The main goal is to assess differences in the maximal BP response compared to baseline using beat-to-beat registration of BP between subjects with and without established differences between home and ambulatory BP of at least 10/5 mmHg. As a…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The principal parameter is the difference in the maximal BP response between
subjects with and without previously established BP differences during
self-measurement of at least 10/5 mmHg compared to baseline values.
Secondary outcome
As secondary parameters we will consider the difference in HRV and BRS between
subjects with and without incremental BP differences during self-measurement
compared to basal values of at least 10/5 mmHg.
Background summary
The diagnosis of hypertension is hampered by intrinsic blood pressure (BP)
variability and anxiety responses that may systematically influence BP
measurement. Both influence the diagnostic value of BP measurement and the
prediction of cardiovascular disease. Anticipating a BP reading could induce a
pressor response at home as may happen in the clinic. Such an *auto-cuff*
response may be less significant during ambulatory BP measurement, where
recording is nearly continuous and less influenced by emotional factors such as
anxiety. We recently showed that differences between home and ambulatory BP do
not relate to hypertensive organ damage. In addition, patients with a
difference between home and ambulatory BP more frequently had a white coat
effect. This suggests that anxiety responses upon the self-measurement of BP
may exist. However, at present evidence regarding the possibility of such an
*auto cuff *response based on the self-measurement of BP is lacking.
Study objective
The main goal is to assess differences in the maximal BP response compared to
baseline using beat-to-beat registration of BP between subjects with and
without established differences between home and ambulatory BP of at least 10/5
mmHg. As a secondary objectives we will assess the difference in HRV and BRS
between subjects with and without incremental BP differences between home and
ambulatory BP of at least 10/5 mmHg.
Study design
This study is designed as a single centre, one visit only, observational study.
After screening for eligibility and given informed consent, all subjects will
undergo cardiovascular risk assessment. Thereafter, all subjects will undergo a
30 minutes continuous non-invasive finger arterial BP recording and meanwhile
10 consecutive self-BP measurements.
Study burden and risks
The results of this study will contribute to improve the quality of BP
monitoring and to better understand the characteristics of self-BP measurement
responses in order to better identify susceptible subjects. Individual subjects
will gain no direct benefit from this study. The risk and burden of
participating in this study is negligible since all the measurements that will
be performed are safe and non-invasive and the study comprises only one visit
of approximately 1 hr.
Meibergdreef 9
Amsterdam 1055AZ
NL
Meibergdreef 9
Amsterdam 1055AZ
NL
Listed location countries
Age
Inclusion criteria
Any subject who was previously enrolled in the home vs ambulatory BP study (AMSTERDAM study, NL 40014.018.12)
Exclusion criteria
* Pregnancy
* Severe heart rate irregularities of any cause
* Not able to follow instructions for BP measurement for any reason
* 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 | NL57135.018.16 |