Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000735651
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
The BNP Assisted Teatment to Lessen Serial Cardiac Readmissions and Death.
Scientific title
The BNP Assisted Teatment to Lessen Serial Cardiac Readmissions and Death.
Universal Trial Number (UTN)
Trial acronym
The Battle-Scarred Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 887 0
Condition category
Condition code
Cardiovascular 955 955 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive follow up of persons with heart failure, and treatment of heart failure guided by levels of the hormone BNP.

To establish whether intensive follow up of persons admitted to hospital with heart failure, in an out patient clinic setting is more effective than usual follow up. Also, if treatment of heart failure guided by levels of the hormone BNP is better than treatment guided by usual assessment guidelines.
Intervention code [1] 546 0
Treatment: Other
Comparator / control treatment
Usual follow up of persons with heart failure, and treatment of heart failure guided by usual assessment guidelines.
Control group
Placebo

Outcomes
Primary outcome [1] 1255 0
To determine the effect of hormone-guidance of treatment of heart failure on clinical outcomes.
Timepoint [1] 1255 0
Secondary outcome [1] 2287 0
(b) To determine the effect of hormone-guidance of treatment of heart failure on outcomes in subjects <75 years of age.
Timepoint [1] 2287 0
Secondary outcome [2] 2288 0
(c) To determine the effect of standardised regular intensified follow-up on outcomes in heart failure.
Timepoint [2] 2288 0
Secondary outcome [3] 2289 0
(d) To determine the plasma levels and changes in these concentrations over time of Ucn-I and urotensin-II in subjects with heart failure and relate these plasma concentrations to cardiac structure and function and subsequent clinical outcome.
Timepoint [3] 2289 0
Secondary outcome [4] 2290 0
e) To assess the prognostic importance of newer echocardiographic measures of diastolic function in subjects with heart failure and changes in these parameters over time in this population.
Timepoint [4] 2290 0

Eligibility
Key inclusion criteria
Symptomatic congestive HF as defined by Framingham criteria (Table 1), requiring admission to hospital in subjects able to give competent informed consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active myocarditis/pericarditis.Under active consideration for cardiac transplantation. Life expectancy due to non-cardiovascular disease <24 months.Severe hepatic or pulmonary disease (FEV1 <1L).Renal impairment with creatinine at discharge from index admission >0.25mmol/L.Transient HF in association with myocardial infarction treated with acute revascularisation and subsequent ejection fraction during index admission >40%.Severe valvular disease being considered for surgery, or severe aortic stenosis (valve area <1cm2), or symptoms of HF secondary to mitral stenosis.

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)
random permuted blocks
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 212 0
New Zealand
State/province [1] 212 0

Funding & Sponsors
Funding source category [1] 1053 0
Government body
Name [1] 1053 0
Health Research Council of New Zealand
Country [1] 1053 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 914 0
None
Name [1] 914 0
n/a
Address [1] 914 0
Country [1] 914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2352 0
Christchurch
Ethics committee address [1] 2352 0
Ethics committee country [1] 2352 0
New Zealand
Date submitted for ethics approval [1] 2352 0
Approval date [1] 2352 0
Ethics approval number [1] 2352 0

Summary
Brief summary
To establish whether intensive follow up of persons admitted to hospital with heart failure, in an out patient clinic setting is more effective than usual follow up. Also, if treatment of heart failure guided by levels of the hormone BNP is better than treatment guided by usual assessment guidelines.

The three possible treatment groups are:
1. Usual Care Group: Individuals will be followed up via standard health care channels ie GP visits, OP clinic visits.
2. Clinical Group: This group will be reviewed at 3 monthly out patient clinics and a standardised clinical score will be applied to guide treatment regimes.
3. NBNP Group: Also reviewed by the research team at 3 monthly intervals and heart failure treatments are to be guided by NBNP values.

Patients will either continue their health care treatment post discharge via the normal channels, or will be followed up at 3 month intervals, with treatment guided by NBNP levels and/or clinical assessment tools.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36203 0
Address 36203 0
Country 36203 0
Phone 36203 0
Fax 36203 0
Email 36203 0
Contact person for public queries
Name 9735 0
Dr John Lainchbury
Address 9735 0
Cardiology Department
Christchurch Hospital
Private Bag 4710
Christchurch
Country 9735 0
New Zealand
Phone 9735 0
+64 3 3640640
Fax 9735 0
Email 9735 0
[email protected]
Contact person for scientific queries
Name 663 0
Lorraine Skelton
Address 663 0
Department of Medicine
Christchurch School of Medicine & Health Sciences
University of Otago
PO Box 4345
Christchurch
Country 663 0
New Zealand
Phone 663 0
+64 3 3640640
Fax 663 0
+64 3 3641115
Email 663 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4207Study results articleYes n/a

Documents added automatically
No additional documents have been identified.