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Trial registered on ANZCTR


Registration number
ACTRN12610000231044
Ethics application status
Not yet submitted
Date submitted
19/02/2010
Date registered
19/03/2010
Date last updated
19/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing a six minute walk test with a standard 24 hour holter monitor for the assessment of ventricular rate control in permanent atrial fibrillation.
Scientific title
Comparing a six minute walk test with a standard 24 hour holter monitor for the assessment of ventricular rate control in permanent atrial fibrillation-a noninferiority trial
Secondary ID [1] 1475 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 256859 0
Condition category
Condition code
Cardiovascular 257007 257007 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
subjects will perform a 6 minute walk with a cardiac monitor on and maximal heart rate and time above certain threshholds measured. The subject will then have a 24 hour Holter monitor attached and similar measures to above made. These will then be compared to ensure non inferiority of6 minute walk. Each will be a one off assessment. over duration of enrollment will be 3 months
Intervention code [1] 256055 0
Not applicable
Comparator / control treatment
Act as own controls
Control group
Active

Outcomes
Primary outcome [1] 257904 0
maximal heart rate will be compared between the two methods as well as time above certain thresholds (ventricular heart rate of 115 and 100). These will be assessed by using cardiac monitors and 24 holter monitors and assessed by those with skills at reading them
Timepoint [1] 257904 0
At time of 6 minute walk and of 24 hour holter monitor
Secondary outcome [1] 263507 0
nil
Timepoint [1] 263507 0
nil

Eligibility
Key inclusion criteria
Permanent Atrial fibrillation
Able to mobilise
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not in atrial fibrillation
self reported pregnancy
pacemaker

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2500 0
New Zealand
State/province [1] 2500 0

Funding & Sponsors
Funding source category [1] 256558 0
Hospital
Name [1] 256558 0
hutt Hospital
Country [1] 256558 0
New Zealand
Primary sponsor type
Individual
Name
John Wilson
Address
Hutt Hospital
High St
Lower Hutt
5010
Wellington
Country
New Zealand
Secondary sponsor category [1] 255854 0
Individual
Name [1] 255854 0
Timothy Omeeghan
Address [1] 255854 0
Hutt Hospital
High St
Lower Hutt
5010
Wellington
Country [1] 255854 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258596 0
Ethics committee address [1] 258596 0
Ethics committee country [1] 258596 0
Date submitted for ethics approval [1] 258596 0
22/02/2010
Approval date [1] 258596 0
Ethics approval number [1] 258596 0

Summary
Brief summary
the primary purpose is to show that the use of a simple inexpensive test such as a 6 minute walk with measuring of heart rate is as good as the more inconvienient, time consuming and expensive but gold standard test of 24 holter monitor in assessing moderate exercise ventricular heart rate control in atrial fibrillation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30864 0
Address 30864 0
Country 30864 0
Phone 30864 0
Fax 30864 0
Email 30864 0
Contact person for public queries
Name 14111 0
Dr John Wilson
Address 14111 0
Cardiology Department
Hutt Hospital
High St
Lower Hutt
5010
Wellington
Country 14111 0
New Zealand
Phone 14111 0
+64 4 5666999
Fax 14111 0
Email 14111 0
[email protected]
Contact person for scientific queries
Name 5039 0
Dr John Wilson
Address 5039 0
Cardiology Department
Hutt Hospital
High St
Lower Hutt
5010
Wellington
Country 5039 0
New Zealand
Phone 5039 0
+64 4 5666999
Fax 5039 0
Email 5039 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.