Accuracy of AOBP in a Chinese Population

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454178
• Other study ID #: CUHK-188
• Status: Completed
• Start date: June 30, 2018
• Est. completion date: December 29, 2019

Study information

• Verified date: September 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 29, 2019
• Est. primary completion date: December 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

Diagnostic Test:
• WatchBP Office (BP measurement machine)
BP measurement: The nurse or assistant will leave the room after confirmed validity and the WatchBP will automatically measure BP for the participant at 1-minute intervals for 3 more readings; previous research showed that accurate BP readings could be obtained using 1-minute intervals. This is also the measuring method suggested by the manufacturer. The machine will automatically calculate the mean BP using the 3 readings. The mean BP value will be used for analysis. The diagnostic cutoff for diagnosing HT will be =135/85 for AOBP

Locations

Country	Name	City	State
Hong Kong	Lek Yuen Clinic	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare BP readings from AOBPs, ABPM, and traditional office BP	mean difference of systolic BP (SBP) and diastolic BP (DBP) between AOBP machines (WatchBP Office, BpTRU)/office BP and daytime ABPM will be compared by the two-tailed t-test; A Bland-Altman type plot will be shown for both comparisons. Pearson correlations will be used to compare mean readings of office BP, AOBP and daytime ABPM.	1 year
Secondary	sensitivity/specificity, positive and negative predictive value of AOBP vs traditional BP measurement	sensitivity/specificity, positive and negative predictive value of diagnosing elevated BP, masked hypertension, and white-coat hypertension of AOBP and office BP will be compared using ABPM as the gold standard	1 year