Epicardial Cardiac Fat-CT (EPIC-CT)

Instituto Mexicano del Seguro Social

Status and phase: Enrolling; Phase 3

Conditions: Epicardial Fat; STEMI - ST Elevation Myocardial Infarction

Treatments: Drug: Dapagliflozin 10 MG Oral Tablet; Drug: Semaglutide (Rybelsus®)

Study type: Interventional

Funder types: Other

Identifiers

NCT07297589

R-2025-1001-087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Dapagliflozin

Experimental group

Description:

Dapagliflozin 10 mg daily

Treatment:

Drug: Dapagliflozin 10 MG Oral Tablet

Semaglutide

Active Comparator group

Description:

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours

Treatment:

Drug: Semaglutide (Rybelsus®)