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Completed

NCT Number: NCT01460732

Home Versus Ambulatory Monitoring, Diurnal Blood Pressure Profile, 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sotiria General Hospital

Athens, 11527, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood Pressure Monitoring

Device

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

Other names: Microlife WatchBP Home Nocturnal, Microlife WatchBP O3

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

Home Versus Ambulatory Monitoring in the Assessment of the Diurnal Blood Pressure Profile and the Detection of Non-Dippers

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2011
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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