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Completed

NCT Number: NCT03147573

Validity of 1BPM 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Center Casanova, Barcelona, Catalonia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. 1-hour blood pressure monitoring

    Time frame: Assessed at 1 study visit (1 hour)

    Blood pressure measurements obtained by 1-hour blood pressure monitoring

  2. 24-hour ambulatory blood pressure monitoring

    Time frame: Assessed at 1 day

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

  3. Office blood pressure measurement

    Time frame: Assessed at 3 study visits in two weeks

    Blood pressure measurements obtained by office blood pressure measurement

  4. 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

Sponsors and collaborators

Lead sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 10, 2017
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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