The Effect of Sodium Glucose Co-trnasportert Type 2 Inhibitors on Arterial Stiffness, Endothelial Glycocalyx Thickness and Cardiac Deformation After Acute Myocardial Infarction

NCT07469943 | Recruiting

• 1 other identifier: 70/09-03-2026
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Acute myocardial infarction (MI) remains one of the leading causes of cardiovascular morbidity and mortality worldwide. It most commonly occurs due to acute coronary artery occlusion following rupture or erosion of an atherosclerotic plaque and subsequent thrombus formation. Despite significant advances in reperfusion strategies and guideline-directed pharmacological therapy, patients who survive MI remain at increased risk for adverse cardiovascular outcomes, including heart failure, recurrent myocardial infarction, stroke, and cardiovascular death. Therefore, additional therapeutic strategies that may improve vascular function, myocardial remodeling, and overall cardiovascular prognosis following MI are of considerable clinical interest. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have recently emerged as an important pharmacological class with significant cardiometabolic benefits. Large randomized clinical trials have demonstrated that SGLT2 inhibitors reduce the risk of hospitalization for heart failure and cardiovascular mortality in patients with type 2 diabetes mellitus and in patients with heart failure irrespective of diabetic status. The cardioprotective effects of these agents appear to extend beyond glycemic control and include improvements in myocardial energetics, vascular function, inflammation, and oxidative stress. Emerging evidence suggests that SGLT2 inhibitors may also exert beneficial effects on vascular stiffness, endothelial function, and myocardial remodeling. However, data regarding their potential impact on arterial stiffness, endothelial glycocalyx integrity, and myocardial deformation parameters in the early post-myocardial infarction setting remain limited. The primary aim of the present study is to investigate the effect of empagliflozin administration (10 mg daily) on arterial stiffness, endothelial glycocalyx thickness, and myocardial deformation indices of the left ventricle and left atrium during a 12-month follow-up period in patients presenting with ST-segment elevation myocardial infarction (STEMI). Secondary objectives include:

1. 1.evaluation of the incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, recurrent myocardial infarction, and acute ischemic stroke;
2. 2.investigation of the association between the occurrence of MACE and vascular and myocardial functional parameters, including indices of arterial stiffness, endothelial glycocalyx integrity, and myocardial strain measurements; and
3. 3.assessment of oxidative stress burden through circulating biomarkers. This prospective observational study will include adult patients diagnosed with acute STEMI who are hospitalized in the Second University Cardiology Clinic of "Attikon" General Hospital. All participants will provide written informed consent prior to enrollment and will receive standard guideline-directed therapy for acute myocardial infarction according to the current European Society of Cardiology (ESC) guidelines.

Conditions

Myocardial Infarction (MI); Diabete Type 2

Keywords

arterial stiffness; sglt2i; myocardial deformation; endothelial glycocalyx

Outcome Measures

Primary Outcomes (4)

• Comparison of endothelial glycocalyx thickness difference between groups

  Comparison of Perfused Boundary Region (PBR) difference of sublingual vessels between groups

  12 months

• Comparison of arterial stiffness difference between groups

  Comparison of carotid-to-femoral Pulse Wave Velocity (PWV) difference between groups

  12 months

• Comparison of left atrial deformation difference between groups

  Comparison of left atrial strain difference between groups

  12 months

• Comparison of left ventricular deformation difference between groups

  Comparison of left ventricular strain difference between groups

  12 months

Secondary Outcomes (2)

• Comparison of oxidative stress burden difference between groups

  12 monnths

• Comparison of major adverse cardiovascular events between groups

  12 months

Study Arms (2)

Group A: Empagliflozin group

Group A: STEMI Patients initiated on empagliflozin 10 mg once daily, initiated either at hospital discharge due to the presence of type 2 diabetes mellitus, or without diabetes who exhibit reduced left ventricular ejection fraction (LVEF \<40%). All participants (n≥40) will undergo assessment of arterial stiffness by measing PWV, evaluation of thickness of endothelial glycocalyx bymeasuring PBR, assessment of myocardial deformation by measuring LA strain and LV GLS and quantification of oxidative stress burden by measuring MDa and PCs at baseline, at 3, 6 months and at 12 months.

Group B: Control group

Group B: STEMI patients not initiated on empagliflozin 10 mg once daily. All participants (n≥40) will undergo assessment of arterial stiffness by measing PWV, evaluation of thickness of endothelial glycocalyx by measuring PBR, assessment of myocardial deformation by measuring LA strain and LV GLS and quantification of oxidative stress burden by measuring MDa and PCs at baseline, at 3, 6 months and at 12 months.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective observational study will include adult patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) who are hospitalized at the Second University Cardiology Clinic of "Attikon" General Hospital. Prior to participation, all individuals will provide written informed consent in accordance with the principles outlined in the Declaration of Helsinki. A comprehensive clinical assessment will be performed for all participants, including detailed medical history, physical examination, and laboratory evaluation. Participants will be allocated into two study groups: Group A: Patients receiving empagliflozin 10 mg once daily, initiated either at hospital discharge due to the presence of type 2 diabetes mellitus, or without diabetes who exhibit reduced left ventricular ejection fraction (LVEF \<40%). Group B (Control Group): Patients who will not receive empagliflozin therapy.

You may qualify if:

• STEMI participants with type 2 diabetes or LVEF\<40%

You may not qualify if:

• Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m²
• Active malignancy
• Autoimmune or autoinflammatory disorders
• Severe hepatic impairment
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Attikon University Hospital, 2nd Department of Cardiology, National and Kapodistrina University of Athens

Athens, Rimini1/Haidari, 12462, Greece

RECRUITING

Related Links

• Cardiometabolic outcomes with dapagliflozin after myocardial infarction by baseline ejection fraction: DAPA-MI
• Empagliflozin after Acute Myocardial Infarction
• Novel Drug Targets in Diastolic Heart Disease
• https://pubmed.ncbi.nlm.nih.gov/40535333/
• Effects of dapagliflozin on cardiac function and short-term prognosis of patients with both acute myocardial infarction and type 2 diabetes mellitus
• Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging

MeSH Terms

Conditions

Myocardial Infarction; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Ignatios Ikonomidis, MD;PhD

CONTACT

0030 6944805732; ignoik@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor of Cardiology

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): August 14, 2028
• Study Completion (Estimated): December 20, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

GR (1)