RECRUITING

Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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).

Quick Facts

Study Start:2022-08-03
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05305911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with their first STEMI (\>18 years) who underwent successful primary PCI and able to give informed consent
  2. * At least mild LV dysfunction (LVEF \< 50%) on echocardiogram, cMRI or Left Ventriculargram following PCI
  3. * Infarct size that is \> 10% of LV mass
  4. * The presence of MVO that is \> 10% of infarct size
  1. * Contraindication to cardiac MRI
  2. * Life expectancy \< 1 year
  3. * Previous CABG or Valve Surgery
  4. * Previous STEMI
  5. * Pregnant or planning to become pregnant or lactating women
  6. * Cardiogenic shock (not resolved)
  7. * Atrial fibrillation or recurrent sustained ventricular arrhythmias (excluding PVCs)
  8. * GFR\<30 ml/min/1.73m2 or end-stage renal disease on dialysis
  9. * Type 1 diabetes mellitus or history of diabetic ketoacidosis
  10. * Type I or II diabetes with insulin use
  11. * Prior intolerance of SGLT2 inhibitors
  12. * Current use of SGLT2 inhibitors (randomized patients only)
  13. * Contraindications to gadolinium

Contacts and Locations

Study Contact

Sarah Schwager, RN
CONTACT
612-863-3833
sarah.schwager@allina.com

Principal Investigator

Jay Traverse, MD
PRINCIPAL_INVESTIGATOR
Minneapolis Heart Institute Foundation

Study Locations (Sites)

Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States

Collaborators and Investigators

Sponsor: Minneapolis Heart Institute Foundation

  • Jay Traverse, MD, PRINCIPAL_INVESTIGATOR, Minneapolis Heart Institute Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-03
Study Completion Date2028-12

Study Record Updates

Study Start Date2022-08-03
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Dapagliflozin
  • Sodium Glucose Co-Transporter 2

Additional Relevant MeSH Terms

  • Heart Attack
  • Enlarged Heart