Condition category
Circulatory System
Date applied
11/05/2006
Date assigned
19/06/2006
Last edited
19/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Myers

ORCID ID

Contact details

2075 Bayview Avenue
Toronto
M4N 3M5
Canada
martin.myers@sunnybrook.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

392-2005

Study information

Scientific title

Acronym

The CAMBO Study

Study hypothesis

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.

Ethics approval

Approved by the Sunnybrook Research Ethics Board (REB) on 20/10/2005, reference number: 392-2005

Study design

A cluster randomized, controlled, clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Condition

Systolic hypertension

Intervention

Measurement of blood pressure using automated office BP with a target of 135 mmHg versus office mercury sphygmomanometer with a target of 140 mmHg

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

15/01/2006

Overall trial end date

15/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

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

Recruitment start date

15/01/2006

Recruitment end date

15/01/2008

Locations

Countries of recruitment

Canada

Trial participating centre

2075 Bayview Avenue
Toronto
M4N 3M5
Canada

Sponsor information

Organisation

Heart and Stroke Foundation of Ontario (Canada)

Sponsor details

1920 Yonge Street
Fourth Floor
Toronto
M4S 3E2
Canada
efreeman@hsf.on.ca

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Heart and Stroke Foundation of Ontario

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes