Child, OnlyNCT05109013
Juvenile Essential Arterial Hypertension and Vascular Function
An observational study of Child, Only and Essential Hypertension, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Essential Hypertension
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children aged 9-18 years of both sexes; normotensive and children with essential arterial hypertension
Who may be able to join
- healthy normotensive children and children with essential arterial hypertension
Who cannot join
- 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..).
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Osijek University Hospital
Osijek, 31000
Martina Kos, MD, +385981748381, mkatic983@gmail.com
About this study
Official title: Juvenile Essential Arterial Hypertension and Vascular Reactivity in Systemic and Cerebral Circulation
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.
- Conditions
- Child, Only, Essential Hypertension
- Keywords
- cerebral circulation, child, endothelium, microcirculation, macrocirculation, hypertension, oxidative stress
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NT group - normotensive children | Not described | |
| HT group - hypertensive children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1.
Systemic macrovascular function in children
Vascular ultrasound measurement of brachial artery response to vascular occlusion (flow mediated dilation; FMD, %)
Measured: Day 1.
Cerabral vascular function in children
Cerebral blood flow velocities assessed by transcranial Doppler sonography (cm/s)
Measured: Day 1.
Secondary outcomes (2)
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.
Measured: Day 1.
Endocan
Serum sample collection for ELISA measurement of serum endocan level - proteoglycan associated with endothelium activation
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
- Investigators
- Martina Kos, MD, Principal investigator, Osijek University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109013
- Sponsor's protocol ID
- 2158-61-07-21-06
- Status last verified
- Nov 2021
- First submitted
- 2 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Juvenile Essential Arterial Hypertension and Vascular Reactivity in Systemic and Cerebral Circulation
- ClinicalTrials.gov ID
- NCT05109013
- Acronym / sponsor ID
- 2158-61-07-21-06
- Conditions
- Child, Only, Essential Hypertension
- Keywords
- cerebral circulation, child, endothelium, microcirculation, macrocirculation, hypertension, oxidative stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT group - normotensive children | – | – |
| HT group - hypertensive children | – | – |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children aged 9-18 years of both sexes; normotensive and children with essential arterial hypertension
Key inclusion criteria (1 listed)
- healthy normotensive children and children with essential arterial hypertension
Key exclusion criteria (4 listed)
- 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..).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic microvascular function in children
Time frame: 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
Time frame: Day 1.
Vascular ultrasound measurement of brachial artery response to vascular occlusion (flow mediated dilation; FMD, %)
Cerabral vascular function in children
Time frame: Day 1.
Cerebral blood flow velocities assessed by transcranial Doppler sonography (cm/s)
2 secondary outcomes
Oxidative stress - thiobarbituric acid reactive substances (TBARS)
Time frame: Day 1.
Endocan
Time frame: Day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Kos, MD principal investigator
Osijek University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child, Only and Essential Hypertension, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Kos, MD (+385981748381, mkatic983@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic microvascular function in children (time frame: Day 1.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.