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临床试验/NCT07728630
NCT07728630招募中不适用

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

Josip Juraj Strossmayer University of Osijek1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Plasma endothelial extracellular vesicle concentration

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Plasma endothelial extracellular vesicle concentration

时间窗: Baseline

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

次要结局

  • PORH response (R-O%)(Baseline)
  • Acetylcholine-induced vasodilation (AChID)(Baseline)
  • Sodium nitroprusside-induced vasodilation (SNPID)(Baseline)
  • VCAM-1 concentration(Baseline)
  • ICAM-1 concentration(Baseline)
  • Endocan concentration(Baseline)
  • Matrix metalloproteinase-9 (MMP-9)(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ines Drenjancevic

Full Professore Tenure, Head of Department of Physiology and Immunology, Faculty of Medicine Osijek

Josip Juraj Strossmayer University of Osijek

研究点 (1)

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