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NCT07728643
Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Children With Newly Diagnosed Hypertension
Conditions: Pediatric Hypertension, Primary Hypertension, Endothelial Dysfunction
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: Yes
Enrollment: 80
Sponsor: Josip Juraj Strossmayer University of Osijek
Location: Faculty of Medicine Osijek Osijek
Summary
Childhood hypertension is associated with early endothelial dysfunction and an increased risk of future cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their role in pediatric hypertension remains poorly understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive children and children with newly diagnosed, untreated primary hypertension. The study will also investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and circulating biomarkers of endothelial activation. The findings may improve understanding of endothelial injury in pediatric hypertension and support the development of non-invasive biomarkers for early cardiovascular risk assessment.
Eligibility Criteria
Inclusion Criteria:
* Children and adolescents aged 6-17 years.
* Written informed consent from a parent or legal guardian and assent from the participant when appropriate.
* Normotensive status or newly diagnosed, previously untreated primary hypertension according to current pediatric hypertension guidelines.
* Ability to comply with study procedures.
Exclusion Criteria:
* Secondary hypertension.
* Previous antihypertensive treatment.
* Congenital heart disease or other significant cardiovascular disease.
* Diabetes mellitus.
* Chronic kidney disease.
* Autoimmune or chronic inflammatory disease.
* Acute infection at the time of enrollment.
* Malignancy.
* Use of medications known to affect endothelial function.
* Inability to comply with study procedures.
Source: ClinicalTrials.gov (NCT07728643). StuddyBuddy aggregates publicly available trial information.