Epicardial fat CT in patients after heart attack
Epicardial Cardiac Fat Comparative Trial
PHASE3 · Instituto Mexicano del Seguro Social · NCT07297589
This trial will test whether dapagliflozin or semaglutide reduces epicardial (around-the-heart) fat over 12 months in adults hospitalized with ST-elevation or non‑ST‑elevation myocardial infarction.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Mexicano del Seguro Social (other gov) |
| Locations | 1 site (León, Guanajuato) |
| Trial ID | NCT07297589 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label Phase 3 comparison of dapagliflozin 10 mg versus oral semaglutide (Rybelsus) given for 12 months. Epicardial fat volume will be measured by coronary CT during the initial hospitalization for infarction and again at 12 months. The trial enrolls adults with STEMI or NSTEMI who meet the protocol's clinical and laboratory criteria, and patients receive standard post‑MI care while adherence and tolerability are monitored. Key exclusions include recent immunosuppression, active infection, cancer, pancreatitis, hemodynamic instability, pregnancy, and prior long-term use of the study drugs.
Who should consider this trial
Good fit: Adults hospitalized with STEMI or NSTEMI who are clinically obese (often with elevated hs‑CRP), have preserved LVEF, and can start and tolerate either dapagliflozin or semaglutide are the intended candidates.
Not a fit: Patients who are pregnant, hemodynamically unstable, have active infections, cancer, pancreatitis, recent immunosuppression, a prior history of ischemic heart disease, or recent long-term use of the study drugs are excluded and unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, one or both drugs could reduce epicardial fat and potentially lower the risk of future ischemic cardiac events after myocardial infarction.
How similar studies have performed: Large outcome trials have shown cardiovascular benefits for SGLT2 inhibitors and GLP‑1 receptor agonists and smaller imaging studies report reductions in visceral and epicardial fat, but direct head‑to‑head post‑MI comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Criteria for the fourth definition of acute myocardial infarction with and without ST-segment elevation. * Diagnosed with type 2 diabetes. * Initial serum high-sensitivity CRP value \> 2.0 mg/L. * Clinically obese. * LVEF \>50%. Exclusion Criteria: * Patients who have recently received immunosuppressive therapy * Patients with a history of ischemic heart disease * Known allergy to any of the medications used * Use of any of the study drugs more than 6 months prior to randomization * Patients experiencing diabetic ketoacidosis * Patients with hemodynamic instability (mean arterial pressure \<60 mmHg while on vasopressors) * Pregnant women * Patients with a history or current diagnosis of cancer * Patients with documented active infections, such as pneumonia or urinary tract infections * Patients with pancreatitis
Where this trial is running
León, Guanajuato
- Unidad Medica de Alta Especialidad No. 1, Bajío — León, Guanajuato, Mexico (RECRUITING)
Study contacts
- Study coordinator: Hilda Elizabeth Macías-Cervantes, Ph.D.
- Email: hildamacer@gmail.com
- Phone: 4777174800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: STEMI - ST Elevation Myocardial Infarction, Epicardial Fat, Epicardial fat, STEMI, Semaglutide, Dapagliflozin