Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000736640
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
11/11/2005
Date last updated
11/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
DETECTION OF EARLY CARDIAC (ASYMPTOMATIC) DISEASE BY B-TYPE NATRIURETIC PEPTIDE (DETECT STUDY).
Scientific title
DETECTION OF EARLY CARDIAC (ASYMPTOMATIC) DISEASE BY B-TYPE NATRIURETIC PEPTIDE (DETECT STUDY).
Universal Trial Number (UTN)
Trial acronym
DETECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Cardiac Disease 888 0
Condition category
Condition code
Cardiovascular 956 956 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None.
Intervention code [1] 554 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1256 0
To test the ability of plasma NT-proBNP and/or BNP to distinguish early structural and/or functional cardiac changes (including increased left ventricular mass and abnormal diastolic function) in asymptomatic groups at risk of later adverse cardiac outcomes.
Timepoint [1] 1256 0
Secondary outcome [1] 2291 0
Timepoint [1] 2291 0

Eligibility
Key inclusion criteria
Study Population: Fifty asymptomatic patients aged 45-65 years with treated or untreated hypertension of 10 or more years duration any of whom may or may not have additional risk factors, including diabetes, dyslipidaemia, obesity. No patient will have incurred any overt cardiovascular event (ie. no acute coronary syndrome, no stable angina, no heart failure, no cerebrovascular events and no peripheral arterial events).Control Group: Fifty age, gender and BMI-matched unmedicated controls with no history of cardiovascular risk factors or events and with normal findings on physical examination. Both groups will have normal renal function.
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 215 0
New Zealand
State/province [1] 215 0

Funding & Sponsors
Funding source category [1] 1054 0
Commercial sector/Industry
Name [1] 1054 0
Roche Diagnostics
Country [1] 1054 0
Primary sponsor type
Commercial sector/Industry
Name
Roche Diagnostics
Address
Country
Switzerland
Secondary sponsor category [1] 915 0
University
Name [1] 915 0
Christchurch Cardioendocrine Research Group
Address [1] 915 0
Country [1] 915 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2353 0
Christchurch
Ethics committee address [1] 2353 0
Ethics committee country [1] 2353 0
New Zealand
Date submitted for ethics approval [1] 2353 0
Approval date [1] 2353 0
Ethics approval number [1] 2353 0

Summary
Brief summary
This is a pilot study to test the ability of the heart hormones plasma NT-proBNP and/or BNP to distinguish early structural and/or functional cardiac changes in asymptomatic subjects at risk of later adverse cardiac outcomes.
100 people in all will be invited to take part. Fifty will be asymptomatic, aged 45-65 years with treated or untreated hypertension of 10 or more years duration any of whom may or may not have additional risk factors, including diabetes, dyslipidaemia, obesity. None of these subjects will have any overt cardiovascular medical history. The other fifty people will be age, gender and BMI-matched unmedicated controls with no history of cardiovascular risk factors or events and with normal findings on physical examination. Both groups will have normal renal function.

All participants will be asked to attend one outpatient clinic for:
Full medical history.
Physical examination including full cardiovascular examination and recording of age, gender, height, weight, waist circumference, heart rate, blood pressure, heart sounds and venous pressure.
Recording of any medications.
Routine haematology, biochemistry including haemoglobin, white cell count, creatinine, Na, K, fasting sugar and lipid profile.
Echocardiography with full assessment of dimensions and both systolic and diastolic function.
Blood sampling for plasma BNP and NT-proBNP

A second attendance will be required for a Cardiac magnetic resonance scanning to measure left ventricular mass will be performed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35917 0
Address 35917 0
Country 35917 0
Phone 35917 0
Fax 35917 0
Email 35917 0
Contact person for public queries
Name 9743 0
Dr Richard Troughton
Address 9743 0
Department of Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8015
Country 9743 0
New Zealand
Phone 9743 0
+64 3 3640640
Fax 9743 0
+64 3 3641115
Email 9743 0
[email protected]
Contact person for scientific queries
Name 671 0
Lorraine Skelton
Address 671 0
Department of Medicine
Christchurch School of Medicine & Health Sciences
PO Box 4345
Christchurch 8015
Country 671 0
New Zealand
Phone 671 0
+64 3 3640640
Fax 671 0
+64 3 3641115
Email 671 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.