The main goal is to assess the difference in average systolic bloodpressure between self-initiated and fully automated measurement, thereby evaluating the influence of the *auto-cuff* response in an out-of-office setting. Secondary goals are…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hypertensie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The chief parameter we will be studying is the difference in average systolic
blood pressure (in mmHg), defined as the mean systolic blood pressure measured
with the self-initiated method compared to the mean systolic blood pressure
measured with the fully-automated method.
Secondary outcome
Secondary parameters we will study are:
- The difference in average diastolic blood pressure (in mmHg), defined as the
mean diastolic blood pressure measured with the self-initiated method compared
to the mean diastolic blood pressure measured with the fully-automated method;
- The difference in average heartrate (in beats/minute).
Background summary
Hypertension plays a large role in cardiovascular disease, the world*s leading
cause of death. The need for accurate detection therefore seems obvious. There
is considerable evidence that HBPM and ABPM are more accurate and precise in
diagnosing hypertension and better predict clinical outcomes compared to office
BP measurement. However, recent studies show that these two types of
measurement are not interchangeable: HBPM frequently shows higher average blood
pressure values compared to daytime ABPM, although this is not associated with
an increase in cardiovascular disease risk or hypertensive organ damage. We
recently showed that self-initiated BP measurement results in a higher blood
pressure compared to fully-automated measurements, suggesting an anticipatory
reaction to self-measurement called the 'auto-cuff' response. This has only
been studied in an in-office setting. In the present proposal our aim is to
examine differences in blood pressure between self-initiated blood pressure
readings and fully-automated measurement in an out-of-office setting. We
hypothesize that there is an anticipatory reaction with self-initiated blood
pressure measurements, albeit possibly not with as much of a blood pressure
difference as in our previous study.
Study objective
The main goal is to assess the difference in average systolic bloodpressure
between self-initiated and fully automated measurement, thereby evaluating the
influence of the *auto-cuff* response in an out-of-office setting. Secondary
goals are assessing the difference in average diastolic blood pressure and
heartrate.
Study design
This study is designed as a single centre, two-visit, cross-over study. After
screening for eligibility and given informed consent, all subjects will fill in
a questionnaire and cardiovascular risk will be assessed. Subsequently, all
patients will perform blood pressure measurement twice daily, by both the
self-initiated as well as by the fully-automated method over the course of 10
weekdays.
Study burden and risks
The results of this study are beneficial to our understanding and application
of blood pressure measurement in an out-of-office setting, increasing quality
of blood pressure monitoring and thereby increasing capability to identify and
treat susceptible subjects. The burden and risks of participation are
negligible, considering all measurements are safe and non-invasive. Moreover,
the study comprises of only two short visits of approximately 20 minutes each
including questionnaire and instructions, in addition to self-measurement at
home for a total of 10 weekdays, taking up about 15 minutes each day. There is
no individual benefit from participation in this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Aged *18 years;
- Patient visiting the outpatient clinic of the Department of Cardiology and Department of Internal/ Vascular Medicine of the AMC.
Exclusion criteria
- Pregnancy;
- Severe heart rate irregularities of any cause;
- Severe uncontrolled hypertension (mean BP>200/120 mmHg in the clinic);
- Not able to follow instructions for BP measurement for any reason;
- Recently changed BP lowering medication (<4 weeks);
- Inability or unwillingness to comply with the protocol requirements, or deemed by
investigator to be unfit for the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66678.018.18 |