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

• 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: University of Athens
• Information provided by (Responsible Party): George S. Stergiou, University of Athens

Tracking Information

• First Submitted Date: October 25, 2011
• First Posted Date: October 27, 2011
• Results First Submitted Date: February 5, 2012
• Results First Posted Date: June 12, 2012
• Last Update Posted Date: July 10, 2012
• Study Start Date: November 2010
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2012)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: October 26, 2011)

• Difference between daytime and night-time Systolic Blood Pressure assessed by Home Blood Pressure Measurement [ Time Frame: 2 weeks ]
• Difference between daytime and night-time Diastolic Blood Pressure assessed by Home Blood Pressure Measurement [ Time Frame: 2 weeks ]
• Difference between daytime and night-time Systolic Blood Pressure assessed by Ambulatory Blood Pressure Measurement [ Time Frame: 2 weeks ]
• Difference between daytime and night-time Diastolic Blood Pressure assessed by Ambulatory Blood Pressure Measurement [ Time Frame: 2 weeks ]

Current Secondary Outcome Measures (submitted: July 8, 2012)

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.

Original Secondary Outcome Measures (submitted: October 26, 2011)

Percentage of Dippers and non-Dippers detected by Home and Ambulatory Blood Pressure measurement. [ Time Frame: 2 weeks ]

The subjects whose [(awake Blood Pressure-night Blood Pressure) / awake Blood Pressure] for Systolic and/or Diastolic Blood Pressure will be found ≥10% are defined as Dippers and those with <10%, as non-dippers.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Hypertension

Intervention

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

Study Arms

All patients

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

Intervention: Device: Blood Pressure Monitoring

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 1, 2012): 81
• Original Estimated Enrollment (submitted: October 26, 2011): 70
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Greece

Administrative Information

• NCT Number: NCT01460732
• Other Study ID Numbers: NOCTURNAL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: George S. Stergiou, University of Athens
• Study Sponsor: University of Athens
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Athens
• Verification Date: July 2012