Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
ACTRN12611000967987
Ethics application status
Approved
Date submitted
9/09/2011
Date registered
9/09/2011
Date last updated
9/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of diagnostic imaging in identifying appropriate strategies for heart failure treatment
Scientific title
Stratification of heart failure patients using 123I MIBG SPECT regional analysis compared to standard LVEF based stratification in predicting cardiac event rate and, thus, suitability for implantable defibrilator.
Secondary ID [1] 263012 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 270741 0
Condition category
Condition code
Cardiovascular 270918 270918 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
This is an observational study. The condition observed will be cardiac events including sudden cardiac death. The observation will be in the first instance at 1 and 2 years, however, longituinal data to 5 years will also be evaluated.
Intervention code [1] 269360 0
Not applicable
Comparator / control treatment
There is no control group. Comparison will be made with respect to cardiac events between patients with an LVEF less than 35% and those between 35% and 45%.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279588 0
Sudden cardiac death (or defibrillator discharge) sourced from patient medical records and communication with cardiologist managing the patient.
Timepoint [1] 279588 0
1 year, 2 years, 3 years and 5 years are the time points for evaluation and follow-up.
Secondary outcome [1] 287977 0
Other cardiac events (eg non fatal arrythmia) sourced from patient medical records and communication with cardiologist managing the patient.
Timepoint [1] 287977 0
1 year, 2 years, 3 years and 5 years are the time points for evaluation and follow-up.

Eligibility
Key inclusion criteria
LVEF of 45% or less and in whom NYHA classification rest in the II or III category
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac transplantation, chemotherapy

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269818 0
Charities/Societies/Foundations
Name [1] 269818 0
Defence Health Foundation
Country [1] 269818 0
Australia
Primary sponsor type
Individual
Name
Dr Geoff Currie
Country
Australia
Secondary sponsor category [1] 268850 0
Other Collaborative groups
Name [1] 268850 0
Cardiac Health Institute
Country [1] 268850 0
Australia
Secondary sponsor category [2] 268851 0
University
Name [2] 268851 0
Charles Sturt University
Country [2] 268851 0
Australia
Secondary sponsor category [3] 268852 0
University
Name [3] 268852 0
Australian School of Advanced Medicine, Macquarie University
Country [3] 268852 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271786 0
CSU Human Ethics Research Committee
Ethics committee address [1] 271786 0
Ethics committee country [1] 271786 0
Australia
Date submitted for ethics approval [1] 271786 0
Approval date [1] 271786 0
29/06/2011
Ethics approval number [1] 271786 0
2011.084

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

Contacts
Principal investigator
Name 33137 0
Address 33137 0
Country 33137 0
Phone 33137 0
Email 33137 0
Contact person for public queries
Name 16384 0
Dr Geoff Currie
Address 16384 0
School of Dentistry and Health Sciences Charles Sturt University Locked Bag 588 Wagga Wagga NSW 2678
Country 16384 0
Australia
Phone 16384 0
61 2 69332822
Email 16384 0
gcurrie@csu.edu.au
Contact person for scientific queries
Name 7312 0
Dr Geoff Currie
Address 7312 0
School of Dentistry and Health Sciences Charles Sturt University Locked Bag 588 Wagga Wagga NSW 2678
Country 7312 0
Australia
Phone 7312 0
61 2 69332822
Email 7312 0
gcurrie@csu.edu.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.