RecruitingPhase 3NCT07297589

Epicardial Cardiac Fat-CT (EPIC-CT)

Epicardial Cardiac Fat Comparative Trial


Sponsor

Instituto Mexicano del Seguro Social

Enrollment

136 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Both globally and nationally, heart disease remains the leading cause of death overall and across genders, with ischemic heart disease being the primary cause. It is now understood that multiple risk factors contribute to the development of this condition, notably type 2 diabetes mellitus and obesity, especially an increase in visceral fat. Among these, the role of epicardial fat volume in the presence of atheromatous plaques in patients with coronary artery disease has been emphasized, along with the link between its volume and the risk of ischemic cardiovascular events. Consequently, recent decades have seen focused research on the potential of epicardial fat as a marker for major adverse cardiac events and on strategies to reduce its volume as a treatment goal for patients with risk factors. Selective sodium-glucose cotransporter 2 inhibitors are drugs that, beyond their antihyperglycemic effect, have demonstrated cardiovascular benefits through various mechanisms, including a reduction in epicardial fat. This was supported by a previous study conducted by our research group, although no statistically significant difference was found. On the other hand, GLP-1 agonists are effective drugs for weight control in patients with severe obesity. However, little research has been done on their effect on more localized fat, such as epicardial fat.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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

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Interventions

DRUGDapagliflozin 10 MG Oral Tablet

10 mg of dapagliflozin daily for 12 months

DRUGSemaglutide (Rybelsus®)

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months


Locations(1)

Unidad Medica de Alta Especialidad No. 1, Bajío

León, Guanajuato, Mexico

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NCT07297589


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