Validity of 1BPM for Diagnosis of Hypertension

Summary

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.

Conditions

• Hypertension

Interventions

DIAGNOSTIC_TEST

1-hour blood pressure monitoring (1BPM)

This method consists of performing blood pressure measurements programmed at 5-min intervals over 1 hour. Two extra recordings taken at the start and end of this period are discarded. Blood pressure is measured in a quiet room at the same health centre.

DIAGNOSTIC_TEST

24-hour ambulatory blood pressure monitoring (ABPM)

The device is programmed to record the participant's BP every 20 min and 30 min during the day and night, respectively. Participants are advised to carry on with their normal daily activities, avoiding any intense physical exertion, and to remain at rest when their BP is being measured.

DIAGNOSTIC_TEST

Office blood pressure measurement (OBPM)

Two readings were made one minute apart with a validated automatic sphygmomanometer in a sitting position after five minutes of rest. The average of two readings is calculated. The procedure is repeated during 3 office visits at least a week apart.

DIAGNOSTIC_TEST

Home blood pressure monitoring (HBPM)

For each blood pressure recording, at least two consecutive measurements should be taken, at least one minute apart. Blood pressure should be recorded twice daily, ideally in the morning and evening. Blood pressure recording should continue for at least four consecutive days, ideally seven. The average of the above readings should be calculated, ignoring the first day.

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Consorci d'Atenció Primària de Salut de l'Eixample

  lead OTHER

Principal Investigators

• Antoni Sisó Almirall, MD PhD · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

• Luis González de Paz, PhD · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

• Belchin Kostov, PhD · Transversal Group for Research in Primary Care, IDIBAPS

• Cristina Sierra Benito, MD PhD · Hospital Clinic of Barcelona

• Josep Miquel Sotoca, PhD · Hospital Clinic of Barcelona

• Mª Carme Alvira, RN · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

• Cristina Colungo, RN · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

• Berta de Andrés, RN · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

• Noemí García, RN · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

• Silvia Roura, RN · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2019-07-30

Completion

2019-09-30

Countries

• Spain

Study Locations