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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07728630

Acronym

HYPER-endoEV-a

Enrollment

Registered

2026-07-27

Start date

2026-05-01

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 Function, Hypertension

Keywords

Hypertension, Primary Hypertension, Endothelial Dysfunction, Endothelial Extracellular Vesicles, Extracellular Vesicles, Endothelial Activation, Biomarkers, Microvascular Function, Laser Doppler Flowmetry, Post-Occlusive Reactive Hyperemia, Vascular Function

Brief summary

Hypertension is associated with endothelial dysfunction, an early event in the development of cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation and vascular injury; however, their relationship with blood pressure and microvascular endothelial function in untreated hypertension remains insufficiently understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive adults and adults with newly diagnosed, untreated primary hypertension. In addition, the study will investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and established circulating biomarkers of endothelial activation. The findings may improve understanding of the role of EEVs in early hypertension and support their potential use as non-invasive biomarkers of endothelial dysfunction and cardiovascular risk.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Adults aged 18 years or older. * Ability and willingness to provide written informed consent. * Normotensive individuals or individuals with newly diagnosed, previously untreated primary hypertension, classified according to the European Society of Hypertension (ESH) guidelines. * Ability to comply with all study procedures.

Exclusion criteria

* Secondary hypertension. * Previous treatment with antihypertensive medication. * History of cardiovascular disease (except newly diagnosed primary hypertension in the hypertensive group). * Diabetes mellitus. * Chronic kidney disease. * Cerebrovascular disease. * Peripheral arterial disease. * Acute or chronic inflammatory or infectious disease. * Active malignancy. * Pregnancy or breastfeeding. * Current use of oral contraceptives, hormone replacement therapy, or medications known to affect endothelial function. * Inability or unwillingness to provide informed consent.

Design outcomes

Primary

Measure	Time frame	Description
Plasma endothelial extracellular vesicle concentration	Baseline	Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.

Secondary

Measure	Time frame	Description
PORH response (R-O%)	Baseline	Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.
Acetylcholine-induced vasodilation (AChID)	Baseline	Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.
Sodium nitroprusside-induced vasodilation (SNPID)	Baseline	Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.
VCAM-1 concentration	Baseline	Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.
ICAM-1 concentration	Baseline	Plasma intercellular adhesion molecule-1 (ICAM-1) concentration measured as a marker of endothelial activation.
Endocan concentration	Baseline	Plasma endocan concentration measured as a marker of endothelial dysfunction.
Matrix metalloproteinase-9 (MMP-9)	Baseline	Plasma MMP-9 concentration measured as a marker of vascular remodeling and endothelial dysfunction.

Countries

Croatia

Contacts

CONTACTAna Stupin, MD, PhD

ana.stupin@mefos.hr+38531512800

CONTACTIvana Jukić, MD, PhD

ivana.jukic@mefos.hr

STUDY_CHAIRAna Stupin, MD, PhD

Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

Outcome results