Juvenile Essential Arterial Hypertension and Vascular Function

Essential Hypertension Clinical Trial

Official title:

Juvenile Essential Arterial Hypertension and Vascular Reactivity in Systemic and Cerebral Circulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109013
• Other study ID #: 2158-61-07-21-06
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Martina Kos, MD
• Phone: +385981748381
• Email: mkatic983[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main goal of this study is to investigate the association of the juvenile essential arterial hypertension with systemic micro- and macrovascular reactivity and cerebral vascular function, and to examine the potential impact of elevated oxidative stress on this associations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• healthy normotensive children and children with essential arterial hypertension

Exclusion Criteria:

• secondary arterial hypertension

• other systemic diseases with immunopathology

• neurodegenerative diseasesat

• children that use therapy which has a high impact on vascular or immunological function (immunotherapy, immunosuppressive therapy, sistemic corticosteroid therapy etc..).

Related Conditions & MeSH terms

• Child, Only
• Essential Hypertension
• Hypertension

Locations

Country	Name	City	State
Croatia	Osijek University Hospital	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood pressure	Automatic oscillometric measurement of blood pressure (in mmHg)	Day 1.
Other	Heart rate	Automatic oscillometric measurement of heart rate (bpm)	Day 1.
Other	Body mass index	Measurement of body weight (kg) and body height (cm) from which will be combined to report body mass index (BMI) using formula: weight (kg) / [height (m)]2 (kg/m2)	Day 1.
Other	Body composition - Fat Free Mass estimation	Body composition status measured by a fourterminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically dervide formulas (the original manufacturer's software) will be used to calculate the estimated Fat Free Mass (FFM kg)	Day 1.
Other	Body composition - Fat estimation	Body composition status measured by a fourterminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically dervide formulas (the original manufacturer's software) will be used to calculate the estimated Fat (Fat Mass kg)	Day 1.
Other	Body fluid status	Body fluid status measurement by a four-terminal portable impedance analyzer. Based on the value of skin resistance (Ohm) empirically derived formulas (the original manufacturer's software) will be used to calculate the estimated Total Body Water (TBW L), Extracellular Water (ECW L), Intracellular Water (ICW L), Plasma Fluid (PF L) and Interstitial Fluid (IF L).	Day 1.
Primary	Systemic microvascular function in children	Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)	Day 1.
Primary	Systemic macrovascular function in children	Vascular ultrasound measurement of brachial artery response to vascular occlusion (flow mediated dilation; FMD, %)	Day 1.
Primary	Cerabral vascular function in children	Cerebral blood flow velocities assessed by transcranial Doppler sonography (cm/s)	Day 1.
Secondary	Oxidative stress - thiobarbituric acid reactive substances (TBARS)	Serum sample collection for measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.	Day 1.
Secondary	Endocan	Serum sample collection for ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation	Day 1.