or Valve Surgery
- Previous STEMI
- Pregnant or planning to become pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2 inhibitorsSGLT2 inhibitor once daily for six months | Drug | Treatment Group |
| PlaceboPlacebo once daily for six months | Drug | Placebo Group |
Primary outcome
Change in LVESVI
Time frame: 6 Months
Change in LVESVI at 6 months as measured by MRI.
Change in LVEDVI
Time frame: 6 Months
Change in LVEDVI at 6 months as measured by MRI.
3 secondary outcomes
Change in LV mass
Time frame: 6 months
Change in LVEF
Time frame: 6 months
MACE rates - including hospitalization for CHF, repeat revascularization, MI and death and ICD implantation
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Traverse, MD principal investigator
Minneapolis Heart Institute Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGLT-2 inhibitors in people with Heart Attack and Enlarged Heart, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Schwager, RN (612-863-3833, sarah.schwager@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LVESVI (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.