Primary Objective: To investigate the agreement between cuffless blood pressure monitoring values and ABPM values in patients treated for hypertension.- Expressed as a mean difference between cuffless BP monitoring values and ABPM values- The…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint are twofold:
1. Mean differences in systolic blood pressure (SBP) and diastolic blood
pressure (DBP) between cuffless BP monitoring and ABPM values.
2. Standard deviations of the mean differences between cuffless BP monitoring,
ABPM, oscillometric HBPM, a-OBP and u-OBP
Secondary outcome
For all of the secondary objectives formulated in chapter 2 the study
parameters are the same as the main study parameters.
Other study variables that will be recorded for each study participant:
Age, gender, arm circumference, medical history, BMI, medication use, and
smoking behavior.
Background summary
Hypertension is the dominant risk factor for cardiovascular disease, including
coronary heart disease stroke, heart failure, chronic kidney disease,
arrhythmia and cognitive impairment, and is a major cause of premature death
worldwide (1,2). The global prevalence of hypertension in adults aged 30 - 79
years is an estimated 32-34%, corresponding to approximately 1.28 billion
people worldwide (2). Accurate blood pressure (BP) measurement is essential for
proper diagnosis of hypertension and typically involves an auscultatory or
(semi)automatic oscillometric sphygmomanometer (3).
There are two approaches for BP recording: office BP (OBP) and out-of-office BP
measurement. The diagnosis of hypertension has traditionally been based on OBP.
Although OBP recordings are taken rapidly, they are easily disturbed, leading
to incorrect diagnosis of normo- and hypertension, known as *masked
hypertension* and *white-coat hypertension* (4,5). Moreover, OBP measurements
have shown to be inferior in predicting hypertension-mediated organ damage,
compared to out-of-office BP measurements (6). Therefore, out-of-office BP
monitoring is recommended for diagnosis and monitoring of hypertension by
several guidelines (3,7).
Out-of-office BP monitoring includes ambulatory BP monitoring (ABPM) and home
BP monitoring (HBPM). ABPM is a technique in which BP is automatically recorded
every 15-30 min over a defined period (usually 24 hours) during daily
activities and sleeping hours. HBPM refers to self-monitoring of BP by patients
outside a clinical setting, often at their own homes. ABPM has several
advantages over HBPM, including the availability of day- and nighttime BP
measurements, which is clinically relevant because a high night-to-day ratio
(>0.9) is associated with an increased cardiovascular risk (8). However, HBPM
is a less expensive and better tolerated method, and may empower patients to
take an active role in managing their own health. Studies have shown that
self-monitoring as part of a self-management strategy increases patient
commitment, medication adherence and BP control, especially when combined with
other interventions such as counselling and education (9,10).
Although self-monitoring of BP has several advantages, the use of an
semi-automatic oscillometric device may be inconvenient and uncomfortable for
patients (11). Errors can easily occur through incorrect performance or
documentation of self-recorded readings. It has been demonstrated that HBPM
values reported by patients often do not match the readings automatically
stored in the device memory (12). Moreover, the oscillometric device provides
only intermittent BP readings, failing to capture BP variability throughout the
day.
The cuffless BP monitor offers a new strategy for measurement of BP at home.
Cuffless BP monitoring, in which automated BP measurements are obtained 24/7
using a noninvasive CE certified wrist bracelet, could enhance reliability of
HBPM and might provide valuable insight into long-term BP patterns. Previous
studies have validated a commercially available cuffless monitor (the Aktiia BP
monitor) according to the ANSI/AAMI/ISO 81060-2:2013 protocol (13-15). Another
study, including 52 participants who had been enrolled in a 12-week cardiac
rehabilitation program following myocardial infarction or heart surgery,
reported non-significant differences between a commercially available cuffless
BP monitor and ABPM for measuring SBP (1.6 ± 10.5 mmHg, P = 0.306), and DBP
(*2.2 ± 8.0 [*4.5, 0.1] mmHg, P = 0.058) (16). However, there was not
sufficient power to draw firm conclusions. In order to further assess whether
cuffless BP monitoring is suitable for use in daily clinical practice, it is
essential to compare this new BP method with more conventional BP methods.
The present study will be a follow-up study of the AMUSE-BP (17). The AMUSE-BP
study, which compared several BP methods in order to determine the clinical
value of app-assisted HBPM, reported considerable discrepancy between
app-assisted HBPM and the reference standard ABPM. This observation may in part
be explained by the fact that the conditions in which BP is measured greatly
differ between the two measurement methods. Since cuffless BP monitoring and
ABPM both measure BP 24 hours a day, it will be particularly interesting to
evaluate the agreement between these two methods.
Therefore, we designed the AMUSE-BP-2 study, an open five-way crossover study
to compare cuffless BP monitoring to the five most used BP measurement methods.
The five methods used are: (I) cuffless BP monitoring (II) ABPM (III)
oscillometric HBPM and (IV) attended office BP (a-OBP) and (V) unattended
office BP (u-OBP). The primary objective of the AMUSE-BP-2 study will be the
comparison, expressed as agreement, between cuffless BP monitoring and
reference standard ABPM. The findings from the AMUSE-BP-2 study will answer the
question if and how to use cuffless monitoring in comparison with conventional
BP methods for the diagnosis and monitoring of hypertension. Given the
potential benefits of cuffless BP monitoring for patients, the AMUSE-BP-2 study
is of vital importance for hypertension care worldwide.
Study objective
Primary Objective: To investigate the agreement between cuffless blood pressure
monitoring values and ABPM values in patients treated for hypertension.
- Expressed as a mean difference between cuffless BP monitoring values and ABPM
values
- The cuffless BP value is composed of a 7-day average of SBP and DBP
- The ABPM value is composed of a 7-day average of SBP and DBP
Secondary Objective(s):
a) To investigate the agreement between cuffless BP monitoring values and
oscillometric HBPM values in patients treated for hypertension.
- Expressed as a mean difference between cuffless BP monitoring values and ABPM
values
- The cuffless BP and oscillometric HBPM values are composed of a 7-day average
of SBP and DBP
b) To investigate the agreement between cuffless BP monitor values and attended
OBP values in patients treated for hypertension.
- Expressed as a mean difference between a cuffless BP values and attended OBP
values
- The cuffless BP value is composed of a 7-day average of SBP and DBP
- The OBP value is composed of the average of SBP and DBP from 3 subsequent
measurements performed 1-2 minutes apart
c) To investigate the agreement between cuffless BP monitoring values and
unattended OBP values in patients treated for hypertension.
- Expressed as a mean difference between cuffless BP values and unattended OBP
values
- The cuffless BP value is composed of a 7-day average of SBP and DBP
- The unattended OBP value is composed of the average of SBP and DBP from 3
subsequent measurements performed 1-2 minutes apart
Study design
The study design will be a randomized controlled 5-way cross-over study. The 5
periods each contain 1 out of 5 BP methods:
(1) cuffless BP monitoring (7-day measurement)
(2) ambulatory blood pressure monitoring (ABPM) (24-hour)
(3) home blood pressure monitoring (HBPM) (7-day measurement)
(4) attended office blood pressure (a-OBP) (single office visit)
(5) unattended office blood pressure (u-OBP) (single office visit)
Study burden and risks
Patients are invited to participate in a randomized 5-arm crossover study in
which a total of 5 different blood pressure measurement methods are
investigated (hence 5 arms). The total duration of the study is a minimum of 22
days and a maximum of 31 days, depending on the randomly assigned randomization
arm and the planned measurement schedule. All blood pressure measurement
methods are safe and are well accepted by the vast majority of patients.
Elevated blood pressure is the dominant risk factor for the development of
cardiovascular diseases. Cardiovascular diseases are the leading cause of death
worldwide. Patients being treated for hypertension require multiple blood
pressure measurements for their treatment, which justifies participation in
this study. All methods are performed with CE-certified and validated blood
pressure devices. These methods are safe and generally well-tolerated by
patients. The potential benefit for participants is insight into available
blood pressure methods and corresponding blood pressure values, which can
improve patient engagement and treatment adherence. This offers patients and
health care professionals the opportunity to make a shared decision on the
preferred BP measurement method for follow-up.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
1. Age of 18 years or older
2. Documented medical history of hypertension in local hospital electronic
patient record
3. Stable dose of anti-hypertensive medication for at least 2 months (includes
no current antihypertensive medication, diagnosis hypertension is sufficient)
4. SBP>90 and <180 mmHg and DBP >60 and <110mmHg at inclusion screening by
attended OBP
5. Dutch, French and/or English language capable for reading subject
information letter and in-app instructions.
6. Smartphone or tablet owner with either iOS or Android installed as operating
system.
Exclusion criteria
1. SBP >180 mmHg and/or DBP >110mmHg at inclusion screening visit (measured by
attended OBP method).
2. Any BP that according to the treating physician is not adequately controlled
and needs medication adjustment < 2 months or within the study time period.
3. Recent (<2 months) anti-hypertensive medication changes (including
diuretics).
4. Recent start or change in dosing of alpha-blockers prescribed for other
purpose than blood pressure control (for example benign prostate hypertrophy).
5. Unstable or uncontrolled endocrine disease (e.g. thyroid disease, Cushing*s
or Addison*s disease) with the exception of diabetes mellitus.
6. Arrhythmias that prevent any BP measurement device to correctly measure BP
during inclusion screening visit; such as supraventricular arrhythmias or
atrial ventricular block. Known arrhythmias, but not clinically present during
inclusion screening is not an exclusion criterion.
7. Heart failure grade 2 or higher on the New York Heart Association (NYHA)
Functional Classification.
8. Documented missed outpatient clinic appointments (2 or more the last 6
months).
9. Documented therapy non-adherence (e.g. biochemical proven medication
non-adherence, known or highly suspected medication non-adherence by treating
physician, proven direct observed therapy effect in BP).
10. Participants cannot plan a measurement schedule with a minimum of 22 and a
maximum of 31-day period participation or a minimum of 4 and maximum of 5
hospital visits due to logistical issues or scheduling issues of any kind.
11. Physical inability to perform an home BP measurement.
12. Active pregnancy or planning trying to get pregnant during the study
period.
Design
Recruitment
Medical products/devices used
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 | NL86158.041.24 |