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Trial registered on ANZCTR
Registration number
ACTRN12605000504617
Ethics application status
Approved
Date submitted
28/07/2005
Date registered
26/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered
Titles & IDs
Public title
beta blockers and lung function in heart failure
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Scientific title
Comparison of non-selective and beta1-selective beta-blockers on respiratory and arterial function and cardiac chamber dynamics in patients with chronic stable congestive cardiac failure
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Congestive cardiac failure
629
0
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Condition category
Condition code
Cardiovascular
701
701
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Comparison of three clinically available beta-blockers (carvedilol, metoprolol succinate, bisoprolol) in cardiac failure.
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Intervention code [1]
77
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Treatment: Drugs
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Comparator / control treatment
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Control group
Active
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Outcomes
Primary outcome [1]
854
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Change in expiratory flow rate
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Assessment method [1]
854
0
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Timepoint [1]
854
0
At 6 weeks
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Secondary outcome [1]
1697
0
Change in large arterial function and cardiac chamber function measured by pulse waveform analysis, pulse wave velocity and echocardiography.
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Assessment method [1]
1697
0
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Timepoint [1]
1697
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At 6 weeks.
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Eligibility
Key inclusion criteria
Stable NYHA Class I, II, III CCF pts already receiving beta-blocker therapy. Half of study population to have defined (on basis of RFT testing) or treated airways disease.
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Minimum age
Not stated
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Maximum age
Not stated
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random allocation sequence was implemented by allocating a beta blocker according to the numeral generated by a random number generator. If a patient was initially on carvedilol then an even number would prompt a change to metoprolol and an odd number a change to bisoprolol. If a patient was initially on metoprolol, an even number would prompt a change to bisoprolol and an odd number a change to carvedilol. If a pateint was initially on bisoprolol, an even number would prompt a change to carvedilol and an odd number a change to metoprolol. The next change of beta blocker would simply be to the last of the 3 beta blockers in the study. This sequence was concealed until the interventions were assigned.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number was generated by using an internet based random number generator at http://www.randomizer.org/form.htm .The stratification is outlined in the previous answer to allocation concealment.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/07/2005
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
776
0
Commercial sector/Industry
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Name [1]
776
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Cardiovascular Lipid Grant (Pfizer)
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Address [1]
776
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Country [1]
776
0
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Primary sponsor type
Individual
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Name
Chris Hayward
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Address
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Country
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Secondary sponsor category [1]
642
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Hospital
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Name [1]
642
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St Vincent's Hospital
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Address [1]
642
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Country [1]
642
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
2020
0
Human Research Ethics Committee-St Vincent's Hospital
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Ethics committee address [1]
2020
0
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Ethics committee country [1]
2020
0
Australia
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Date submitted for ethics approval [1]
2020
0
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Approval date [1]
2020
0
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Ethics approval number [1]
2020
0
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Summary
Brief summary
This study will compare 3 beta blocker tablets routinely used in treating patients with heart failure. There are theoretical reasons for differences between the tablets (particularly with respect to lung function and blood pressure changes), although this has not been tested in head-to-head comparison.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35301
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Address
35301
0
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Country
35301
0
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Phone
35301
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Fax
35301
0
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Email
35301
0
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Contact person for public queries
Name
9266
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Dr Chris Hayward
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Address
9266
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Department of Cardiology
St Vincent's Hospital
Victoria St
Darlinghurst NSW 2010
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Country
9266
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Australia
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Phone
9266
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+61 2 83826880
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Fax
9266
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+61 2 83826881
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Email
9266
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[email protected]
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Contact person for scientific queries
Name
194
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Dr Andrew Jabbour
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Address
194
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Department of Cardiology
St Vincent's Hospital
Victoria St
Darlinghurst NSW 2010
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Country
194
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Australia
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Phone
194
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+61 2 83821111
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Fax
194
0
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Email
194
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[email protected]
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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.
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