Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Children With Newly Diagnosed Untreated Primary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Plasma endothelial extracellular vesicle concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Plasma endothelial extracellular vesicle concentration
时间窗: Baseline
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
次要结局
- ICAM-1 concentration(Baseline)
- Post-occlusive reactive hyperemia (PORH)(Baseline)
- Acetylcholine-induced vasodilation (AChID)(Baseline)
- Sodium nitroprusside-induced vasodilation (SNPID)(Baseline)
- VCAM-1 concentration(Baseline)
- Endocan concentration(Baseline)
- von Willebrand factor (vWF)(Baseline)
- Matrix metalloproteinase-9 (MMP-9)(Baseline)
研究者
Ines Drenjancevic
Full Professor Tenure, Head of the Department of Physiology and Immunology, Faculty of Medicine Osijek
Josip Juraj Strossmayer University of Osijek