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Clinical Trials/NCT00921791
NCT00921791
Completed
Not Applicable

Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement

Hospital de Clinicas de Porto Alegre1 site in 1 country136 target enrollmentApril 2006
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
136
Locations
1
Primary Endpoint
Delta values for 24h ABPM between baseline and final ABPM measurements
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2006
End Date
June 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Delta values for 24h ABPM between baseline and final ABPM measurements

Time Frame: 60 days

Secondary Outcomes

  • Hypertension control(60 days)
  • Average of systolic and diastolic blood pressure at the end of the study.(60 days)

Study Sites (1)

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