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Epicardial Cardiac Fat Comparative Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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%.

Locations
Other Locations
Mexico
Unidad Medica de Alta Especialidad No. 1, Bajío
RECRUITING
León
Contact Information
Primary
Hilda Elizabeth Macías-Cervantes, Ph.D.
hildamacer@gmail.com
4777174800
Backup
Rodolfo Guardado-Mendoza, Ph.D.
guardamen@gmail.com
4772674900
Time Frame
Start Date: 2025-12-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 136
Treatments
Experimental: Dapagliflozin
Dapagliflozin 10 mg daily
Active_comparator: Semaglutide
Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours
Sponsors
Leads: Instituto Mexicano del Seguro Social

This content was sourced from clinicaltrials.gov