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Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Adults With Newly Diagnosed Hypertension (HYPER-endoEV-a)

2026年7月22日 更新者：Ines Drenjancevic、Josip Juraj Strossmayer University of Osijek

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

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 克罗地亚
      • Osijek、克罗地亚、31000
        • 招聘中
        • Faculty of Medicine Osijek
        • 接触：
        • 接触：
        • 首席研究员：
          • Ivana Tolj, MD, PhD
        • 副研究员：
          • Marko Stupin, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Normotensive Controls
Adults aged 18 years or older with normal office blood pressure according to the European Society of Hypertension (ESH) guidelines and without a history of hypertension or antihypertensive treatment.
Adults With Newly Diagnosed Untreated Primary Hypertension
Adults aged 18 years or older with newly diagnosed, previously untreated primary hypertension according to the European Society of Hypertension (ESH) guidelines and no prior use of antihypertensive medication.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Plasma endothelial extracellular vesicle concentration
大体时间：Baseline
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
Baseline

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Josip Juraj Strossmayer University of Osijek

合作者

Osijek University Hospital

调查人员

  • 学习椅：Ana Stupin, MD, PhD、Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2029年4月30日

研究完成 (估计的)

2029年9月30日

研究注册日期

首次提交

2026年7月22日

首先提交符合 QC 标准的

2026年7月22日

首次发布 (实际的)

2026年7月27日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HYPER-endoEV-adults

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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