Epicardial Cardiac Fat Comparative Trial

Official 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 Requirements

• Minimum Age: 18 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 136 participants

Study Arms

• Dapagliflozin (EXPERIMENTAL)
  Dapagliflozin 10 mg daily
• Semaglutide (ACTIVE_COMPARATOR)
  Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours

Interventions

• 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

Primary Outcomes

• Epicardial fat (12 months)

Secondary Outcomes

• Change in LDL (12 months)
• Change in fasting glucose and HbA1c (12 months)
• Major adverse cardiovascular events (MACE) (12 months)
• Change in body weight (12 months)

Eligibility 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

Trial Locations

• Unidad Medica de Alta Especialidad No. 1, Bajío, León, Guanajuato, Mexico

Contact Information

• Hilda Elizabeth Macías-Cervantes, Ph.D. — CONTACT
  Phone: 4777174800
  Email: hildamacer@gmail.com
• Rodolfo Guardado-Mendoza, Ph.D. — CONTACT
  Phone: 4772674900
  Email: guardamen@gmail.com

Study Officials

• Rodolfo Guardado-Mendoza, Ph.D. — STUDY_CHAIR
  Universidad de Guanajuato

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