NCT02222077

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

3.6 years

First QC Date

August 15, 2014

Last Update Submit

September 13, 2017

Conditions

HealthyHypertension

Keywords

Central blood pressureAmbulatory blood pressure monitoringTarget-organ damageAdolescents and young adults

Outcome Measures

Primary Outcomes (1)

  • 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.

    Assessment of each individual will require up to 3 days

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers and subjects referred to the Hypertension Clinic for the assessment of elevated blood pressure

You may qualify if:

  • Adolescents and young adults (age range 12-25 years)

You may not qualify if:

  • Subjects with any acute or significant chronic disease, with evidence of secondary hypertension, or on regular drug treatment will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension Center, 3rd University Department of Medicine, Sotiria Hospital

Athens, Attica, 11527, Greece

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

George S Stergiou, Professor of Medicine

CONTACT

+302107763117gstergi@med.uoa.gr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 21, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

GR(1)