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Clinical Trials/NCT06316271
NCT06316271
Not yet recruiting
Not Applicable

Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension

Josip Juraj Strossmayer University of Osijek1 site in 1 country90 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension,Essential
Sponsor
Josip Juraj Strossmayer University of Osijek
Enrollment
90
Locations
1
Primary Endpoint
Aortic stiffness
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ines Drenjancevic

Vice Dean for Science Faculty of Medicine Osijek

Josip Juraj Strossmayer University of Osijek

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Aortic stiffness

Time Frame: Day 1

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

Left ventricle global longitudinal strain

Time Frame: Day 1

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

Systemic microvascular function

Time Frame: 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

Time Frame: Day 1

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

Secondary Outcomes

  • 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)

Study Sites (1)

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