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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06316271
Other study ID # PreHT 2024
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2026

Study information

Verified date March 2024
Source Josip Juraj Strossmayer University of Osijek
Contact Ines Drenjancevic, MD, PhD
Phone +38531512800
Email ines.drenjancevic@mefos.hr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date December 31, 2026
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 69 Years
Eligibility 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) - diabetes - kidney disease - cerebrovascular diseases - peripheral artery disease - taking oral contraceptives or any drugs that could affect the endothelium

Study Design


Locations

Country Name City State
Croatia Faculty of Medicine Osijek Osijek

Sponsors (2)

Lead Sponsor Collaborator
Josip Juraj Strossmayer University of Osijek University Hospital Center Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Day 1
Primary Systemic macrovascular function Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD) Day 1
Primary Aortic stiffness Measurement of pulse wave velocity (PWV) using impedance cardiography. Day 1
Primary Left ventricle global longitudinal strain Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography. Day 1
Secondary Oxidative stress - 8-iso-prostaglandin F2a (8-iso-PGF2a) ELISA measurement of serum 8-iso-PGF2a concentration. 8-iso-PGF2a is an isoprostane that is produced by the non-enzymatic peroxidation of arachidonic acid in membrane phospholipids. Day 1
Secondary Activity of renin-angiotensin system (RAS) ELISA measurement of plasma renin activity (PRA). Day 1
Secondary Endothelial progenitor cells (EPCs) Detection of EPCs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays). Day 1
Secondary Endothelial extracellular vesicles (eEVs) Detection of eEVs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays). Day 1
Secondary Systemic peripheral vascular resistance Systemic peripheral vascular resistance assessement using non-invasive impedance cardiography (ICG). Day 1
Secondary Autonomic nervous system (ANS) activity Assessment of a 5-minute heart rate variability (5-min HRV). Day 1
Secondary Matrix metalloproteinase 9 ELISA measurement of serum matrix metalloproteinase 9 level. Day 1
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