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临床试验/NCT06316271
NCT06316271尚未招募不适用

Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension

Josip Juraj Strossmayer University of Osijek1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Aortic stiffness

研究概览

简要总结

In the frame of this proposal investigators will test the hypothesis that high normal blood pressure (prehypertension; PreHT) induces systemic endothelial dysfunction and endothelial activation in both micro- and macrocirculation, reduces re-endothelialization potential of human endothelial progenitor cells (EPCs) and increases the level of endothelial extracellular vesicles (EVs), which are accompanied by increased oxidative stress level. Furthermore, initial vascular and left ventricle (LV) remodeling contributes to changes in systemic hemodynamics and may be influenced by altered regulatory role of renin-angiotensin system (RAS) and autonomic nervous system (ANS) in PreHT but otherwise healthy individuals. To distinguish high normal blood pressure effect from those considered normal or high, study will be performed in three groups of individuals: prehypertensive (BP 130-139/85-89 mmHg), hypertensive (stage I, BP 140-150/90-100 mmHg), and controls (BP less than or equal to 129/85 mmHg). Altogether, the impairment of normal vascular relaxation mechanisms, endothelial activation as well as vascular and LV remodeling could play crucial role in increased cardiovascular risk and CVDs incidence in PreHT individuals. Moreover, the prognostic significance of assessing endotehlial dysfunction in hypertension (as well as in PreHT) is yet to be established.

研究设计

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

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults of both sexes with normotensive, prehypertensive and grade I hypertension blood pressure values

排除标准

  • cardiovascular diseases, but grade I hypertension (BP 140-150/90-100 mmHg)
  • kidney disease
  • cerebrovascular diseases
  • peripheral artery disease
  • taking oral contraceptives or any drugs that could affect the endothelium

结局指标

主要结局

Aortic stiffness

时间窗: Day 1

Measurement of pulse wave velocity (PWV) using impedance cardiography.

Left ventricle global longitudinal strain

时间窗: Day 1

Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.

Systemic microvascular function

时间窗: Day 1

Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside, local thermal hyperemia) - measured in perfusion units (PU)

Systemic macrovascular function

时间窗: Day 1

Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)

次要结局

  • Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α)(Day 1)
  • Endothelial extracellular vesicles (eEVs)(Day 1)
  • Systemic peripheral vascular resistance(Day 1)
  • Matrix metalloproteinase 9(Day 1)
  • Autonomic nervous system (ANS) activity(Day 1)
  • Activity of renin-angiotensin system (RAS)(Day 1)
  • Endothelial progenitor cells (EPCs)(Day 1)

研究者

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

Ines Drenjancevic

Vice Dean for Science Faculty of Medicine Osijek

Josip Juraj Strossmayer University of Osijek

研究点 (1)

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