NCT00325832

Brief Summary

To determine if the use of automated office blood pressure readings can improve management of systolic hypertension in routine clinical practice. Automated office SBP recordings in routine clinical practice using the BpTRU device will reflect more accurately the mean awake ambulatory systolic BP than will manual BP readings taken with conventional mercury sphygmomanometry. This should lead to improvements in the management of systolic hypertension with optimization of drug therapy in practices using the BpTRU device.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
Last Updated

August 23, 2010

Status Verified

May 1, 2008

First QC Date

May 12, 2006

Last Update Submit

August 20, 2010

Conditions

Hypertension

Keywords

HypertensionBlood PressureSystolic PressureDiastolic PressureBlood Pressure Monitoring, Ambulatory

Outcome Measures

Primary Outcomes (1)

  • ambulatory blood pressure

Interventions

BpTRUDEVICE
Conventional mercury sphygmomanometryDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Both treated and untreated patients with systolic hypertension under routine FP care
  • For untreated patients, routine office SBP as measured by the patient's FP at the last routine office visit using a mercury device must have SBP ≥ 160 mmHg and DBP \<= 95 mmHg
  • For patients already receiving antihypertensive therapy, the last routine office BP as measured by the patient's FP using mercury sphygmomanometry must be SBP ≥ 140 mmHg and DBP \<= 90 mmHg

You may not qualify if:

  • Presence of target organ damage such as MI, stroke, and serum creatinine twice normal
  • Diabetes mellitus treated with insulin or oral hypoglycemic therapy
  • Secondary hypertension
  • Participation in another research study involving measurement of BP
  • Patient's insistence on using self BP measurement outside of the study
  • Any conditions or circumstances which might preclude the successful completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Myers, MD

    Sunnybrook Medical Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Sheldon Tobe, MD

    Sunnybrook Health Sciences Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

January 1, 2006

Last Updated

August 23, 2010

Record last verified: 2008-05

Locations

CA(1)