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NCT Number: NCT07297589

Epicardial Cardiac Fat-CT (EPIC-CT)

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.

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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Epicardial Fat Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unidad Medica de Alta Especialidad No. 1, Bajío

León, Guanajuato, 37260,, Mexico

Location status: Recruiting

Location contact

Hilda E Macias Cervantes, master in clinical research

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin 10 MG Oral Tablet

Drug

10 mg of dapagliflozin daily for 12 months

Semaglutide (Rybelsus®)

Drug

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

Primary outcomes

  1. Epicardial fat

    Time frame: 12 months

    The volume of epicardial fat will be measured using simple coronary tomography during hospitalization for STEMI and after 12 months of treatment with both drugs to evaluate the change.

Secondary outcomes

  1. Change in LDL

    Time frame: 12 months

    The effect of both interventions on LDL levels after 12 months of treatment will be evaluated.

  2. Change in fasting glucose and HbA1c

    Time frame: 12 months

    The impact of both interventions on changes in fasting glucose and HbA1c after 12 months of treatment will be assessed.

  3. Major adverse cardiovascular events (MACE)

    Time frame: 12 months

    During patient follow-up, the occurrence of cardiac failure events, whether requiring hospitalization or not, along with new acute myocardial infarction, cardiovascular death, or stroke, will be evaluated.

  4. Change in body weight

    Time frame: 12 months

    The effect of both interventions on body weight, expressed in kilograms, will be evaluated after 12 months of treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Hilda Elizabeth Macías-Cervantes, Ph.D.

CONTACT

[email protected]

4777174800 ext. 31315

Rodolfo Guardado-Mendoza, Ph.D.

CONTACT

[email protected]

4772674900 ext. 3683

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Epicardial Cardiac Fat Comparative Trial

Acronym: EPIC-CT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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