Clinical trial NCT00921791: Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
Official title: Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Blood pressure
Home Blood Pressure Monitoring
Ambulatory Blood Pressure Monitoring
Pharmaceutical care
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Federal University of Health Science of Porto Alegre
First posted: 2009-06-16
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions.

The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).

Detailed description: Home Blood Pressure Monitoring (HBPM) and Pharmaceutical care have been proposed to improve therapeutic compliance and to guide treatment decisions, but their effects on BP control are still under debate.

This is a factorial randomized controlled trial including adult hypertensive patients under drug treatment but with office BP and 24h ABPM uncontrolled. Participants will be allocated to one of four groups: HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; or control. All participants will receive usual care for high blood pressure. Participants will be followed for 60 days.

Eligibility criteria: Inclusion Criteria:

* Office BP ≥140/90 mm Hg
* 24h ABPM hypertension BP ≥130/80 mm Hg
* using at least one antihypertensive drug

Exclusion Criteria:

* BP ≥ 180 / 110 mmHg)
* major cardiovascular events in the last six months
* acute or chronic diseases limiting the capacity to understand and to participate in the trial
* masked hypertension
* white-coat hypertension
* secondary hypertension
* pregnancy
* breastfeeding
* concurrent participation in another trial

Primary outcomes:
measure: Delta values for 24h ABPM between baseline and final ABPM measurements
timeFrame: 60 days
Secondary outcomes:
measure: Hypertension control
timeFrame: 60 days
measure: Average of systolic and diastolic blood pressure at the end of the study.
timeFrame: 60 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Sandra C. Fuchs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuchs SC, Ferreira-da-Silva AL, Moreira LB, Neyeloff JL, Fuchs FC, Gus M, Wiehe M, Fuchs FD. Efficacy of isolated home blood pressure monitoring for blood pressure control: randomized controlled trial with ambulatory blood pressure monitoring - MONITOR study. J Hypertens. 2012 Jan;30(1):75-80. doi: 10.1097/HJH.0b013e32834e5a4f.