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Reliable Hypertension Diagnosis Based on 24 ABPM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674918
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Jessa Hospital
Information provided by (Responsible Party):
prof. dr. Paul Dendale, Hasselt University

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

Condition or disease Intervention/treatment
Arterial Hypertension Diagnostic Test: 24 h ambulatory blood pressure measurements

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.

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Study Type : Observational
Actual Enrollment : 408 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: How to Reliably Diagnose Arterial Hypertension: Lessons From 24h Blood Pressure Monitoring.
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The correct number of measurements [ Time Frame: day 1 ]
    Within the intervals, the correct number of measurements needed to diagnose hypertension will be evaluated.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Arterial hypertension, HBPM, 24h ABPM, optimal diagnosis
Criteria

Inclusion Criteria:

  • 70 per cent of valid measurements

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674918


Locations
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Belgium
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Sponsors and Collaborators
Hasselt University
Jessa Hospital
Investigators
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Study Chair: Caro Brenard, student University of Leuven
Study Chair: Vincent Raymaekers, student Universiteit Antwerpen
Principal Investigator: Paul Dendale, prof. dr. Hasselt University
Study Director: Ines Frederix, dr. MD Hasselt University
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Responsible Party: prof. dr. Paul Dendale, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03674918    
Other Study ID Numbers: 24 ABPM001
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases