Hypertension Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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