Endothelial Function in Prehypertension

Hypertension,Essential Clinical Trial

Official title:

Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06316271
• Other study ID #: PreHT 2024
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential
• Prehypertension

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