Essential HypertensionPhase 4NISSEINCT01120990
Hybrid Blood Pressure Monitor Validation
A Phase 4 study testing Blood Pressure Measurement in people with Essential Hypertension, run by University of Athens at 1 site in Greece.
Trial summary
Assessment of the accuracy of a Blood Pressure Measuring Device with a digital display-column, NISSEI DM 3000, according to an adaptation of the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults". Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Blood Pressure Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Jul 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above 25 years of age
- Sinus rhythm
- Informed consent
Who cannot join
- Sustained arrhythmia
- Pregnancy
- Poor quality Korotkoff sounds
- Unavailable cuff size
- Completed blood pressure range (according to protocol)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens
About this study
Official title: Validation of a Hybrid Blood Pressure Monitor to Replace the Mercury Standard for Validation Studies According to Modified Criteria of the European Society of Hypertension International Protocol 2010
Assessment of the accuracy of a Blood Pressure Measuring Device with a digital display-column, NISSEI DM 3000, according to an adaptation of the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults".
Read the detailed description
According to the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults", 33 patients have their blood pressure measured by two observers using parallel connected mercury sphygmomanometers, blinded from each other's result, and then by the supervisor using the tested device, NISSEI DM 3000. The measurements using the mercury sphygmomanometers are repeated 5 times and in between them, 4 measurements using the tested device take place. If the results of the comparison of these measurements according to the analysis required by the protocol, meet the required criteria, the device is regarded as "Pass", otherwise as "Fail".
In this study, instead of consecutive, simultaneous measurements of the two mercury sphygmomanometers and tha tested device will be taking place. This will be so to exclude any inaccuracy due to blood pressure variability and because the tested device has a controllable deflation rate and allows simultaneous measurements with the mercury sphygmomanometers. In addition, the investigators will be performing 6 set of measurements instead of 4.
- Conditions
- Essential Hypertension
- Being tested
- Blood Pressure Measurement
- Keywords
- Blood pressure measuring devices, Essential Hypertension, Automated blood pressure measurement
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure MeasurementOther
All patients have their blood pressure measured simultaneously by two observers using parallel connected mercury sphygmomanometers and by a supervisor using the tested device, NISSEI DM 3000. Six sets of measurements are performed.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All eligible patients in the study consist a single group and the same intervention is assigned to all of them. Receives: Other: Blood Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure Measured by Tested Device.
Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.
Measured: 3 months
Systolic Blood Pressure Measured With Mercury Sphygmomanometer.
Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.
Measured: 3 months
Diastolic Blood Pressure Measured by Tested Device.
Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.
Measured: 3 months
Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.
Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Essential 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George S. Stergiou, University of Athens
- Investigators
- George S Stergiou, MD, Study chair, Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120990
- Sponsor's protocol ID
- Hybrid BP Monitor Validation
- Acronym
- NISSEI
- Status last verified
- Apr 2012
- First submitted
- 6 May 2010
- Last updated
- 18 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Hybrid Blood Pressure Monitor to Replace the Mercury Standard for Validation Studies According to Modified Criteria of the European Society of Hypertension International Protocol 2010
- ClinicalTrials.gov ID
- NCT01120990
- Acronym / sponsor ID
- NISSEI / Hybrid BP Monitor Validation
- Conditions
- Essential Hypertension
- Keywords
- Blood pressure measuring devices, Essential Hypertension, Automated blood pressure measurement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Posted 7 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the accuracy of a Blood Pressure Measuring Device with a digital display-column, NISSEI DM 3000, according to an adaptation of the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults".
Detailed description
According to the "European Society of Hypertension International Protocol Revision 2010 for the Validation of Blood Pressure Measuring Devices in Adults", 33 patients have their blood pressure measured by two observers using parallel connected mercury sphygmomanometers, blinded from each other's result, and then by the supervisor using the tested device, NISSEI DM 3000. The measurements using the mercury sphygmomanometers are repeated 5 times and in between them, 4 measurements using the tested device take place. If the results of the comparison of these measurements according to the analysis required by the protocol, meet the required criteria, the device is regarded as "Pass", otherwise as "Fail".
In this study, instead of consecutive, simultaneous measurements of the two mercury sphygmomanometers and tha tested device will be taking place. This will be so to exclude any inaccuracy due to blood pressure variability and because the tested device has a controllable deflation rate and allows simultaneous measurements with the mercury sphygmomanometers. In addition, the investigators will be performing 6 set of measurements instead of 4.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Other: Blood Pressure MeasurementAll eligible patients in the study consist a single group and the same intervention is assigned to all of them. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 25 years of age
- Sinus rhythm
- Informed consent
Key exclusion criteria (5 listed)
- Sustained arrhythmia
- Pregnancy
- Poor quality Korotkoff sounds
- Unavailable cuff size
- Completed blood pressure range (according to protocol)
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 |
|---|---|---|
| Blood Pressure MeasurementAll patients have their blood pressure measured simultaneously by two observers using parallel connected mercury sphygmomanometers and by a supervisor using the tested device, NISSEI DM 3000. Six sets of measurements are performed. | Other | All patients |
Primary outcome
Systolic Blood Pressure Measured by Tested Device.
Time frame: 3 months
Mean Systolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.
Systolic Blood Pressure Measured With Mercury Sphygmomanometer.
Time frame: 3 months
Mean Systolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.
Diastolic Blood Pressure Measured by Tested Device.
Time frame: 3 months
Mean Diastolic Blood pressure value of all BP measurements made by the tested device in all patients included in the analysis.
Diastolic Blood Pressure Measured With Mercury Sphygmomanometer.
Time frame: 3 months
Mean Diastolic Blood pressure value of all BP measurements made by the two observers with mercury sphygmomanometers in all patients included in the analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George S Stergiou, MD study chair
Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood Pressure Measurement in people with Essential Hypertension, run by University of Athens at 1 site in Greece.
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 3 inclusion and 5 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 Apr 2012. 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 Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Systolic Blood Pressure Measured by Tested Device. (time frame: 3 months). The study lists 4 primary outcomes in all. 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 Apr 2012.