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

NCT ID: NCT01460732

Last Updated: 2012-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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

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Hypertension

Keywords

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Hypertension Nocturnal BP dipping Home Blood pressure Monitoring Ambulatory Blood Pressure Monitoring

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All patients

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Group Type OTHER

Blood Pressure Monitoring

Intervention Type DEVICE

Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring

Interventions

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Blood Pressure Monitoring

Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring

Intervention Type DEVICE

Other Intervention Names

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Microlife WatchBP Home Nocturnal Microlife WatchBP O3

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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George S. Stergiou

Associate Professor of Medicine and Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sotiria General Hospital

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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NOCTURNAL

Identifier Type: -

Identifier Source: org_study_id