Ortega-Paz Luis, Laudani Claudio, Sionis Alessandro, Vidal-Cales Pablo, Arevalos Victor, Andrea Rut, Morr Carlos Igor, De Diego Oriol, Ortega Emilio, Jimenez-Trinidad Francisco-Rafael, Dantas Ana Paula, Angiolillo Dominick J, Sabaté Manel, Ortiz-Pérez Jose T, Brugaletta Salvatore
Division of Cardiology, College of Medicine, University of Florida, Jacksonville, FL 32206, USA.
Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco", University of Catania, 95123 Catania, Italy.
J Cardiovasc Dev Dis. 2025 Jun 11;12(6):220. doi: 10.3390/jcdd12060220.
Myocardial fibrosis leads to ventricular dysfunction and worsened prognosis, especially after ST-segment elevation myocardial infarction (STEMI). Sodium-glucose cotransporter 2 inhibitors (SGLT2is) offer cardiovascular benefits by reducing markers of myocardial fibrosis and fibroblast activity. However, the effects of SGLT2i on myocardial fibrosis deposition among STEMI patients undergoing primary percutaneous coronary intervention (PCI) have not yet been evaluated. : The effect of DAPAgliflozin on myocardial fibrosis and ventricular function in patients with STEMI () trial is a phase III, multicenter, randomized, double-blind, placebo-controlled trial. The study aims to assess the effects of dapagliflozin on myocardial fibrosis and ventricular function, evaluated using cardiac magnetic resonance (CMR), in STEMI patients undergoing primary PCI. Eligible patients were 30 to 85 years old and exhibited a left ventricular ejection fraction ≤ 50%. A total of 120 patients with STEMI were expected to be randomized 1:1 to receive dapagliflozin 10 mg or placebo daily for six months. The primary endpoint is the change in the extracellular volume fraction of the remote myocardium from baseline to six months, as measured by CMR. The secondary endpoints include changes in the circulating C-terminal propeptide of type I procollagen, N-terminal propeptide of type III procollagen, and Galectin-3 from baseline to six months. The study was stopped prematurely due to slow recruitment, with 54 enrolled patients, limiting the statistical power to detect changes in the primary endpoint between groups. The DAPA-STEMI trial will provide insights into the impact of dapagliflozin on myocardial fibrosis and ventricular remodeling in patients with STEMI undergoing primary PCI. : NCT06619600.
心肌纤维化会导致心室功能障碍并使预后恶化，尤其是在ST段抬高型心肌梗死（STEMI）后。钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）通过减少心肌纤维化标志物和成纤维细胞活性而带来心血管益处。然而，SGLT2i对接受直接经皮冠状动脉介入治疗（PCI）的STEMI患者心肌纤维化沉积的影响尚未得到评估。达格列净对STEMI患者心肌纤维化和心室功能的影响（DAPA-STEMI）试验是一项III期、多中心、随机、双盲、安慰剂对照试验。该研究旨在评估达格列净对接受直接PCI的STEMI患者心肌纤维化和心室功能的影响，采用心脏磁共振（CMR）进行评估。符合条件的患者年龄在30至85岁之间，左心室射血分数≤50%。预计共有120例STEMI患者将按1:1随机分组，每天接受10 mg达格列净或安慰剂，为期6个月。主要终点是通过CMR测量的从基线到6个月时远隔心肌细胞外容积分数的变化。次要终点包括从基线到6个月时循环中I型前胶原C末端前肽、III型前胶原N末端前肽和半乳糖凝集素-3的变化。由于入组缓慢，该研究提前终止，共入组54例患者，限制了检测组间主要终点变化的统计效力。DAPA-STEMI试验将为达格列净对接受直接PCI的STEMI患者心肌纤维化和心室重构的影响提供见解。：NCT06619600。
