An observational study in Hypertension,Essential, sponsored by Josip Juraj Strossmayer University of Osijek. Not yet recruiting at 1 site in Croatia. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Josip Juraj Strossmayer University of Osijek · Observational
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.
478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.
This study's planned enrollment of 90 is below the median of 702 across 70 observational studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →Josip Juraj Strossmayer University of Osijek is the lead sponsor of 26 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy subjects will be divided in the three study groups based on BP assessment using ambulatory blood pressure monitoring (ABPM). Hypertensive group will include only newly diagnosed patients who have not taken antihypertensive therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BP less than or equal to 129/84 mmHg
BP 130-139/85-89 mmHg
BP 140-150/90-100 mmHg
Systemic microvascular function
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
Systemic macrovascular function
Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
Time frame: Day 1
Aortic stiffness
Measurement of pulse wave velocity (PWV) using impedance cardiography.
Time frame: Day 1
Left ventricle global longitudinal strain
Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.
Time frame: Day 1
Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α)
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
Activity of renin-angiotensin system (RAS)
ELISA measurement of plasma renin activity (PRA).
Time frame: Day 1
Endothelial progenitor cells (EPCs)
Detection of EPCs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Time frame: Day 1
Endothelial extracellular vesicles (eEVs)
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
Systemic peripheral vascular resistance assessement using non-invasive impedance cardiography (ICG).
Time frame: Day 1
Autonomic nervous system (ANS) activity
Assessment of a 5-minute heart rate variability (5-min HRV).
Time frame: Day 1
Matrix metalloproteinase 9
ELISA measurement of serum matrix metalloproteinase 9 level.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2024; primary completion for Dec 2024, 8 months later.
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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Josip Juraj Strossmayer University of Osijek