Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Adults With Newly Diagnosed Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertension, Endothelial Function. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Adults With Newly Diagnosed Untreated Hypertension
Overview
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.
Primary outcome measures
- Plasma endothelial extracellular vesicle concentration [Time frame: Baseline]
Secondary outcome measures (7)
- PORH response (R-O%) [Time frame: Baseline]
- Acetylcholine-induced vasodilation (AChID) [Time frame: Baseline]
- Sodium nitroprusside-induced vasodilation (SNPID) [Time frame: Baseline]
- VCAM-1 concentration [Time frame: Baseline]
- ICAM-1 concentration [Time frame: Baseline]
- Endocan concentration [Time frame: Baseline]
- Matrix metalloproteinase-9 (MMP-9) [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Croatia · 1 center
- Faculty of Medicine Osijek — Osijek
Identifiers
NCT: NCT07728630 · HYPER-endoEV-adults