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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Blood Pressure Monitoring
Sponsored by
University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring Hypertension, Nocturnal BP dipping, Home Blood pressure Monitoring, Ambulatory Blood Pressure Monitoring

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sotiria General Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients

Arm Description

All eligible patients in the study consist a single group and the same intervention is assigned to all of them.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 25, 2011
Last Updated
July 8, 2012
Sponsor
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01460732
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Nocturnal BP dipping, Home Blood pressure Monitoring, Ambulatory Blood Pressure Monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Other
Arm Description
All eligible patients in the study consist a single group and the same intervention is assigned to all of them.
Intervention Type
Device
Intervention Name(s)
Blood Pressure Monitoring
Other Intervention Name(s)
Microlife WatchBP Home Nocturnal, Microlife WatchBP O3
Intervention Description
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
Primary Outcome Measure Information:
Title
Awake Systolic Home Blood Pressure Measurement
Description
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Time Frame
2 weeks
Title
Awake Diastolic Home Blood Pressure Measurement
Description
Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.
Time Frame
2 weeks
Title
Asleep Systolic Home Blood Pressure Measurement
Description
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Time Frame
2 weeks
Title
Asleep Diastolic Home Blood Pressure Measurement
Description
Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.
Time Frame
2 weeks
Title
Awake Systolic Ambulatory Blood Pressure Measurement
Description
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.
Time Frame
2 weeks
Title
Awake Diastolic Ambulatory Blood Pressure Measurement
Description
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.
Time Frame
2 weeks
Title
Asleep Systolic Ambulatory Blood Pressure Measurement
Description
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.
Time Frame
2weeks
Title
Asleep Diastolic Ambulatory Blood Pressure Measurement
Description
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.
Time Frame
2weeks
Secondary Outcome Measure Information:
Title
Dippers Defined by ABPM and HBPM-Nocturnal
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Sotiria General Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece

12. IPD Sharing Statement

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

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