Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000004561
Ethics application status
Approved
Date submitted
21/12/2005
Date registered
4/01/2006
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
International, multicentre: Perhexiline in Aortic Stenosis study.
Scientific title
Effects of perhexiline on the symptomatic status in elderly patients with severe aortic stenosis.
Universal Trial Number (UTN)
Trial acronym
IMPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sever aortic stenosis. 965 0
Condition category
Condition code
Cardiovascular 1037 1037 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Perhexiline 100mgs BD for 8 weeks.
Intervention code [1] 813 0
Treatment: Drugs
Comparator / control treatment
Placebo for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 1387 0
Symptomatic status. It is anticipated that there will be an improvement in symptomatic status after 8 weeks of therapy.
Timepoint [1] 1387 0
After 8 weeks of treatment
Secondary outcome [1] 2453 0
Functional class, LV function, 6 min walk distance, quality of life as assessed via SF36 and Minnesota Living with Heart Failure questionnaires, BNP concentration.
Timepoint [1] 2453 0
After 8 weeks of therapy.
Secondary outcome [2] 2454 0
Symptomatic status over long term treatment, correlations between perhexiline level and symptomatic improvement and long term effects.
Timepoint [2] 2454 0
After 52 weeks of therapy.

Eligibility
Key inclusion criteria
AVA of < 0.1cm sq. Symptoms of angina and/or exertional shortness of breath.
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)
Blinded study drug allocated by unblinded pharmacist. Patients were randomised by completing a randomisation form which was faxed to unblinded pharmacist. Treatment allocation confirmed by fax.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of patients was stratified according to the presence or absence of coronary artery disease. Sequence of allocation generated via computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1137 0
Commercial sector/Industry
Name [1] 1137 0
Sigma Pharmaceuticals
Country [1] 1137 0
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital,Cardiology Department
Address
Country
United Kingdom
Secondary sponsor category [1] 994 0
None
Name [1] 994 0
NA
Address [1] 994 0
Country [1] 994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2449 0
The Queen Elizabeth Hospital,
Ethics committee address [1] 2449 0
Ethics committee country [1] 2449 0
Australia
Date submitted for ethics approval [1] 2449 0
Approval date [1] 2449 0
Ethics approval number [1] 2449 0
Ethics committee name [2] 2450 0
The Lyell McEwin Health Service
Ethics committee address [2] 2450 0
Ethics committee country [2] 2450 0
Australia
Date submitted for ethics approval [2] 2450 0
Approval date [2] 2450 0
Ethics approval number [2] 2450 0
Ethics committee name [3] 2451 0
Flinders Medical Centre
Ethics committee address [3] 2451 0
Ethics committee country [3] 2451 0
Australia
Date submitted for ethics approval [3] 2451 0
Approval date [3] 2451 0
Ethics approval number [3] 2451 0
Ethics committee name [4] 2452 0
Austin Hospital
Ethics committee address [4] 2452 0
Ethics committee country [4] 2452 0
Australia
Date submitted for ethics approval [4] 2452 0
Approval date [4] 2452 0
Ethics approval number [4] 2452 0
Ethics committee name [5] 2453 0
Concord Repatriation Hospital
Ethics committee address [5] 2453 0
Ethics committee country [5] 2453 0
Australia
Date submitted for ethics approval [5] 2453 0
Approval date [5] 2453 0
Ethics approval number [5] 2453 0
Ethics committee name [6] 2454 0
Prince Charles Hospital
Ethics committee address [6] 2454 0
Ethics committee country [6] 2454 0
Australia
Date submitted for ethics approval [6] 2454 0
Approval date [6] 2454 0
Ethics approval number [6] 2454 0
Ethics committee name [7] 2455 0
Christchurch Hospital
Ethics committee address [7] 2455 0
Ethics committee country [7] 2455 0
New Zealand
Date submitted for ethics approval [7] 2455 0
Approval date [7] 2455 0
Ethics approval number [7] 2455 0
Ethics committee name [8] 2456 0
Green Lane Hospital
Ethics committee address [8] 2456 0
Ethics committee country [8] 2456 0
New Zealand
Date submitted for ethics approval [8] 2456 0
Approval date [8] 2456 0
Ethics approval number [8] 2456 0
Ethics committee name [9] 2457 0
Sahlgrenska University Hospital
Ethics committee address [9] 2457 0
Ethics committee country [9] 2457 0
Sweden
Date submitted for ethics approval [9] 2457 0
Approval date [9] 2457 0
Ethics approval number [9] 2457 0
Ethics committee name [10] 2458 0
University of Wales
Ethics committee address [10] 2458 0
Ethics committee country [10] 2458 0
United Kingdom
Date submitted for ethics approval [10] 2458 0
Approval date [10] 2458 0
Ethics approval number [10] 2458 0

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

Contacts
Principal investigator
Name 35363 0
Address 35363 0
Country 35363 0
Phone 35363 0
Fax 35363 0
Email 35363 0
Contact person for public queries
Name 10002 0
Sue leslie
Address 10002 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 10002 0
Australia
Phone 10002 0
+61 8 82226000
Fax 10002 0
+61 8 82227021
Email 10002 0
sue.leslie@nwahs.sa.gov.au
Contact person for scientific queries
Name 930 0
Prof John Horowitz
Address 930 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 930 0
Australia
Phone 930 0
+61 8 82226000
Fax 930 0
+61 8 82227201
Email 930 0
sue.leslie@nwahs.sa.gov.au

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.