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Validity of 1BPM for Diagnosis of Hypertension

Primary Purpose

Hypertension

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

1-hour blood pressure monitoring (1BPM)

24-hour ambulatory blood pressure monitoring (ABPM)

Office blood pressure measurement (OBPM)

Home blood pressure monitoring (HBPM)

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring Hypertension, Blood pressure monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Primary Care Center Les Corts
Primary Care Center Casanova
Primary Care Center Comte Borrell

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood pressure monitoring

Arm Description

Outcomes

Primary Outcome Measures

1-hour blood pressure monitoring

Blood pressure measurements obtained by 1-hour blood pressure monitoring

24-hour ambulatory blood pressure monitoring

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

Office blood pressure measurement

Blood pressure measurements obtained by office blood pressure measurement

Home blood pressure monitoring

Blood pressure measurements obtained by home blood pressure monitoring

Secondary Outcome Measures

Full Information

NCT ID

NCT03147573

First Posted

May 2, 2017

Last Updated

February 28, 2020

Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

Instituto de Salud Carlos III

1. Study Identification

Unique Protocol Identification Number

NCT03147573

Brief Title

Validity of 1BPM for Diagnosis of Hypertension

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

July 30, 2019 (Actual)

Study Completion Date

September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

Instituto de Salud Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Hypertension, Blood pressure monitoring

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blood pressure monitoring

Arm Type

Experimental

Intervention Type

Diagnostic Test

Intervention Name(s)

1-hour blood pressure monitoring (1BPM)

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

24-hour ambulatory blood pressure monitoring (ABPM)

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Office blood pressure measurement (OBPM)

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

Home blood pressure monitoring (HBPM)

Intervention Description

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.

Primary Outcome Measure Information:

Title

1-hour blood pressure monitoring

Description

Blood pressure measurements obtained by 1-hour blood pressure monitoring

Time Frame

Assessed at 1 study visit (1 hour)

Title

24-hour ambulatory blood pressure monitoring

Description

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

Time Frame

Assessed at 1 day

Title

Office blood pressure measurement

Description

Blood pressure measurements obtained by office blood pressure measurement

Time Frame

Assessed at 3 study visits in two weeks

Title

Home blood pressure monitoring

Description

Blood pressure measurements obtained by home blood pressure monitoring

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: