Endothelial Function in Prehypertension
- Conditions
- Hypertension,Essential
- Registration Number
- NCT06316271
- Lead Sponsor
- Josip Juraj Strossmayer University of Osijek
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- adults of both sexes with normotensive, prehypertensive and grade I hypertension blood pressure values
- cardiovascular diseases, but grade I hypertension (BP 140-150/90-100 mmHg)
- diabetes
- kidney disease
- cerebrovascular diseases
- peripheral artery disease
- taking oral contraceptives or any drugs that could affect the endothelium
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Aortic stiffness Day 1 Measurement of pulse wave velocity (PWV) using impedance cardiography.
Left ventricle global longitudinal strain Day 1 Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.
Systemic microvascular function 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 Day 1 Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
- Secondary Outcome Measures
Name Time Method Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α) 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.
Endothelial extracellular vesicles (eEVs) Day 1 Detection of eEVs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Systemic peripheral vascular resistance Day 1 Systemic peripheral vascular resistance assessement using non-invasive impedance cardiography (ICG).
Matrix metalloproteinase 9 Day 1 ELISA measurement of serum matrix metalloproteinase 9 level.
Autonomic nervous system (ANS) activity Day 1 Assessment of a 5-minute heart rate variability (5-min HRV).
Activity of renin-angiotensin system (RAS) Day 1 ELISA measurement of plasma renin activity (PRA).
Endothelial progenitor cells (EPCs) Day 1 Detection of EPCs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Trial Locations
- Locations (1)
Faculty of Medicine Osijek
🇭🇷Osijek, Croatia