Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, Detection of Non-Dippers

Not Applicable

Completed

Conditions: Hypertension

Interventions: Device: Blood Pressure Monitoring

Registration Number: NCT01460732

Lead Sponsor: University of Athens

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

Inclusion Criteria

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Blood Pressure Monitoring	All eligible patients in the study consist a single group and the same intervention is assigned to all of them.

Primary Outcome Measures

Name	Time	Method
Awake Systolic Home Blood Pressure Measurement	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	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	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	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Dippers Defined by ABPM and HBPM-Nocturnal	2 weeks	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.