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

First Received: May 12, 2006 Last Updated: May 21, 2008 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Mercury

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	392-2005
Study First Received:	May 12, 2006
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00325832 History of Changes
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:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009