Juvenile Essential Arterial Hypertension and Vascular Function

Sponsor

Josip Juraj Strossmayer University of Osijek (Other)

Overall Status

Recruiting

CT.gov ID

NCT05109013

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Child, Only Essential Hypertension

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
NT group - normotensive children
HT group - hypertensive children

Outcome Measures

Primary Outcome Measures

Systemic microvascular function in children [Day 1.]
Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside) - measured in perfusion units (PU)
Systemic macrovascular function in children [Day 1.]
Vascular ultrasound measurement of brachial artery response to vascular occlusion (flow mediated dilation; FMD, %)
Cerabral vascular function in children [Day 1.]
Cerebral blood flow velocities assessed by transcranial Doppler sonography (cm/s)

Secondary Outcome Measures

Oxidative stress - thiobarbituric acid reactive substances (TBARS) [Day 1.]
Serum sample collection for measurement of biomarkers of oxidative stress level. Thiobarbituric acid reactive substances (TBARS) - biomarker of lipid peroxidation.
Endocan [Day 1.]
Serum sample collection for ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation

Other Outcome Measures

Blood pressure [Day 1.]
Automatic oscillometric measurement of blood pressure (in mmHg)
Heart rate [Day 1.]
Automatic oscillometric measurement of heart rate (bpm)
Body mass index [Day 1.]
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)
Body composition - Fat Free Mass estimation [Day 1.]
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)
Body composition - Fat estimation [Day 1.]
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)
Body fluid status [Day 1.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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..).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osijek University Hospital	Osijek		Croatia	31000

Sponsors and Collaborators

Josip Juraj Strossmayer University of Osijek

Investigators

Principal Investigator: Martina Kos, MD, Osijek University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ines Drenjancevic, Head of Department of Physiology and Immunology Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek

ClinicalTrials.gov Identifier:

NCT05109013

Other Study ID Numbers:

2158-61-07-21-06

First Posted:

Nov 5, 2021

Last Update Posted:

Nov 11, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ines Drenjancevic, Head of Department of Physiology and Immunology Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek

Additional relevant MeSH terms:

Hypertension

Essential Hypertension

Study Results

No Results Posted as of Nov 11, 2021