Hypertension
Conditions
Keywords
Hypertension, Nocturnal BP dipping, Home Blood pressure Monitoring, Ambulatory Blood Pressure Monitoring
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.
Interventions
DEVICEBlood Pressure Monitoring
Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
Sponsors
University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asleep Diastolic Ambulatory Blood Pressure Measurement | 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. |
| Awake Systolic Home Blood Pressure Measurement | 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 | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Dippers Defined by ABPM and HBPM-Nocturnal | 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. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients analyzed | 81 |
| Total | 81 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants |
| Age Continuous | 58.1 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment Greece | 81 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
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.
Time frame: 2weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Asleep Diastolic Ambulatory Blood Pressure Measurement | 67.6 mmHg | Standard Deviation 6.9 |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Asleep Diastolic Home Blood Pressure Measurement | 66.6 mmHg | Standard Deviation 7.9 |
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.
Time frame: 2weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Asleep Systolic Ambulatory Blood Pressure Measurement | 115.2 mmHg | Standard Deviation 10.7 |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Asleep Systolic Home Blood Pressure Measurement | 114.8 mmHg | Standard Deviation 12.2 |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Awake Diastolic Ambulatory Blood Pressure Measurement | 81.0 mmHg | Standard Deviation 7.6 |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Awake Diastolic Home Blood Pressure Measurement | 79.9 mmHg | Standard Deviation 7.8 |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Awake Systolic Ambulatory Blood Pressure Measurement | 130.0 mmHg | Standard Deviation 11.6 |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Awake Systolic Home Blood Pressure Measurement | 131.5 mmHg | Standard Deviation 11.2 |
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.
Time frame: 2 weeks
Population: All patients who had their Daytime and Nocturnal BP assessed by both methods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Dippers Defined by ABPM and HBPM-Nocturnal | 84 percentage of patients |
| HBPM-Nocturnal | Dippers Defined by ABPM and HBPM-Nocturnal | 78 percentage of patients |