Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

NCT ID: NCT05305911

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-03

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Attack Enlarged Heart

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Treatment will be blinded to the participant and investigator. Assignment of treatment arm will be managed by Abbott Northwestern Heart Hospital pharmacy.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

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.

Group Type ACTIVE_COMPARATOR

SGLT-2 inhibitors

Intervention Type DRUG

SGLT2 inhibitor once daily for six months

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily for six months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SGLT-2 inhibitors

SGLT2 inhibitor once daily for six months

Intervention Type DRUG

Placebo

Placebo once daily for six months

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

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 (randomized patients only)
* Contraindications to gadolinium
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jay Traverse, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute Foundation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sarah Schwager, RN

Role: CONTACT

612-863-3833

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sarah Schwager, RN

Role: primary

612-863-3833

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1852152

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SGLT2i and Incretin and CRTd.
NCT03282136 COMPLETED PHASE4
The Role of SGLT2i in Management of Moderate AS
NCT06469645 RECRUITING PHASE2/PHASE3
Use of SGLT2i in noHCM With HFpEF
NCT06401343 RECRUITING PHASE4