Clinical trial NCT01460732: Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers
Official title: Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Nocturnal BP dipping
Home Blood pressure Monitoring
Ambulatory Blood Pressure Monitoring
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2011-10-27
Enrollment: 81
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Eligibility criteria: Inclusion Criteria:ma

* 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

Exclusion Criteria:

* Sustained arrythmia
* Pregnancy
* Symptomatic cardiovascular disease
* Any other serious disease (renal failure, heart failure, malignancy)

Primary outcomes:
measure: Awake Systolic Home Blood Pressure Measurement
timeFrame: 2 weeks
measure: Awake Diastolic Home Blood Pressure Measurement
timeFrame: 2 weeks
measure: Asleep Systolic Home Blood Pressure Measurement
timeFrame: 2 weeks
measure: Asleep Diastolic Home Blood Pressure Measurement
timeFrame: 2 weeks
measure: Awake Systolic Ambulatory Blood Pressure Measurement
timeFrame: 2 weeks
measure: Awake Diastolic Ambulatory Blood Pressure Measurement
timeFrame: 2 weeks
measure: Asleep Systolic Ambulatory Blood Pressure Measurement
timeFrame: 2weeks
measure: Asleep Diastolic Ambulatory Blood Pressure Measurement
timeFrame: 2weeks
Secondary outcomes:
measure: Dippers Defined by ABPM and HBPM-Nocturnal
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Sotiria General Hospital
Study officials:
References: