41b41837726c3a60a5dec6a35f69d816 325956.pdf fac47645c890a5e7fe727e5c5013c0f5765835f4 325956.pdf f64560a0a5942dbe8bca557776ab39e31147335b41ac407f8c83fca9efe2d835 325956.pdf Title: Effect of DAPAgliflozin on Myocardial Fibrosis and Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction—DAPA-STEMI Trial Subject: 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. Clinical Trial Registration Unique Identifier: NCT06619600 Keywords: dapagliflozin; myocardial fibrosis; ventricular function; left; myocardial infarction; sodium–glucose transporter 2 inhibitors; cardiac magnetic resonance; randomized controlled trial; ventricular remodeling; heart failure; extracellular space Author: Luis Ortega-Paz, Claudio Laudani, Alessandro Sionis, Pablo Vidal-Cales, Victor Arevalos, Rut Andrea, Carlos Igor Morr, Oriol De Diego, Emilio Ortega, Francisco-Rafael Jimenez-Trinidad, Ana Paula Dantas, Dominick J. Angiolillo, Manel Sabaté, Jose T. Ortiz-Pérez and Salvatore Brugaletta Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Wed Jun 11 12:38:14 2025 CEST ModDate: Wed Jun 11 12:51:59 2025 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 13 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 594384 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- PLOLAK+VnURWPalladioL Type 1 Custom yes yes yes 10 0 KREFUN+URWPalladioL-Roma Type 1 Custom yes yes yes 16 0 JIHLFI+URWPalladioL-Bold Type 1 Custom yes yes yes 22 0 PUOCBL+URWPalladioL-Ital Type 1 Custom yes yes yes 27 0 SDNTQB+CMSY10 Type 1 Builtin yes yes yes 32 0 CJHTVA+CMEX10 Type 1 Builtin yes yes yes 70 0 CZKGAS+CMR10 Type 1 Builtin yes yes yes 75 0 LCMNFB+PalatinoLinotype-Bold CID TrueType Identity-H yes yes yes 86 0 LCMONB+ArialMT TrueType WinAnsi yes yes no 92 0 LCMNHC+PalatinoLinotype-Roman CID TrueType Identity-H yes yes yes 95 0 LCMNHD+PalatinoLinotype-Italic CID TrueType Identity-H yes yes yes 101 0 MPUDFL+PazoMath Type 1 Builtin yes yes yes 111 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2026-02-26 04:18:15 CET RepresentationInformation: 325956.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2026-02-25 14:10:52 CET Size: 594384 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 293 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Methods Destination: section.2 Children: Item: Title: Trial Organization and Sources of Funding Destination: subsection.2.1 Item: Title: Protocol Amendment Destination: subsection.2.2 Item: Title: Patient Eligibility Destination: subsection.2.3 Children: Item: Title: Inclusion Criteria Destination: subsubsection.2.3.1 Item: Title: Exclusion Criteria Destination: subsubsection.2.3.2 Item: Title: Screening Destination: subsection.2.4 Item: Title: Trial Procedures Destination: subsection.2.5 Children: Item: Title: Randomization and Blinding Destination: subsubsection.2.5.1 Item: Title: Data Collection Plan Destination: subsubsection.2.5.2 Item: Title: Follow-Up Visits Destination: subsubsection.2.5.3 Item: Title: Cardiac Magnetic Resonance Imaging Destination: subsubsection.2.5.4 Item: Title: Biomarkers Destination: subsubsection.2.5.5 Item: Title: Drug Discontinuation During the Trial Destination: subsubsection.2.5.6 Item: Title: Trial Outcomes Destination: subsection.2.6 Item: Title: Statistical Considerations Destination: section.3 Children: Item: Title: Monitoring Destination: subsection.3.1 Item: Title: Dissemination Plans Destination: subsection.3.2 Item: Title: Discussion Destination: section.4 Children: Item: Title: Anti-Myocardial Fibrosis and Post-MI Effects of SGLT2i Destination: subsection.4.1 Item: Title: Clinical Evidence for SGLT2is in Post-MI Patients Destination: subsection.4.2 Item: Title: Key Aspects of the Design of the DAPA-STEMI Trial Destination: subsection.4.3 Item: Title: Protocol Amendments and Early Termination Destination: subsection.4.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: appendix.A. Info: Title: Effect of DAPAgliflozin on Myocardial Fibrosis and Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction DAPA-STEMI Trial Author: Luis Ortega-Paz, Claudio Laudani, Alessandro Sionis, Pablo Vidal-Cales, Victor Arevalos, Rut Andrea, Carlos Igor Morr, Oriol De Diego, Emilio Ortega, Francisco-Rafael Jimenez-Trinidad, Ana Paula Dantas, Dominick J. Angiolillo, Manel Sabaté, Jose T. Ortiz-Pérez and Salvatore Brugaletta Subject: 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. 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