Validity of 1BPM for Diagnosis of Hypertension

Not Applicable

Completed

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

• Registration Number: NCT03147573
• Lead Sponsor: Consorci d'Atenció Primària de Salut de l'Eixample

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Study Start: 2017-06-01
• Primary Completion: 2019-07-30
• Study Completion: 2019-09-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood pressure monitoring	24-hour ambulatory blood pressure monitoring (ABPM)	-
Blood pressure monitoring	1-hour blood pressure monitoring (1BPM)	-
Blood pressure monitoring	Office blood pressure measurement (OBPM)	-
Blood pressure monitoring	Home blood pressure monitoring (HBPM)	-

Primary Outcome Measures

Name	Time	Method
1-hour blood pressure monitoring	Assessed at 1 study visit (1 hour)	Blood pressure measurements obtained by 1-hour blood pressure monitoring
24-hour ambulatory blood pressure monitoring	Assessed at 1 day	Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring
Office blood pressure measurement	Assessed at 3 study visits in two weeks	Blood pressure measurements obtained by office blood pressure measurement
Home blood pressure monitoring	Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven	Blood pressure measurements obtained by home blood pressure monitoring

Trial Locations

Locations (3)

Primary Care Center Casanova; 🇪🇸 Barcelona, Catalonia, Spain

Primary Care Center Les Corts; 🇪🇸 Barcelona, Catalonia, Spain

Primary Care Center Comte Borrell; 🇪🇸 Barcelona, Catalonia, Spain