Validity of 1BPM for Diagnosis of Hypertension

NCT03147573 | Completed

• 1 other identifier: PI16/00660
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension

Keywords

Hypertension; Blood pressure monitoring

Outcome Measures

Primary Outcomes (4)

• 1-hour blood pressure monitoring

  Blood pressure measurements obtained by 1-hour blood pressure monitoring

  Assessed at 1 study visit (1 hour)

• 24-hour ambulatory blood pressure monitoring

  Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring

  Assessed at 1 day

• Office blood pressure measurement

  Blood pressure measurements obtained by office blood pressure measurement

  Assessed at 3 study visits in two weeks

• Home blood pressure monitoring

  Blood pressure measurements obtained by home blood pressure monitoring

  Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven

Study Arms (1)

Blood pressure monitoring

EXPERIMENTAL

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)

Interventions

1-hour blood pressure monitoring (1BPM) DIAGNOSTIC_TEST

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.

Blood pressure monitoring

24-hour ambulatory blood pressure monitoring (ABPM) DIAGNOSTIC_TEST

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.

Blood pressure monitoring

Office blood pressure measurement (OBPM) DIAGNOSTIC_TEST

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.

Blood pressure monitoring

Home blood pressure monitoring (HBPM) DIAGNOSTIC_TEST

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.

Blood pressure monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Consorci d'Atenció Primària de Salut de l'Eixample: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (3)

Primary Care Center Les Corts

Barcelona, Catalonia, 08028, Spain

Location

Primary Care Center Casanova

Barcelona, Catalonia, 08036, Spain

Location

Primary Care Center Comte Borrell

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (20)

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  PMID: 34654792 DERIVED

• Gonzalez-de Paz L, Kostov B, Alvira-Balada MDC, Colungo C, Garcia N, Roura S, Blat E, Sierra-Benito C, Sotoca-Momblona JM, Benavent-Areu J, Sanchez E, Siso-Almirall A; Eva Sanchez on behalf of the OMBP Group. Effectiveness of a new one-hour blood pressure monitoring method to diagnose hypertension: a diagnostic accuracy clinical trial protocol. BMJ Open. 2019 May 27;9(5):e029268. doi: 10.1136/bmjopen-2019-029268.

  PMID: 31133597 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Antoni Sisó Almirall, MD PhD

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  PRINCIPAL INVESTIGATOR

• Luis González de Paz, PhD

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  STUDY CHAIR

• Belchin Kostov, PhD

  Transversal Group for Research in Primary Care, IDIBAPS

  STUDY CHAIR

• Cristina Sierra Benito, MD PhD

  Hospital Clinic of Barcelona

  STUDY CHAIR

• Josep Miquel Sotoca, PhD

  Hospital Clinic of Barcelona

  STUDY CHAIR

• Mª Carme Alvira, RN

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  STUDY CHAIR

• Cristina Colungo, RN

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  STUDY CHAIR

• Berta de Andrés, RN

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  STUDY CHAIR

• Noemí García, RN

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  STUDY CHAIR

• Silvia Roura, RN

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 10, 2017
• Study Start: June 1, 2017
• Primary Completion: July 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)