NCT03674918

Brief Summary

24 h blood pressure monitoring can help to define which is the optimal timing and frequency of measurements

Trial Health

87
On Track

Trial Health Score

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

Enrollment
408

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

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, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 14, 2018

Last Update Submit

September 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Timing of measurement

    9:00-13:00 - 13:00-17:00 - 17:00 - 21:00: there intervals were analyzed to assess the predictive value of each interval compared with the overall daytime diagnosis of hypertension.

    day 1

Secondary Outcomes (1)

  • The correct number of measurements

    day 1

Study Arms (1)

persons with arterial hypertension

patients referred to consultation cardiology for hypertension. They get a 24 h blood pressure monitoring to define the exact mean arterial blood pressure

Diagnostic Test: 24 h ambulatory blood pressure measurements

Interventions

24 h ambulatory blood pressure measurements : an ambulatory 24 h blood pressure device that automatically measures blood pressure every 15 minutes is given to the patient for 24 h

persons with arterial hypertension

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Arterial hypertension, HBPM, 24h ABPM, optimal diagnosis

You may qualify if:

  • per cent of valid measurements

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Caro Brenard, student

    University of Leuven

    STUDY CHAIR
  • Vincent Raymaekers, student

    Universiteit Antwerpen

    STUDY CHAIR
  • Paul Dendale, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR
  • Ines Frederix, dr. MD

    Hasselt University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 18, 2018

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations