About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Secondary hypertension.
Previous treatment with antihypertensive medication.
History of cardiovascular disease (except newly diagnosed primary hypertension in the hypertensive group).
Diabetes mellitus.
Trial population
The study population will consist of adult men and women aged 18 years and older recruited from the outpatient clinics of the University Hospital Centre Osijek, Croatia. The study will include normotensive individuals and patients with newly diagnosed, previously untreated primary hypertension. Healthy volunteers will serve as the control group.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Plasma endothelial extracellular vesicle concentration
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
Secondary outcomes
PORH response (R-O%)
Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.
Acetylcholine-induced vasodilation (AChID)
Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.
Sodium nitroprusside-induced vasodilation (SNPID)
Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.
VCAM-1 concentration
Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.
Sponsors and contacts
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Josip Juraj Strossmayer University of Osijek
Lead sponsor
Osijek University Hospital
Collaborator