Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000491460
Ethics application status
Approved
Date submitted
11/04/2016
Date registered
14/04/2016
Date last updated
22/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Beta Blocker Intolerance: Genetic Testing to Explain Side Effects
Scientific title
Beta Receptor Polymorphism and Intolerance to Beta Blockade in Patients with Heart Failure or Ischaemic Heart Disease
Secondary ID [1] 288970 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 298357 0
Ischaemic Heart Disease 298358 0
Beta Blocker Intolerance 298382 0
Condition category
Condition code
Cardiovascular 298466 298466 0 0
Other cardiovascular diseases
Cardiovascular 298468 298468 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with heart failure or ischaemic heart disease plus a history of intolerance to beta blockers (e.g. metoprolol) will have their blood samples taken. DNA analysis will be conducted to determine if beta receptor polymorphisms are associated with intolerance to this class of medicine.
Intervention code [1] 294457 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will be a set of patients with heart failure or ischaemic heart disease, but are tolerant to beta blockers.
Control group
Active

Outcomes
Primary outcome [1] 297956 0
Incidence of beta-1 receptor polymorphisms. This will be assessed by analysing the DNA of blood samples.
Timepoint [1] 297956 0
After DNA analysis is complete for all participants
Primary outcome [2] 297966 0
Incidence of beta-2 receptor polymorphisms. This will be assessed by analysing the DNA of blood samples.
Timepoint [2] 297966 0
After DNA analysis is complete for all participants
Secondary outcome [1] 322762 0
Comparative doses of beta blockers via review of patient medical records
Timepoint [1] 322762 0
After recruitment is complete

Eligibility
Key inclusion criteria
Systolic Heart Failure NYHA II-IV or Ischaemic Heart Disease
At least one documented dose of beta blocker
Documented intolerance to beta blocker (cases) - wheeze / bradycardia
Documented tolerance to beta blockers (controls)
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diastolic Heart Failure
Hypertrophic Cardiomyopathy
Renal / Hepatic Failure

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Retrospective
Statistical methods / analysis
The incidence of particular receptor mutations will be compared between the cases and controls. Programs such as Microsoft Excel or SPSS will be used to perform the statistical analysis. T-test will be utilised to detect a significant difference.

Sample Size
The target sample size is 200. We assume that the participation rate will be as low as 65%, therefore we will endeavour to identify 300 candidates (150 cases + 150 controls) to assure a test population of 200

Power
With the target sample size of 200, we will have 80% power to detect a difference in receptor incidence of 20% or more.

Example of calculation parameters (http://clincalc.com/Stats/SampleSize.aspx)

Two independent study groups
The Primary Endpoint is dichotomous
Type I error 0.05
Beta-1 incidence in controls assumed to be 15% (expected incidence in general population)
Beta-1 incidence in cases assumed to be 35% in this example
Power to detect such a difference is 80%

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2016
Actual
1/09/2016
Date of last participant enrolment
Anticipated
30/04/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5590 0
Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors
Funding source category [1] 293328 0
University
Name [1] 293328 0
University of Western Australia
Country [1] 293328 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Medicine and Pharmacology, University of Western Australia, M503. 35 Stirling Hwy. Nedlands, W.A. 6009
Country
Australia
Secondary sponsor category [1] 292145 0
Hospital
Name [1] 292145 0
Sir Charles Gairdner Hospital
Address [1] 292145 0
Monash Ave, Nedlands. W.A. 6009
Country [1] 292145 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294797 0
Sir Charles Gairdner Human Research Ethics Committee
Ethics committee address [1] 294797 0
Ethics committee country [1] 294797 0
Australia
Date submitted for ethics approval [1] 294797 0
29/03/2016
Approval date [1] 294797 0
08/08/2016
Ethics approval number [1] 294797 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65082 0
Dr Brendan McQuillan
Address 65082 0
School of Medicine and Pharmacology, University of Western Australia, M503. 35 Stirling Hwy. Crawley, W.A. 6009.
Country 65082 0
Australia
Phone 65082 0
+61 8 6151 0834
Fax 65082 0
Email 65082 0
[email protected]
Contact person for public queries
Name 65083 0
Brendan McQuillan
Address 65083 0
School of Medicine and Pharmacology, University of Western Australia, M503. 35 Stirling Hwy. Crawley, W.A. 6009.
Country 65083 0
Australia
Phone 65083 0
+61 8 6151 0834
Fax 65083 0
Email 65083 0
[email protected]
Contact person for scientific queries
Name 65084 0
Brendan McQuillan
Address 65084 0
School of Medicine and Pharmacology, University of Western Australia, M503. 35 Stirling Hwy. Crawley, W.A. 6009.
Country 65084 0
Australia
Phone 65084 0
+61 8 6151 0834
Fax 65084 0
Email 65084 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.