Epicardial Cardiac Fat Comparative Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Epicardial fat
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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
研究组 & 干预措施
Dapagliflozin
Dapagliflozin 10 mg daily
干预措施: Dapagliflozin 10 MG Oral Tablet (Drug)
Semaglutide
Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours
干预措施: Semaglutide (Rybelsus®) (Drug)
结局指标
主要结局
Epicardial fat
时间窗: 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.
次要结局
- 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)
研究者
Hilda Elizabeth Macías Cervantes
Ph.D.
Instituto Mexicano del Seguro Social