Lek Yuen Clinic
Hong Kong
NCT Number: NCT03454178
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
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 year
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.
Time frame: 1 year
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
Chinese University of Hong Kong
Other
Sensitivity, Specificity, and Positive and Negative Predictive Values of Automatic Office Blood Pressure Measurement and Traditional Office Blood Pressure Measurement in a Chinese Population
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05610059
Aging, Behavior
Tucson, Arizona, United States
View Trial DetailsNCT02439775
Cardiovascular Diseases, Hypertension
Huntsville, Alabama, United States
View Trial DetailsNCT07735468
Behavior, Cardiovascular Diseases
Osuna, Sevilla, Spain
View Trial DetailsNCT00837122
Cardiovascular Diseases, Diabetes
Accra, Ghana
View Trial Details