Arterial HypertensionNCT03674918
Reliable Hypertension Diagnosis Based on 24 ABPM
An observational study of Arterial Hypertension, run by Hasselt University at 1 site in Belgium.
Trial summary
24 h blood pressure monitoring can help to define which is the optimal timing and frequency of measurements Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- 24 h ambulatory blood pressure measurements
- How many people
- 408 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2015to 1 Jul 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Arterial hypertension, HBPM, 24h ABPM, optimal diagnosis
Who may be able to join
- 70 per cent of valid measurements
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Arterial Hypertension
- Being tested
- 24 h ambulatory blood pressure measurements
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 h ambulatory blood pressure measurementsDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 24 h ambulatory blood pressure measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (1)
The correct number of measurements
Within the intervals, the correct number of measurements needed to diagnose hypertension will be evaluated.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Jul 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies 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
- Retrospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
- Investigators
- Caro Brenard, student, Study chair, University of LeuvenVincent Raymaekers, student, Study chair, Universiteit AntwerpenPaul Dendale, prof. dr., Principal investigator, Hasselt UniversityInes Frederix, dr. MD, Study director, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674918
- Sponsor's protocol ID
- 24 ABPM001
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Reliably Diagnose Arterial Hypertension: Lessons From 24h Blood Pressure Monitoring.
- ClinicalTrials.gov ID
- NCT03674918
- Acronym / sponsor ID
- 24 ABPM001
- Conditions
- Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 18 Sep 2018 (actual)
- 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.
24 h blood pressure monitoring can help to define which is the optimal timing and frequency of 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| persons with arterial hypertension | – | Diagnostic Test: 24 h ambulatory blood pressure measurementspatients referred to consultation cardiology for hypertension. They get a 24 h blood pressure monitoring to define the exact mean arterial blood pressure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Arterial hypertension, HBPM, 24h ABPM, optimal diagnosis
Key inclusion criteria (1 listed)
- 70 per cent of valid measurements
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 h ambulatory blood pressure measurements24 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 | Diagnostic test | persons with arterial hypertension |
Primary outcome
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.
1 secondary outcome
The correct number of measurements
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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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.
Caro Brenard, student study chair
University of Leuven
Vincent Raymaekers, student study chair
Universiteit Antwerpen
Paul Dendale, prof. dr. principal investigator
Hasselt University
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 Arterial Hypertension, run by Hasselt University at 1 site in Belgium.
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: finished, as of the sponsor's last update on 18 Sep 2018. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of measurement (time frame: day 1). 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 18 Sep 2018; AzTrials last refreshed its copy on 31 Oct 2026.