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

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ClinicalTrials.gov Identifier: NCT01460732
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : June 12, 2012
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypertension Device: Blood Pressure Monitoring Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Awake Systolic Home Blood Pressure Measurement [ Time Frame: 2 weeks ]
    Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.

  2. Awake Diastolic Home Blood Pressure Measurement [ Time Frame: 2 weeks ]
    Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.

  3. Asleep Systolic Home Blood Pressure Measurement [ Time Frame: 2 weeks ]
    Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.

  4. Asleep Diastolic Home Blood Pressure Measurement [ Time Frame: 2 weeks ]
    Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.

  5. Awake Systolic Ambulatory Blood Pressure Measurement [ Time Frame: 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.

  6. Awake Diastolic Ambulatory Blood Pressure Measurement [ Time Frame: 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.

  7. Asleep Systolic Ambulatory Blood Pressure Measurement [ Time Frame: 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.

  8. Asleep Diastolic Ambulatory Blood Pressure Measurement [ Time Frame: 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 :
  1. Dippers Defined by ABPM and HBPM-Nocturnal [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460732


Locations
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Greece
Sotiria General Hospital
Athens, Greece, 11527
Sponsors and Collaborators
University of Athens
More Information
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Responsible Party: George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens
ClinicalTrials.gov Identifier: NCT01460732    
Other Study ID Numbers: NOCTURNAL
First Posted: October 27, 2011    Key Record Dates
Results First Posted: June 12, 2012
Last Update Posted: July 10, 2012
Last Verified: July 2012
Keywords provided by George S. Stergiou, University of Athens:
Hypertension
Nocturnal BP dipping
Home Blood pressure Monitoring
Ambulatory Blood Pressure Monitoring
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases