NCT07297589

Epicardial Cardiac Fat-CT (EPIC-CT)

Epicardial Cardiac Fat Comparative Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized, open-label clinical trial will assess the effects of dapagliflozin compared to semaglutide on epicardial fat in patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction over a 12-month period. Epicardial fat will be measured by simple coronary tomography during initial hospitalization for infarction and after 12 months of treatment with both medications. It will include patients over 18 years old with STEMI and NSTEMI, with or without a diagnosis of type 2 diabetes and clinical obesity. Patients will be discharged following treatment guidelines, and their adherence to medication and tolerability will be monitored.

Conditions

• STEMI - ST Elevation Myocardial Infarction
• Epicardial Fat

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10 MG Oral Tablet	10 mg of dapagliflozin daily for 12 months
DRUG	Semaglutide (Rybelsus®)	Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months

Timeline

• Start date: 2025-12-30
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2025-12-22
• Last updated: 2026-01-02

Locations

1 site across 1 country: Mexico