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Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Children With Newly Diagnosed Hypertension

Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Children With Newly Diagnosed Untreated Primary Hypertension

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07728643
Acronym
HYPER-endoEV-c
Enrollment
80
Registered
2026-07-27
Start date
2026-04-01
Completion date
2029-09-30
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Pediatric Hypertension, Primary Hypertension

Keywords

Pediatric Hypertension, Childhood Hypertension, Primary Hypertension, Endothelial Extracellular Vesicles, Endothelial Dysfunction, Endothelial Activation, Biomarkers, Microvascular Function, Laser Doppler Flowmetry, Cardiovascular Risk

Brief 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.

Interventions

None listed

Sponsors

Josip Juraj Strossmayer University of Osijek
Lead SponsorOTHER
Osijek University Hospital
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma endothelial extracellular vesicle concentrationBaselineConcentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.

Secondary

MeasureTime frameDescription
Post-occlusive reactive hyperemia (PORH)BaselineMicrovascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.
Acetylcholine-induced vasodilation (AChID)BaselineEndothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.
Sodium nitroprusside-induced vasodilation (SNPID)BaselineEndothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.
VCAM-1 concentrationBaselinePlasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.
ICAM-1 concentrationBaselinePlasma intercellular adhesion molecule-1 (ICAM-1) concentration measured as a marker of endothelial activation.
Endocan concentrationBaselinePlasma endocan concentration measured as a marker of endothelial dysfunction.
von Willebrand factor (vWF)BaselinePlasma von Willebrand factor concentration measured as a marker of endothelial injury.
Matrix metalloproteinase-9 (MMP-9)BaselinePlasma MMP-9 concentration measured as a marker of vascular remodeling and endothelial dysfunction.

Countries

Croatia

Contacts

CONTACTIvana Jukić, MD, PhD
medicina@mefos.hr+38531512800
CONTACTAna Stupin, MD, PhD
medicina@mefos.hr+38531512800
STUDY_CHAIRIvana Jukić, MD, PhD

Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026