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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Blood Pressure Monitoring

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11527
    • Sotiria General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All patients; 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; Other Names: Microlife WatchBP Home Nocturnal; Microlife WatchBP O3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	2weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks

Collaborators and Investigators

• Sponsor: University of Athens

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 27, 2011

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 8, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Hypertension; Ambulatory Blood Pressure Monitoring; Nocturnal BP dipping; Home Blood pressure Monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NOCTURNAL