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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJosip Juraj Strossmayer University of Osijek

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Normotensive Controls
Group B: Adults With Newly Diagnosed Untreated Primary Hypertension

Trial outcomes

Primary outcomes

1

Plasma endothelial extracellular vesicle concentration

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

Time frame
Baseline

Secondary outcomes

1

PORH response (R-O%)

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

Time frame
Baseline
2

Acetylcholine-induced vasodilation (AChID)

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

Time frame
Baseline
3

Sodium nitroprusside-induced vasodilation (SNPID)

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

Time frame
Baseline
4

VCAM-1 concentration

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Josip Juraj Strossmayer University of Osijek

Lead sponsor

Osijek University Hospital

Collaborator