protocolSection identificationModule nctId: NCT06316271, orgStudyIdInfo id: PreHT 2024, briefTitle: Endothelial Function in Prehypertension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Josip Juraj Strossmayer University of Osijek, class: OTHER, collaborators name: University Hospital Center Osijek, descriptionModule briefSummary: 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., conditionsModule conditions: Hypertension,Essential, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Systemic microvascular function, primaryOutcomes measure: Systemic macrovascular function, primaryOutcomes measure: Aortic stiffness, primaryOutcomes measure: Left ventricle global longitudinal strain, secondaryOutcomes measure: Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α), secondaryOutcomes measure: Activity of renin-angiotensin system (RAS), secondaryOutcomes measure: Endothelial progenitor cells (EPCs), secondaryOutcomes measure: Endothelial extracellular vesicles (eEVs), secondaryOutcomes measure: Systemic peripheral vascular resistance, secondaryOutcomes measure: Autonomic nervous system (ANS) activity, secondaryOutcomes measure: Matrix metalloproteinase 9, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine Osijek, city: Osijek, zip: 31000, country: Croatia, geoPoint lat: 45.55111, lon: 18.69389, hasResults: False