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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460732
• Other study ID #: NOCTURNAL
• Status: Completed
• Phase: N/A
• First received: October 25, 2011
• Last updated: July 8, 2012
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Blood Pressure Monitoring
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring

Locations

Country	Name	City	State
Greece	Sotiria General Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No