Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000144516
Ethics application status
Approved
Date submitted
11/04/2006
Date registered
27/04/2006
Date last updated
27/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
B-type natriuretic peptide (BNP) infusions and ventricular remodelling in acute myocardial infarction
Scientific title
A randomised study of placebo or B-type natriuretic peptide (BNP) in acute myocardial infarction to assess the potential effect on ventricular remodelling, neurohormonal status and cardiovascular outcomes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myocardial Infarction 1113 0
Condition category
Condition code
Cardiovascular 1193 1193 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
60 hours of infused BNP at a dose of 0.010g/kg/minute.
Intervention code [1] 978 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1612 0
Patients will undergo detailed echocardiography characterising systolic and diastolic function including recently validated, load independent diastolic parameters (tissue Doppler imaging and colour M-mode flow propagation velocity).
Timepoint [1] 1612 0
Daily for the first 5 days post-infarction. Post-discharge echocardiography will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [2] 1613 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the cardiac natriuretic peptides
Timepoint [2] 1613 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [3] 1614 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the angiotensin II
Timepoint [3] 1614 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [4] 1615 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the aldosterone
Timepoint [4] 1615 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [5] 1616 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the endothelin
Timepoint [5] 1616 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [6] 1617 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the plasma catecholamines
Timepoint [6] 1617 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [7] 1618 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the adrenomedullin
Timepoint [7] 1618 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [8] 1619 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the aminoterminal CNP
Timepoint [8] 1619 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [9] 1620 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the urocortin
Timepoint [9] 1620 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Primary outcome [10] 1621 0
The plasma neurohormonal profile will be obtained with venous blood sampled for measurement of the urotensin II
Timepoint [10] 1621 0
Daily for the first 5 days post-infarction. Neurohormonal sampling will be repeated at one month and again at 3 months after the onset of myocardial infarction.
Secondary outcome [1] 2908 0
Assess the potential benefit of infused low dose B-type natriuretic peptide (BNP) on ventricular remodelling, neurohormonal status and cardiovascular outcomes.
Timepoint [1] 2908 0
Over the 3 months post-infarction.

Eligibility
Key inclusion criteria
Who have completed acute myocardial infarction confirmed by typical clinical presentation, ischaemic ECG changes (including ST elevation) and definite rise and evolving pattern of cardiac markers indicative of failed early perfusion, LV regional wall motion abnormality. Patients will be enrolled within 12-48 hours after the onset of symptoms. At the time of initiation of placebo or BNP infusions, blood pressure is to be >100 mmHg systolic and heart rate < 100 bpm.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent, unavailability of follow-up, evolving shock, unstable cardiac rhythm, haemodynamic parameters that fall outside those listed in the inclusion criteria.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was at a central administration by telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and therapists are blinded in this study
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2003
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] 299 0
New Zealand
State/province [1] 299 0

Funding & Sponsors
Funding source category [1] 1307 0
Government body
Name [1] 1307 0
Health Research Council
Country [1] 1307 0
Primary sponsor type
Government body
Name
Health Research Council
Address
Country
Secondary sponsor category [1] 1154 0
University
Name [1] 1154 0
Christchurch Cardioendocrine Research Group
Address [1] 1154 0
Country [1] 1154 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2635 0
Christchurch Hospital
Ethics committee address [1] 2635 0
Ethics committee country [1] 2635 0
New Zealand
Date submitted for ethics approval [1] 2635 0
Approval date [1] 2635 0
28/02/2002
Ethics approval number [1] 2635 0
CTY/02/02/017

Summary
Brief summary
Myocardial infarction remains common and early sequelae include adverse heart function, decompensation and increased death particularly over the first 3 months after a heart attack. This study aims to: (1) provide detailed information regarding early changes in heart function and hormones in patients who suffer heart attacks and do not have a successful early intervention to restore normal blood flow to the heart .(2) assess the potential benefit of infused BNP hormone on heart function, hormone status and cardiovascular outcomes over the 3 months following a heart attack.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36172 0
Address 36172 0
Country 36172 0
Phone 36172 0
Fax 36172 0
Email 36172 0
Contact person for public queries
Name 10167 0
Lorraine Skelton
Address 10167 0
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 10167 0
New Zealand
Phone 10167 0
+64 3 3641063
Fax 10167 0
+64 3 3641115
Email 10167 0
[email protected]
Contact person for scientific queries
Name 1095 0
Lorraine Skelton
Address 1095 0
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 1095 0
New Zealand
Phone 1095 0
+64 3 3641063
Fax 1095 0
+64 3 3641115
Email 1095 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.