Reliable Hypertension Diagnosis Based on 24 ABPM

September 14, 2018 updated by: prof. dr. Paul Dendale, Hasselt University

How to Reliably Diagnose Arterial Hypertension: Lessons From 24h Blood Pressure Monitoring.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypertension is a common condition in modern society. As blood pressure fluctuates with time, a single blood pressure measurement is useless to diagnose hypertension. Nevertheless, a questionable not well-defined number of measurements still is often used for this purpose. Diagnosis and therapeutic control of hypertension are therefore suboptimal. This study's objective is to determine the number and timing of measurements needed to give a trustworthy approximation of an individual's average blood pressure. Therefore, 24 h ambulatory blood pressure measurements were retrospectively analyzed.

Study Type

Observational

Enrollment (Actual)

408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Arterial hypertension, HBPM, 24h ABPM, optimal diagnosis

Description

Inclusion Criteria:

  • 70 per cent of valid measurements

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of measurement
Time Frame: day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correct number of measurements
Time Frame: day 1
Within the intervals, the correct number of measurements needed to diagnose hypertension will be evaluated.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Collaborators

Jessa Hospital

Investigators

  • Principal Investigator: Paul Dendale, prof. dr., Hasselt University
  • Study Chair: Caro Brenard, student, University of Leuven
  • Study Chair: Vincent Raymaekers, student, Universiteit Antwerpen
  • Study Director: Ines Frederix, dr. MD, Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 14, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24 ABPM001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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