Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000733673
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
11/11/2005
Date last updated
11/11/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The PRO-BNP Evaluation (PROBE) Study
Scientific title
Do Plasma Pro-BNP Levels Measured Prior to Discharge Alter Management and Outcomes in Patients Admitted with Heart Failure? A Randomised Controlled Trial.
Universal Trial Number (UTN)
Trial acronym
PROBE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 885 0
Condition category
Condition code
Cardiovascular 953 953 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to BNP group. For the BNP group, the proBNP result will be given to the physician responsible for the patient's care prior to discharge. The report with proBNP result will include an interpretative statement based on the known prognostic value of BNP levels to predict rehospitalisation and death from heart failure.

Three hundred (300) patients admitted to hospital with clinical heart failure as a primary diagnosis and not enrolled in other studies will be eligible for inclusion.
Eligible patients will be approached at day 4 of admission to hospital, once initial stabilisation has occurred and prior to hospital discharge. If written informed consent is obtained the patients will provide a blood sample for proBNP levels.

Clinical follow-up will then be collected on all patients by phone call to patient, physician and GP at 180 and 360 days. Mortality data will be confirmed from the Births, Deaths and Marriages register. Hospitalisation will be confirmed from the Patient Management System and clinical record.
Intervention code [1] 475 0
Other interventions
Comparator / control treatment
Patients randomised to no-BNP group. For the No-BNP group, proBNP levels will not be given to the physician responsible for the patient's care.

Three hundred (300) patients admitted to hospital with clinical heart failure as a primary diagnosis and not enrolled in other studies will be eligible for inclusion.
Eligible patients will be approached at day 4 of admission to hospital, once initial stabilisation has occurred and prior to hospital discharge. If written informed consent is obtained the patients will provide a blood sample for proBNP levels.

Clinical follow-up will then be collected on all patients by phone call to patient, physician and GP at 180 and 360 days. Mortality data will be confirmed from the Births, Deaths and Marriages register. Hospitalisation will be confirmed from the Patient Management System and clinical record.
Control group
Placebo

Outcomes
Primary outcome [1] 1252 0
Rate of all cause mortality
Timepoint [1] 1252 0
At 180 days
Primary outcome [2] 1253 0
Readmission for heart failure
Timepoint [2] 1253 0
At 180 days
Secondary outcome [1] 2279 0
Pre-specified subgroup analysis of the primary endpoint based on tertiles of pro-BNP level.
Timepoint [1] 2279 0
At baseline.
Secondary outcome [2] 2280 0
Duration of initial hospitalisation.
Timepoint [2] 2280 0
Secondary outcome [3] 2281 0
Mortality (all cause and cardiac).
Timepoint [3] 2281 0
At 30, 90 and 180 days.
Secondary outcome [4] 2282 0
Re-hospitalisation (all cause, HF and cardiac).
Timepoint [4] 2282 0
At 30, 90 and 180 days.
Secondary outcome [5] 2283 0
Medication rates (achieved doses of established medications).
Timepoint [5] 2283 0
At discharge of index admission and at end of follow-up.
Secondary outcome [6] 2284 0
Rates of referral to HF clinic / outreach services.
Timepoint [6] 2284 0

Eligibility
Key inclusion criteria
Admitted with clinical heart failure (Framingham criteria).
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to consent- Enrolment in other trials- Not residing locally- Acute coronary syndrome, if LVEF is >40% and/or the patient is revascularised- Severe stenotic valvular disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
computerised
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 204 0
New Zealand
State/province [1] 204 0

Funding & Sponsors
Funding source category [1] 1051 0
Commercial sector/Industry
Name [1] 1051 0
Roche
Country [1] 1051 0
Primary sponsor type
Commercial sector/Industry
Name
Roche
Address
Country
Switzerland
Secondary sponsor category [1] 912 0
University
Name [1] 912 0
Christchurch Cardioendocrine Research Group
Address [1] 912 0
Country [1] 912 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2351 0
Christchurch
Ethics committee address [1] 2351 0
Ethics committee country [1] 2351 0
New Zealand
Date submitted for ethics approval [1] 2351 0
Approval date [1] 2351 0
Ethics approval number [1] 2351 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35742 0
Address 35742 0
Country 35742 0
Phone 35742 0
Fax 35742 0
Email 35742 0
Contact person for public queries
Name 9664 0
Dr Richard Troughton
Address 9664 0
Christchurch Cardioendocrine Research Group
Department of Medicine
Christchurch School of Medicine & Health Sciences
University of Otago
PO Box 4345
Christchurch 8015
Country 9664 0
New Zealand
Phone 9664 0
+64 3 3640640
Fax 9664 0
+64 3 3641115
Email 9664 0
[email protected]
Contact person for scientific queries
Name 592 0
Lorraine Skelton
Address 592 0
Christchurch Cardioendocrine Research Group
Department of Medicine
Christchurch School of Medicine & Health Sciences
University of Otago
PO Box 4345
Christchurch 8015
Country 592 0
New Zealand
Phone 592 0
+64 3 3641063
Fax 592 0
+64 3 3641115
Email 592 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
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