HealthyNCT02222077
Central Blood Pressure in Adolescents and Young Adults
An observational study of Healthy and Hypertension, run by University of Athens at 1 site in Greece.
Trial summary
This study aims to investigate in adolescents and young adults: the 24h diurnal variation of ambulatory central blood pressure the association of central compared to peripheral blood pressure with indices of asymptomatic target-organ damage Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hypertension
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2014to Feb 2018
- 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 12 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy volunteers and subjects referred to the Hypertension Clinic for the assessment of elevated blood pressure
Who may be able to join
- Adolescents and young adults (age range 12-25 years)
Who cannot join
- Subjects with any acute or significant chronic disease, with evidence of secondary hypertension, or on regular drug treatment will be excluded
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hypertension Center, 3rd University Department of Medicine, Sotiria Hospital
Athens, Attica, 11527
George S Stergiou, Professor of Medicine, +302107763117, gstergi@med.uoa.gr
About this study
Official title: Diurnal Variation of Central Blood Pressure in Adolescents and Young Adults and Association With Indices of Asymptomatic Target-organ Damage
This study aims to investigate in adolescents and young adults:
- the 24h diurnal variation of ambulatory central blood pressure
- the association of central compared to peripheral blood pressure with indices of asymptomatic target-organ damage
- Conditions
- Healthy, Hypertension
- Keywords
- Central blood pressure, Ambulatory blood pressure monitoring, Target-organ damage, Adolescents and young adults
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficients (r) between 24h ambulatory central blood pressure and indices of target-organ damage
Correlation coefficients (r) will be determined for the relationship between central blood pressure and indices of target-organ damage (left ventricular mass index, carotid intima-media thickness, pulse wave velocity). Also, these coefficients will be compared with z-statistic with the respective ones for the peripheral blood pressure.
Measured: Assessment of each individual will require up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George S. Stergiou, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222077
- Sponsor's protocol ID
- Central BP-TOD
- Status last verified
- Sep 2017
- First submitted
- 15 Aug 2014
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Variation of Central Blood Pressure in Adolescents and Young Adults and Association With Indices of Asymptomatic Target-organ Damage
- ClinicalTrials.gov ID
- NCT02222077
- Acronym / sponsor ID
- Central BP-TOD
- Conditions
- Healthy, Hypertension
- Keywords
- Central blood pressure, Ambulatory blood pressure monitoring, Target-organ damage, Adolescents and young adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 21 Aug 2014 (estimated)
- 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.
This study aims to investigate in adolescents and young adults:
- the 24h diurnal variation of ambulatory central blood pressure
- the association of central compared to peripheral blood pressure with indices of asymptomatic target-organ damage
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy volunteers and subjects referred to the Hypertension Clinic for the assessment of elevated blood pressure
Key inclusion criteria (1 listed)
- Adolescents and young adults (age range 12-25 years)
Key exclusion criteria (1 listed)
- Subjects with any acute or significant chronic disease, with evidence of secondary hypertension, or on regular drug treatment will be excluded
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
Correlation coefficients (r) between 24h ambulatory central blood pressure and indices of target-organ damage
Time frame: Assessment of each individual will require up to 3 days
Correlation coefficients (r) will be determined for the relationship between central blood pressure and indices of target-organ damage (left ventricular mass index, carotid intima-media thickness, pulse wave velocity). Also, these coefficients will be compared with z-statistic with the respective ones for the peripheral blood pressure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
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 Healthy and Hypertension, run by University of Athens at 1 site in Greece.
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 1 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 14 Sep 2017. 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 Greece. 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 George S Stergiou, Professor of Medicine (+302107763117, gstergi@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficients (r) between 24h ambulatory central blood pressure and indices of target-organ damage (time frame: Assessment of each individual will require up to 3 days). 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 14 Sep 2017.