Australian New Zealand Clinical Trials Registry

Trial Details

indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.

Request Number:

000623

ACTR Number:

ACTRN12605000735651

Trial Status:

Registered

Date Submitted:

13/09/2005

Date Registered:

11/11/2005

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Public title:

The BNP Assisted Teatment to Lessen Serial Cardiac Readmissions and Death.

ANZCTR registration title:

The BNP Assisted Teatment to Lessen Serial Cardiac Readmissions and Death.

Secondary ID:

UTN:

Trial acronym:

The Battle-Scarred Study

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Health condition(s) or problem(s) studied:
Heart Failure

Cardiovascular	Other cardiovascular diseases
Condition category:	Condition code:

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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:

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

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Primary outcome:	To determine the effect of hormone-guidance of treatment of heart failure on clinical outcomes.
Timepoint:
Secondary outcome 1:	(b) To determine the effect of hormone-guidance of treatment of heart failure on outcomes in subjects <75 years of age.
Timepoint:
Secondary outcome 2:	(c) To determine the effect of standardised regular intensified follow-up on outcomes in heart failure.
Timepoint:
Secondary outcome 3:	(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:
Secondary outcome 4:	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:

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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

Gender:

Both males and females

Healthy volunteers?

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.

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Study type:

Interventional

Purpose of the study:

Treatment

Allocation to intervention:

Randomised controlled trial

Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):

random permuted blocks

Describe the 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:

Assignment:

Parallel

Other design features (specify):

Type of endpoint(s):

Safety/efficacy

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Phase

Anticipated or actual date of first participant enrolement:

1/01/2001

Target sample size:

1000

Recruitment status:

Open to recruitment

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Funding source:

Government funding body e.g. Australian Research Council

Name:

Health Research Council of New Zealand

Address:

Country:

New Zealand

Primary sponsor:

Government funding body e.g. Department of Health

Name:

Health Research Council of New Zealand

Address:

Country:

New Zealand

Secondary sponsor:

None

Name:

n/a

Address:

Country:

Other collaborator:

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Has the study received approval from at least one ethics committee?

Yes

Ethics Committee name:

Christchurch

Address:

Country:

New Zealand

Date of approval:

HREC Number:

Countries of recruitment:

Outside Australia

New Zealand

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:

Presentations / publication list:

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Contact person for public queries

Name:

Dr John Lainchbury

Address:

Cardiology Department Christchurch Hospital Private Bag 4710 Christchurch

Country:

New Zealand

Tel:

+64 3 3640640

Fax:

Email:

john.lainchbury@cdhb.govt.nz

Contact person for scientific queries

Name:

Lorraine Skelton

Address:

Department of Medicine Christchurch School of Medicine & Health Sciences University of Otago PO Box 4345 Christchurch

Country:

New Zealand

Tel:

+64 3 3640640

Fax:

+64 3 3641115

Email:

lorraine.skelton@cdhb.govt.nz

Contact person responsible for updating information

Name:

Address:

Country:

Tel:

Fax:

Email:

Trial Details

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