Validity of 1BPM for Diagnosis of Hypertension

February 28, 2020 updated by: Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample

Validity of 1-hour Blood Pressure Monitoring Against the Usual Methods for Diagnosis of Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08028
        • Primary Care Center Les Corts
      • Barcelona, Catalonia, Spain, 08036
        • Primary Care Center Casanova
      • Barcelona, Catalonia, Spain, 08036
        • Primary Care Center Comte Borrell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Blood pressure monitoring
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Antoni Sisó Almirall, MD PhD, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
  • Study Chair: 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

July 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (ACTUAL)

May 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI16/00660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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