Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Children With Newly Diagnosed Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pediatric Hypertension, Primary Hypertension, Endothelial Dysfunction. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Children With Newly Diagnosed Untreated Primary Hypertension
Overview
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.
Primary outcome measures
- Plasma endothelial extracellular vesicle concentration [Time frame: Baseline]
Secondary outcome measures (8)
- Post-occlusive reactive hyperemia (PORH) [Time frame: Baseline]
- Acetylcholine-induced vasodilation (AChID) [Time frame: Baseline]
- Sodium nitroprusside-induced vasodilation (SNPID) [Time frame: Baseline]
- VCAM-1 concentration [Time frame: Baseline]
- ICAM-1 concentration [Time frame: Baseline]
- Endocan concentration [Time frame: Baseline]
- von Willebrand factor (vWF) [Time frame: Baseline]
- Matrix metalloproteinase-9 (MMP-9) [Time frame: Baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Croatia · 1 center
- Faculty of Medicine Osijek — Osijek
Identifiers
NCT: NCT07728643 · HYPER-endoEV-children