HypertensionNCT01460732
Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers
A study testing Blood Pressure Monitoring in people with Hypertension, run by University of Athens at 1 site in Greece.
Trial summary
This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include: Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Blood Pressure Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2010to Dec 2011
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for high blood pressure
- Age over 30 years
- Untreated for hypertension or under stable treatment for 4 weeks or more
- Patients physically and mentally capable for self-measurement of blood pressure at home
- Written informed consent to participate in the study
Who cannot join
- Sustained arrythmia
- Pregnancy
- Symptomatic cardiovascular disease
- Any other serious disease (renal failure, heart failure, malignancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers
This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include:
Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.
Read the detailed description
Eligible patients, as described in Inclusion/Exclusion Criteria, will be instructed to use Microlife WatchBP Home-Nocturnal oscillometric device, in order to measure their BP two times with one-minute interval, in the morning between 6 and 9 am and in the evening between 6 and 9 pm respectively for six days. These six days shall be normal working days, selected be the patient, within a time-frame of two weeks approximately. Patients should be sitting for at least five minutes and calm. During three out of those six days, they will apply and activate the same device, in order to take BP measurements while they will be asleep. Those measurements are going to be taken automatically by the device, the first 2-hours after the activation and another two with one-hour interval. Measurements will be averaged as awake and asleep BP values, with a potential to derive, if so wished, separate averages of awake-morning and awake-evening BP values.
Microlife WatchBP O3 Ambulatory Blood Pressure Measurement (ABPM) device will be applied by a doctor to each patient and it will be removed the next day by a doctor. BP measurements will be performed every 20 minutes for 24 hours. BP measurements taken during awake and asleep hours for each patient, will be analyzed separately.
Additionally, triplicate sitting Clinic Blood Pressure measurements, with one-minute interval, will be performed with the Microlife WatchBP Home-Nocturnal device during each patient's visit at the Hypertension Center. Patients will visit Hypertension Center three times, one to apply the ABPM device and one to remove it and provide the Microlife WatchBP Home-Nocturnal device and another one to bring it back. This will take approximately two weeks.
- Conditions
- Hypertension
- Being tested
- Blood Pressure Monitoring
- Keywords
- Hypertension, Nocturnal BP dipping, Home Blood pressure Monitoring, Ambulatory Blood Pressure Monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure MonitoringDevice
Also called Microlife WatchBP Home Nocturnal, Microlife WatchBP O3
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
| 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: Device: Blood Pressure Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Awake Systolic Home Blood Pressure Measurement
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Measured: 2 weeks
Awake Diastolic Home Blood Pressure Measurement
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Measured: 2 weeks
Asleep Systolic Home Blood Pressure Measurement
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Measured: 2 weeks
Asleep Diastolic Home Blood Pressure Measurement
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Measured: 2 weeks
Awake Systolic Ambulatory Blood Pressure Measurement
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Measured: 2 weeks
Awake Diastolic Ambulatory Blood Pressure Measurement
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Measured: 2 weeks
Asleep Systolic Ambulatory Blood Pressure Measurement
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Measured: 2weeks
Asleep Diastolic Ambulatory Blood Pressure Measurement
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Measured: 2weeks
Secondary outcomes (1)
Dippers Defined by ABPM and HBPM-Nocturnal
As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2011
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 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460732
- Sponsor's protocol ID
- NOCTURNAL
- Status last verified
- Jul 2012
- First submitted
- 25 Oct 2011
- Last updated
- 10 Jul 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 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers
- ClinicalTrials.gov ID
- NCT01460732
- Acronym / sponsor ID
- NOCTURNAL
- Conditions
- Hypertension
- Keywords
- Hypertension, Nocturnal BP dipping, Home Blood pressure Monitoring, Ambulatory Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Posted 12 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include:
Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.
Detailed description
Eligible patients, as described in Inclusion/Exclusion Criteria, will be instructed to use Microlife WatchBP Home-Nocturnal oscillometric device, in order to measure their BP two times with one-minute interval, in the morning between 6 and 9 am and in the evening between 6 and 9 pm respectively for six days. These six days shall be normal working days, selected be the patient, within a time-frame of two weeks approximately. Patients should be sitting for at least five minutes and calm. During three out of those six days, they will apply and activate the same device, in order to take BP measurements while they will be asleep. Those measurements are going to be taken automatically by the device, the first 2-hours after the activation and another two with one-hour interval. Measurements will be averaged as awake and asleep BP values, with a potential to derive, if so wished, separate averages of awake-morning and awake-evening BP values.
Microlife WatchBP O3 Ambulatory Blood Pressure Measurement (ABPM) device will be applied by a doctor to each patient and it will be removed the next day by a doctor. BP measurements will be performed every 20 minutes for 24 hours. BP measurements taken during awake and asleep hours for each patient, will be analyzed separately.
Additionally, triplicate sitting Clinic Blood Pressure measurements, with one-minute interval, will be performed with the Microlife WatchBP Home-Nocturnal device during each patient's visit at the Hypertension Center. Patients will visit Hypertension Center three times, one to apply the ABPM device and one to remove it and provide the Microlife WatchBP Home-Nocturnal device and another one to bring it back. This will take approximately two weeks.
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 | Device: Blood Pressure MonitoringAll eligible patients in the study consist a single group and the same intervention is assigned to all of them. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients referred for high blood pressure
- Age over 30 years
- Untreated for hypertension or under stable treatment for 4 weeks or more
- Patients physically and mentally capable for self-measurement of blood pressure at home
- Written informed consent to participate in the study
Key exclusion criteria (4 listed)
- Sustained arrythmia
- Pregnancy
- Symptomatic cardiovascular disease
- Any other serious disease (renal failure, heart failure, malignancy)
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 MonitoringAlso: Microlife WatchBP Home Nocturnal, Microlife WatchBP O3Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring | Device | All patients |
Primary outcome
Awake Systolic Home Blood Pressure Measurement
Time frame: 2 weeks
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Awake Diastolic Home Blood Pressure Measurement
Time frame: 2 weeks
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Asleep Systolic Home Blood Pressure Measurement
Time frame: 2 weeks
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Asleep Diastolic Home Blood Pressure Measurement
Time frame: 2 weeks
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Awake Systolic Ambulatory Blood Pressure Measurement
Time frame: 2 weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Awake Diastolic Ambulatory Blood Pressure Measurement
Time frame: 2 weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Asleep Systolic Ambulatory Blood Pressure Measurement
Time frame: 2weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
Asleep Diastolic Ambulatory Blood Pressure Measurement
Time frame: 2weeks
An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.
1 secondary outcome
Dippers Defined by ABPM and HBPM-Nocturnal
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Pressure Monitoring in people with 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 5 inclusion and 4 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 10 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 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?
Awake Systolic Home Blood Pressure Measurement (time frame: 2 weeks). The study lists 8 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 10 Jul 2012.