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

This study is currently recruiting participants.
Verified by Sunnybrook Health Sciences Centre, May 2008

Sponsors and Collaborators: Sunnybrook Health Sciences Centre
Heart and Stroke Foundation of Ontario
Information provided by: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00325832
  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 IV

MedlinePlus related topics:   High Blood Pressure    Mercury   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Open Label, Active Control, Factorial Assignment

Further study details as provided by Sunnybrook Health Sciences Centre:

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

Contacts
Contact: Martin Myers, MD     416-480-6100 ext 4927     martin.myers@sunnybrook.ca    

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre     Recruiting
      Toronto, Ontario, Canada, M4N 3M5
      Sub-Investigator: Sheldon Tobe, MD            
      Principal Investigator: Martin Myers, MD            

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


Study ID Numbers:   392-2005
First Received:   May 12, 2006
Last Updated:   May 21, 2008
ClinicalTrials.gov Identifier:   NCT00325832
Health Authority:   Canada: Ethics Review Committee

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

Study placed in the following topic categories:
Vascular Diseases
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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