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Conventional Versus Automated Measurement of Blood Pressure in the Office (The CAMBO Study)

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00325832
First received: May 12, 2006
Last updated: August 20, 2010
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Device: BpTRU
Device: Conventional mercury sphygmomanometry
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • ambulatory blood pressure

Estimated Enrollment: 750
Study Start Date: January 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325832

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Martin Myers, MD Sunnybrook Medical Sciences Centre
Study Chair: Sheldon Tobe, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325832     History of Changes
Other Study ID Numbers: 392-2005
Study First Received: May 12, 2006
Last Updated: August 20, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Hypertension
Blood Pressure
Systolic Pressure
Diastolic Pressure
Blood Pressure Monitoring, Ambulatory

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013