An interventional study of Blood Pressure Monitoring in Hypertension, sponsored by University of Athens. Completed at 1 site in Greece. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by University of Athens · Not applicable, Interventional, and Diagnostic
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 81 is close to the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Athens is the lead sponsor of 133 studies on the registry; 19 are open to participants now.
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Inclusion Criteria:ma
Exclusion Criteria:
All eligible patients in the study consist a single group and the same intervention is assigned to all of them.
Device: Blood Pressure Monitoring
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
Also known as: Microlife WatchBP Home Nocturnal, Microlife WatchBP O3
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2weeks
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.
Time frame: 2 weeks
| Milestone | All Patients |
|---|---|
| Started | 81 |
| Completed | 81 |
| Not completed | 0 |
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
| mmHg | All Patients |
|---|---|
| Awake Systolic Home Blood Pressure Measurement | 131.5 ± 11.2 |
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
| mmHg | All Patients |
|---|---|
| Awake Diastolic Home Blood Pressure Measurement | 79.9 ± 7.8 |
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
| mmHg | All Patients |
|---|---|
| Asleep Systolic Home Blood Pressure Measurement | 114.8 ± 12.2 |
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
| mmHg | All Patients |
|---|---|
| Asleep Diastolic Home Blood Pressure Measurement | 66.6 ± 7.9 |
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.
| mmHg | All Patients |
|---|---|
| Awake Systolic Ambulatory Blood Pressure Measurement | 130.0 ± 11.6 |
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.
| mmHg | All Patients |
|---|---|
| Awake Diastolic Ambulatory Blood Pressure Measurement | 81.0 ± 7.6 |
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.
| mmHg | All Patients |
|---|---|
| Asleep Systolic Ambulatory Blood Pressure Measurement | 115.2 ± 10.7 |
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.
| mmHg | All Patients |
|---|---|
| Asleep Diastolic Ambulatory Blood Pressure Measurement | 67.6 ± 6.9 |
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.
| percentage of patients | ABPM | HBPM-Nocturnal |
|---|---|---|
| Dippers Defined by ABPM and HBPM-Nocturnal | 84 | 78 |
Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | — | 0/81 (0%) | 0/81 (0%) |
| Age, Categorical(Participants) | All Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 62 |
| >=65 years | 19 |
| Age Continuous(years) | All Patients |
|---|---|
| Mean | 58.1 ± 10.7 |
| Sex: Female, Male(Participants) | All Patients |
|---|---|
| Female | 38 |
| Male | 43 |
| Region of Enrollment(participants) | All Patients |
|---|---|
| Greece | 81 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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