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
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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive cardiac failure 629 0
Condition category
Condition code
Cardiovascular 701 701 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of three clinically available beta-blockers (carvedilol, metoprolol succinate, bisoprolol) in cardiac failure.
Intervention code [1] 77 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 854 0
Change in expiratory flow rate
Timepoint [1] 854 0
At 6 weeks
Secondary outcome [1] 1697 0
Change in large arterial function and cardiac chamber function measured by pulse waveform analysis, pulse wave velocity and echocardiography.
Timepoint [1] 1697 0
At 6 weeks.

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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 776 0
Commercial sector/Industry
Name [1] 776 0
Cardiovascular Lipid Grant (Pfizer)
Country [1] 776 0
Primary sponsor type
Individual
Name
Chris Hayward
Address
Country
Secondary sponsor category [1] 642 0
Hospital
Name [1] 642 0
St Vincent's Hospital
Address [1] 642 0
Country [1] 642 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2020 0
Human Research Ethics Committee-St Vincent's Hospital
Ethics committee address [1] 2020 0
Ethics committee country [1] 2020 0
Australia
Date submitted for ethics approval [1] 2020 0
Approval date [1] 2020 0
Ethics approval number [1] 2020 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35301 0
Address 35301 0
Country 35301 0
Phone 35301 0
Fax 35301 0
Email 35301 0
Contact person for public queries
Name 9266 0
Dr Chris Hayward
Address 9266 0
Department of Cardiology
St Vincent's Hospital
Victoria St
Darlinghurst NSW 2010
Country 9266 0
Australia
Phone 9266 0
+61 2 83826880
Fax 9266 0
+61 2 83826881
Email 9266 0
[email protected]
Contact person for scientific queries
Name 194 0
Dr Andrew Jabbour
Address 194 0
Department of Cardiology
St Vincent's Hospital
Victoria St
Darlinghurst NSW 2010
Country 194 0
Australia
Phone 194 0
+61 2 83821111
Fax 194 0
Email 194 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.