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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003105-25 | EudraCT Number |
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The DAPA-STEMI trial investigates whether dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), reduces heart muscle scarring (fibrosis) and improves heart function after a ST-segment elevation myocardial infarction (STEMI). The trial will use cardiac MRI to measure changes in heart structure and function over six months. Patients aged 30-85 who have had a recent STEMI will receive either dapagliflozin or a placebo. The study aims to provide mechanistic insights into heart failure prevention after heart attacks.
The DAPA-STEMI trial is a clinical research study designed to investigate whether dapagliflozin, a medication known as a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can reduce the extent of heart muscle damage and improve heart function in patients who have experienced a heart attack. Specifically, the study focuses on patients who have had a type of heart attack known as a ST-segment elevation myocardial infarction (STEMI), which is a serious condition that often leads to long-term heart damage and heart failure.
The study aims to answer whether treatment with dapagliflozin can reduce the amount of scarring (fibrosis) that develops in the heart after a heart attack, and whether this reduction in scarring improves the overall function of the heart. Scarring in the heart can lead to stiffening of the heart muscle, which affects its ability to pump blood effectively and can result in heart failure. By using advanced imaging techniques, such as cardiac magnetic resonance imaging (MRI), the study will measure changes in the heart's structure and function over time.
The primary question the study seeks to answer is whether dapagliflozin can decrease the amount of heart muscle scarring (fibrosis) and improve heart function when compared to a placebo (an inactive treatment). The study will also examine whether dapagliflozin affects other important heart health markers, such as blood levels of proteins that indicate heart muscle damage and the overall size and function of the heart chambers.
The study will enroll patients aged 30 to 85 who have recently experienced a STEMI and undergone successful treatment to open the blocked artery. Participants will be randomly assigned to receive either dapagliflozin or a placebo for six months, and their heart function and scarring will be monitored through imaging and blood tests during that time.
The results of this study may provide important insights into new ways to protect the heart after a heart attack and prevent the development of heart failure, offering potential benefits to a wide range of patients who experience heart attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10 mg qd |
|
| Placebo | Placebo Comparator | Matched placebo qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Dapagliflozin 10 mg qd |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Extracellular volume (ECV, %) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the extracellular volume (ECV) of the remote myocardium between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔECV dapagliflozin group versus ΔECV placebo group; [ΔECV = ECV 6-month - ECV baseline]). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum levels of C-terminal propeptide of type I procollagen (PICP) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of C-terminal propeptide of type I procollagen (PICP) between the 6-month and baseline follow- up (ΔPICP dapagliflozin group versus ΔPICP placebo group; [ΔPICP = PICP 6-month - PICP baseline]). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| N-terminal pro-brain natriuretic peptide (NT-proBNP) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) between the 6-month and baseline follow- up (NT-proBNP dapagliflozin group versus NT-proBNP placebo group; [ΔNT-proBNP = NT-proBNP 6-month - NT-proBNP baseline]). | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Ortega, MD, PhD | Division of Cardiology, University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA. | Principal Investigator |
| Salvatore Brugaletta, MD, PhD | Hospital Clínic, Cardiovascular Clinic Institute, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08025 | Spain | ||
| Hospital Clinic of Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27544605 | Background | Perea RJ, Morales-Ruiz M, Ortiz-Perez JT, Bosch X, Andreu D, Borras R, Acosta J, Penela D, Prat-Gonzalez S, de Caralt TM, Martinez M, Morales-Romero B, Lasalvia L, Donnelly J, Jimenez W, Mira A, Mont L, Berruezo A. Utility of galectin-3 in predicting post-infarct remodeling after acute myocardial infarction based on extracellular volume fraction mapping. Int J Cardiol. 2016 Nov 15;223:458-464. doi: 10.1016/j.ijcard.2016.08.070. Epub 2016 Aug 8. | |
| 36303443 |
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| Drug |
Matched placebo qd |
|
| N-terminal propeptide of type III (PIIINP) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of N-terminal propeptide of type III (PIIINP) between the 6-month and baseline follow- up (ΔPIIINP dapagliflozin group versus ΔPIIINP placebo group; [ΔPIIINP = PIIINP 6-month - PIIINP baseline]). | 6 months |
| Galectin-3 procollagen (Gal-3) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of galectin-3 procollagen (Gal-3) between the 6-month and baseline follow- up (ΔGal-3 dapagliflozin group versus ΔGal-3 placebo group; [ΔGal-3 = Gal-3 6-month - Gal-3 baseline]). | 6 months |
| High-Sensitivity cardiac Troponin I (hs-cTnI) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of High-Sensitivity cardiac Troponin I (hs-cTnI) between the 6-month and baseline follow- up (hs-cTnI dapagliflozin group versus hs-cTnI placebo group; [Δhs-cTnI = hs-cTnI 6-month - hs-cTnI baseline]). | 6 months |
| Soluble suppression of tumorigenicity 2 (sST2) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the serum levels of Soluble suppression of tumorigenicity 2 (sST2) between the 6-month and baseline follow- up (sST2 dapagliflozin group versus sST2 placebo group; [ΔsST2 = sST2 6-month - sST2 baseline]). | 6 months |
| Indexed ventricular mass of the left ventricle (LVMI, g/m^2) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed ventricular mass of the left ventricle (LVMI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVMI dapagliflozin group versus ΔLVMI placebo group; [ΔLVMI = LVMI 6-month - LVMI baseline]). | 6 months |
| Indexed End-diastolic volume of the left ventricle (LVEDVI, mL/m^2) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed End-diastolic volume of the left ventricle (LVEDVI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVEDVI dapagliflozin group versus ΔLVEDVI placebo group; [ΔLVEDVI = LVEDVI 6-month - LVEDVI baseline]). | 6 months |
| Indexed End-systolic volume of the left ventricle (LVESVI, mL/m^2) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Indexed End-systolic volume of the left ventricle (LVESVI) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVESVI dapagliflozin group versus ΔLVESVI placebo group; [ΔLVESVI = LVESVI 6-month - LVESVI baseline]). | 6 months |
| Left ventricular ejection fraction (LVEF, %) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Left ventricular ejection fraction (LVEF) between the 6-month and baseline follow- up, evaluated by cardiac magnetic resonance (ΔLVEF dapagliflozin group versus ΔLVEF placebo group; [ΔLVEF = LVEF 6-month - LVEF baseline]). | 6 months |
| Body weight (BW, Kgs) | To determine the effect of dapagliflozin compared with placebo in the change (Δ) of the Body weight (BW) between the 6-month and baseline follow- up, (ΔBW dapagliflozin group versus ΔBW placebo group; [ΔBW = BW 6-month - BW baseline]). | 6 months |
| Major Adverse Cardiovascular Events (MACE) | Difference in the incidence of Major Adverse Cardiovascular Events (MACE), defined as a composite of death, non-fatal myocardial infarction, and non-fatal stroke, between the dapagliflozin and placebo groups. | 6 months |
| Hospitalizations for Heart Failure (HHF) | Difference in the incidence of Hospitalizations for Heart Failure (HHF) between the dapagliflozin and placebo groups. | 6 months |
| Barcelona |
| Catalonia |
| 08036 |
| Spain |
| Background |
| Ortega-Paz L, Cristobal H, Ortiz-Perez JT, Garcia de Frutos P, Mendieta G, Sandoval E, Rodriguez JJ, Ortega E, Garcia-Alvarez A, Brugaletta S, Sabate M, Dantas AP. Direct actions of dapagliflozin and interactions with LCZ696 and spironolactone on cardiac fibroblasts of patients with heart failure and reduced ejection fraction. ESC Heart Fail. 2023 Feb;10(1):453-464. doi: 10.1002/ehf2.14186. Epub 2022 Oct 27. |
| 40558655 | Derived | 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, Sabate M, Ortiz-Perez JT, Brugaletta S. Effect of DAPAgliflozin on Myocardial Fibrosis and Ventricular Function in Patients with ST-Segment Elevation Myocardial Infarction-DAPA-STEMI Trial. J Cardiovasc Dev Dis. 2025 Jun 11;12(6):220. doi: 10.3390/jcdd12060220. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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