Clinical trial NCT03454178: Accuracy of AOBP in a Chinese Population
Official title: Sensitivity, Specificity, and Positive and Negative Predictive Values of Automatic Office Blood Pressure Measurement and Traditional Office Blood Pressure Measurement in a Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: AOBP
ABPM
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients in primary care

Brief summary: Background: Traditional office blood pressure (BP) measurement is often inaccurate and is inferior to out-of-office measurements, such as ambulatory blood pressure monitoring (ABPM), in predicting cardiovascular outcomes. A relatively new BP measurement method, called Automatic Office Blood Pressure measurement (AOBP), may provide similar BP readings to ABPM (latest clinical gold standard for BP measurements) and can easily be conducted in clinics. AOBP machines measure BP repeatedly 3-5 times with 1-min intervals and automatically provide the mean BP value. While AOBP was used in landmark trials (e.g. SPRINT trial) and was shown to eliminate white-coat effect, AOBP is rarely used in Hong Kong partly because there is no data concerning the accuracy of AOBP in Chinese. Almost all previous AOBP research used BpTRU (AOBP model), but BpTRU manufacturer was shut down permanently.

Aim: To assess if WatchBP Office (another AOBP model) has superior diagnostic accuracy than traditional office BP measurements, when compared to ABPM readings.

Method: 150 Chinese adult patients with a diagnosis of essential hypertension will be recruited consecutively from a Government-funded primary care clinic. All patients will have their BP measured by a 48-hour ABPM, a WatchBP office, and two traditional office blood pressure measurements.

ABPM will be considered the gold standard; sensitivity, specificity, positive and negative predictive values of AOBP and traditional BP to diagnose elevated BP level, masked hypertension and white-coat hypertension will be calculated and compared

Implication: if WatchBP provides closer BP readings to ABPM, this can lead to its implementation in routine clinical practice


Eligibility criteria: Inclusion Criteria:

* diagnosis of essential hypertension

Exclusion Criteria:

* (i) severe hypertension as defined by clinical systolic BP ≥180 mmHg and/or diastolic BP ≥110 mmHg (because they may need emergency treatment and it is unethical to delay such treatment due to the proposed project), (ii) inability to provide consent, (iii) pregnancy, (iv) night-time occupations (we need to compare AOBP and clinic BP readings to daytime ABPM average when the patient should be awake), (v) are occupational drivers (because potential dangers in driving could occur when patients are asked to remain still), (vi) receiving anti-coagulants (to prevent bruises when using ABPM), (vii) with known atrial fibrillation (as ABPMs and AOBP use have not been validated in this group)

Primary outcomes:
measure: compare BP readings from AOBPs, ABPM, and traditional office BP
timeFrame: 1 year
Secondary outcomes:
measure: sensitivity/specificity, positive and negative predictive value of AOBP vs traditional BP measurement
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Lek Yuen Clinic
Study officials:
References: