Effect of DAPAgliflozin on Myocardial Fibrosis and Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction-DAPA-STEMI Trial
Por:
Ortega-Paz, L, Laudani, C, Sionis, A, Vidal-Cales, P, Arevalos, V, Andrea, R, Morr, CI, De Diego, O, Ortega, E, Jimenez-Trinidad, FR, Dantas, AP, Angiolillo, DJ, Sabaté, M, Ortiz-Pérez, JT, Brugaletta, S
Publicada:
11 jun 2025
Resumen:
Background: 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. Study and Design: The effect of DAPAgliflozin on myocardial fibrosis and ventricular function in patients with STEMI (DAPA-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. Conclusions: 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.
Filiaciones:
Ortega-Paz, L:
Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL 32206 USA
Laudani, C:
Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL 32206 USA
Univ Catania, Azienda Osped Univ Policlin G Rodolico San Marco, Div Cardiol, I-95123 Catania, Italy
Sionis, A:
Hosp Santa Creu & Sant Pau, St Pau Biomed Res Inst IIB St Pau, Cardiol Dept, Cardiol Intens Care Unit, Barcelona 08041, Spain
Autonomous Univ Barcelona, Dept Med, Barcelona 08193, Spain
Ctr Invest Red Enfermedades Cardiovasc CIBERCV, Div Cardiol, Madrid 28028, Spain
Vidal-Cales, P:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Arevalos, V:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Univ Nacl Asuncion, Hosp Clin, Div Med Cardiovasc, Asuncion 2169, Paraguay
Andrea, R:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Dept Biomed Sci, Barcelona 08036, Spain
Univ Barcelona, Sch Med & Hlth Sci, Dept Biomed Sci, Barcelona 08193, Spain
Morr, CI:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
De Diego, O:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Univ Nacl Asuncion, Hosp Clin, Div Med Cardiovasc, Asuncion 2169, Paraguay
Ortega, E:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Dept Biomed Sci, Barcelona 08036, Spain
Univ Barcelona, Sch Med & Hlth Sci, Dept Biomed Sci, Barcelona 08193, Spain
Inst Salud Carlos III, CIBER Fisiopatol Obes & Nutr CIBEROBN, Madrid 28028, Spain
Jimenez-Trinidad, FR:
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Dept Biomed Sci, Barcelona 08036, Spain
Univ Barcelona, Sch Med & Hlth Sci, Dept Biomed Sci, Barcelona 08193, Spain
Dantas, AP:
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Dept Biomed Sci, Barcelona 08036, Spain
Univ Barcelona, Sch Med & Hlth Sci, Dept Biomed Sci, Barcelona 08193, Spain
Angiolillo, DJ:
Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL 32206 USA
Sabaté, M:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Dept Biomed Sci, Barcelona 08036, Spain
Univ Barcelona, Sch Med & Hlth Sci, Dept Biomed Sci, Barcelona 08193, Spain
Ortiz-Pérez, JT:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Brugaletta, S:
Univ Barcelona, Hosp Clin Barcelona, Cardiovasc Clin Inst, Cardiol Dept, Barcelona 08193, Spain
Inst Invest Biomed August Pi i Sunyer IDIBAPS, Dept Biomed Sci, Barcelona 08036, Spain
Univ Barcelona, Sch Med & Hlth Sci, Dept Biomed Sci, Barcelona 08193, Spain
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