Effect of DAPAgliflozin on Myocardial Fibrosis and Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction—DAPA-STEMI Trial

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 ac...

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Published inJournal of cardiovascular development and disease Vol. 12; no. 6; p. 220
Main Authors 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
Format Journal Article
LanguageEnglish
Published Switzerland MDPI AG 11.06.2025
MDPI
Subjects
Biomarkers
Cardiovascular disease
Care and treatment
Chronic illnesses
Collagen
Consent
Dapagliflozin
Design
Dextrose
Diabetes
Ejection fraction
Enrollments
Fibroblasts
Fibrosis
Gadobutrol
Glucose
Heart attack
Heart attacks
Heart failure
Hospitals
left
myocardial fibrosis
myocardial infarction
Patients
Prognosis
sodium–glucose transporter 2 inhibitors
Study Protocol
Transluminal angioplasty
Type 2 diabetes
ventricular function
United States
Spain
heart failure
sodium–glucose transporter 2 inhibitors
left
dapagliflozin
myocardial infarction
ventricular function
ventricular remodeling
extracellular space
cardiac magnetic resonance
myocardial fibrosis
randomized controlled trial
Online AccessGet full text
ISSN2308-3425
2308-3425
DOI10.3390/jcdd12060220

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Abstract 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
AbstractList 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
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.
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
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.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.
Audience Academic
Author De Diego, Oriol
Vidal-Cales, Pablo
Morr, Carlos Igor
Ortega-Paz, Luis
Sionis, Alessandro
Dantas, Ana Paula
Angiolillo, Dominick J.
Laudani, Claudio
Jimenez-Trinidad, Francisco-Rafael
Ortiz-Pérez, Jose T.
Ortega, Emilio
Brugaletta, Salvatore
Arevalos, Victor
Sabaté, Manel
Andrea, Rut
AuthorAffiliation 7 División de Medicina Cardiovascular, Hospital de Clinicas, Universidad Nacional de Asunción, Asunción 2169, Paraguay
5 Division of Cardiology, Centro de Investigación en Red de Enfermedades Cardiovasculares (CIBERCV), 28028 Madrid, Spain
8 Department of Biomedical Sciences, Institut de Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036 Barcelona, Spain adantas@recerca.clinic.cat (A.P.D.)
4 Department of Medicine, Autonomous University of Barcelona, 08193 Barcelona, Spain
9 Department of Biomedical Sciences, School of Medicine and Health Sciences, University of Barcelona, 08193 Barcelona, Spain
10 CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, 28028 Madrid, Spain
3 Cardiological Intensive Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, Sant Pau Biomedical Research Institute (IIB Sant Pau), 08041 Barcelona, Spain; asionis@santpau.cat
6 Cardiology Department, Cardiovascular Clinic Institute, Hospital Clínic de B
AuthorAffiliation_xml – name: 6 Cardiology Department, Cardiovascular Clinic Institute, Hospital Clínic de Barcelona, University of Barcelona, 08193 Barcelona, Spain; pvidalcales@gmail.com (P.V.-C.); varevalos88@gmail.com (V.A.); randrea@clinic.cat (R.A.); morr@clinic.cat (C.I.M.); dediego@clinic.cat (O.D.D.); eortega1@clinic.cat (E.O.); masabate@clinic.cat (M.S.); jtortiz@clinic.cat (J.T.O.-P.); sabrugaletta@gmail.com (S.B.)
– name: 3 Cardiological Intensive Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, Sant Pau Biomedical Research Institute (IIB Sant Pau), 08041 Barcelona, Spain; asionis@santpau.cat
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Issue 6
Keywords heart failure
sodium–glucose transporter 2 inhibitors
left
dapagliflozin
myocardial infarction
ventricular function
ventricular remodeling
extracellular space
cardiac magnetic resonance
myocardial fibrosis
randomized controlled trial
Language English
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These authors contributed equally to this work.
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Snippet Background: Myocardial fibrosis leads to ventricular dysfunction and worsened prognosis, especially after ST-segment elevation myocardial infarction (STEMI)....
Myocardial fibrosis leads to ventricular dysfunction and worsened prognosis, especially after ST-segment elevation myocardial infarction (STEMI)....
Background: Myocardial fibrosis leads to ventricular dysfunction and worsened prognosis, especially after ST-segment elevation myocardial infarction (STEMI)....
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SubjectTerms Biomarkers
Cardiovascular disease
Care and treatment
Chronic illnesses
Collagen
Consent
Dapagliflozin
Design
Dextrose
Diabetes
Ejection fraction
Enrollments
Fibroblasts
Fibrosis
Gadobutrol
Glucose
Heart attack
Heart attacks
Heart failure
Hospitals
left
myocardial fibrosis
myocardial infarction
Patients
Prognosis
sodium–glucose transporter 2 inhibitors
Study Protocol
Transluminal angioplasty
Type 2 diabetes
ventricular function
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Title Effect of DAPAgliflozin on Myocardial Fibrosis and Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction—DAPA-STEMI Trial
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Volume 12
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