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ISRCTN
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ISRCTN12912185
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ClinicalTrials.gov identifier
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Public title
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Conventional Versus Automated Measurement of Blood Pressure in the Office
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Scientific title
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Acronym
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The CAMBO Study
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Serial number at source
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392-2005
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Study hypothesis
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Automated office systolic blood pressure (SBP) recordings in routine clinical practice using the BpTRU device will reflect more accurately the mean awake ambulatory systolic blood pressure (BP) than 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.
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Lay summary
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Ethics approval
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Approved by the Sunnybrook Research Ethics Board (REB) on 20/10/2005, reference number: 392-2005
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Study design
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A cluster randomized, controlled, clinical trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Systolic hypertension
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Participants - inclusion criteria
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Both treated and untreated patients with systolic hypertension under routine family physician (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 diastolic blood pressure (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.
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Participants - exclusion criteria
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1. Presence of target organ damage such as myocardial infarction (MI), stroke, and serum creatinine twice the upper limit of normal
2.Diabetes mellitus treated with insulin or oral hypoglycemic therapy
3. Secondary hypertension
4. Participation in another research study involving measurement of BP
5. Patient's insistence on using self BP measurement outside of the study
6. Any conditions or circumstances which might preclude the successful completion of the study
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Anticipated start date
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15/01/2006
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Anticipated end date
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15/01/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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Measurement of blood pressure using automated office BP with a target of 135 mmHg versus office mercury sphygmomanometer with a target of 140 mmHg
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Primary outcome measure(s)
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Differences in SBP between the mean awake ambulatory BP and the manual office BP versus the difference in SBP between the mean awake ambulatory BP and the automated office BP
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Secondary outcome measure(s)
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1. Differences in SBP between the mean awake 24-hour ambulatory BP and the manual office BP versus the automated BP
2. Differences in SBP between the mean nocturnal ambulatory BP and the manual office BP versus the automated BP
3. Differences in coefficients of correlation (r value) between the awake ambulatory BP and the manual versus automated office BP
4. Differences in the coefficients of correlation between the manual office SBP versus the automated BP versus the mean awake, 24-hour or nocturnal ambulatory SBP
5. Differences in the primary outcome between men and women
6. Adverse effects related to management of hypertension with manual versus automated BP
7. Differences in intensity of drug therapy for manual versus automated office BP patients
8. Frequency of medication changes for manual versus automated office BP patients
9. Cost of drug therapy at year two for manual versus automated office BP patients
10. Clinical events of serious adverse events reported for manual versus automated office BP patients
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Sources of funding
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Heart and Stroke Foundation of Ontario
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Trial website
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Publications
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Contact name
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Dr
Martin
Myers
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Address
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2075 Bayview Avenue
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City/town
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Toronto
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Zip/Postcode
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M4N 3M5
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Country
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Canada
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Email
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martin.myers@sunnybrook.ca
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Sponsor
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Heart and Stroke Foundation of Ontario (Canada)
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Address
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1920 Yonge Street
Fourth Floor
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City/town
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Toronto
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Zip/Postcode
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M4S 3E2
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Country
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Canada
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Email
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efreeman@hsf.on.ca
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Date applied
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11/05/2006
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Last edited
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19/06/2006
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Date ISRCTN assigned
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19/06/2006
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