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NCT Number: NCT07728643

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

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.

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Key information

Conditions

Pediatric Hypertension Cardiovascular Diseases Endothelial Dysfunction Essential Hypertension Hypertension Primary Hypertension Vascular Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Osijek

Osijek, 31000, Croatia

Location status: Recruiting

Location contact

Mia Damašek, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Plasma endothelial extracellular vesicle concentration

    Time frame: Baseline

    Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.

Secondary outcomes

  1. Post-occlusive reactive hyperemia (PORH)

    Time frame: Baseline

    Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.

  2. Acetylcholine-induced vasodilation (AChID)

    Time frame: Baseline

    Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.

  3. Sodium nitroprusside-induced vasodilation (SNPID)

    Time frame: Baseline

    Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.

  4. VCAM-1 concentration

    Time frame: Baseline

    Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.

  5. ICAM-1 concentration

    Time frame: Baseline

    Plasma intercellular adhesion molecule-1 (ICAM-1) concentration measured as a marker of endothelial activation.

  6. Endocan concentration

    Time frame: Baseline

    Plasma endocan concentration measured as a marker of endothelial dysfunction.

  7. von Willebrand factor (vWF)

    Time frame: Baseline

    Plasma von Willebrand factor concentration measured as a marker of endothelial injury.

  8. Matrix metalloproteinase-9 (MMP-9)

    Time frame: Baseline

    Plasma MMP-9 concentration measured as a marker of vascular remodeling and endothelial dysfunction.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Stupin, MD, PhD

CONTACT

[email protected]

+38531512800

Ivana Jukić, MD, PhD

CONTACT

[email protected]

+38531512800

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • Osijek University Hospital

Registry information

Official study title

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

Acronym: HYPER-endoEV-c

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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