Validity of 1BPM for Diagnosis of Hypertension

Consorci d'Atenció Primària de Salut de l'Eixample

Status: Completed

Conditions: Hypertension

Treatments: Diagnostic Test: 1-hour blood pressure monitoring (1BPM); Diagnostic Test: Home blood pressure monitoring (HBPM); Diagnostic Test: Office blood pressure measurement (OBPM); Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03147573

PI16/00660

Details and patient eligibility

About

Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension.

Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age > 18 years
• To visit routinely in the health centres where the study is carried out

Exclusion criteria

• Severe physical or cognitive limitations
• Atrial fibrillation or other heart rhythm disorders that could interfere with readings
• Arm Circumference > 42cm
• Arm with arteriovenous fistula
• Mental disorders
• Intolerance to the method of measurement
• Hospitalization during the study period

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Blood pressure monitoring

Experimental group

Treatment:

Diagnostic Test: Office blood pressure measurement (OBPM)

Diagnostic Test: Home blood pressure monitoring (HBPM)

Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM)

Diagnostic Test: 1-hour blood pressure monitoring (1BPM)