Clinical trial NCT03147573: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Blood pressure monitoring
Lead sponsor: Consorci d'Atenció Primària de Salut de l'Eixample
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2017-05-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: 1-hour blood pressure monitoring
timeFrame: Assessed at 1 study visit (1 hour)
measure: 24-hour ambulatory blood pressure monitoring
timeFrame: Assessed at 1 day
measure: Office blood pressure measurement
timeFrame: Assessed at 3 study visits in two weeks
measure: Home blood pressure monitoring
timeFrame: Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Primary Care Center Les Corts
state: Catalonia
city: Barcelona
country: Spain
facility: Primary Care Center Casanova
state: Catalonia
city: Barcelona
country: Spain
facility: Primary Care Center Comte Borrell
state: Catalonia
Study officials:
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Antoni Sisó Almirall, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Luis González de Paz, PhD
role: STUDY_CHAIR
affiliation: Transversal Group for Research in Primary Care, IDIBAPS
name: Belchin Kostov, PhD
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Cristina Sierra Benito, MD PhD
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Josep Miquel Sotoca, PhD
role: STUDY_CHAIR
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Mª Carme Alvira, RN
role: STUDY_CHAIR
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Cristina Colungo, RN
role: STUDY_CHAIR
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Berta de Andrés, RN
role: STUDY_CHAIR
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Noemí García, RN
role: STUDY_CHAIR
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Silvia Roura, RN
role: STUDY_CHAIR
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