Faculty of Medicine Osijek
Osijek, 31000, Croatia
NCT Number: NCT06316271
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.
Trial opening soon.
Get Notified18 year–69 year
All sexes
Observational
Osijek, 31000, Croatia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Day 1
Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
Time frame: Day 1
Measurement of pulse wave velocity (PWV) using impedance cardiography.
Time frame: Day 1
Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.
Time frame: Day 1
ELISA measurement of serum 8-iso-PGF2α concentration. 8-iso-PGF2α is an isoprostane that is produced by the non-enzymatic peroxidation of arachidonic acid in membrane phospholipids.
Time frame: Day 1
ELISA measurement of plasma renin activity (PRA).
Time frame: Day 1
Detection of EPCs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Time frame: Day 1
Detection of eEVs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Time frame: Day 1
Systemic peripheral vascular resistance assessement using non-invasive impedance cardiography (ICG).
Time frame: Day 1
Assessment of a 5-minute heart rate variability (5-min HRV).
Time frame: Day 1
ELISA measurement of serum matrix metalloproteinase 9 level.
Contact information is provided by the study sponsor or research team.
Josip Juraj Strossmayer University of Osijek
Other
Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension
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