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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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [1] 269818 0
Level 4
380 St Kilda Road
Melbourne VIC 3004
Country [1] 269818 0
Australia
Primary sponsor type
Individual
Name
Dr Geoff Currie
Address
School of Dentsitry and Health Sciences
Locked Bag 588
Charles Sturt University
Wagga Wagga NSW 2678
Country
Australia
Secondary sponsor category [1] 268850 0
Other Collaborative groups
Name [1] 268850 0
Cardiac Health Institute
Address [1] 268850 0
173 Shaftsbury Road
Eastwood NSW 2122
Country [1] 268850 0
Australia
Secondary sponsor category [2] 268851 0
University
Name [2] 268851 0
Charles Sturt University
Address [2] 268851 0
School of Dentsitry and Health Sciences
Locked Bag 588
Charles Sturt University
Wagga Wagga NSW 2678
Country [2] 268851 0
Australia
Secondary sponsor category [3] 268852 0
University
Name [3] 268852 0
Australian School of Advanced Medicine, Macquarie University
Address [3] 268852 0
2 Technology Place
Macquarie University
North Ryde NSW 2109
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
Academic Secretariat
Bathurst Campus
Private Mail Bag 29
Charles Sturt university
Bathurst NSW 2795
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
The study is a prospective follow-up of major cardiac events in patients presenting with confirmed CHF with LVEF of 45% or less and in whom NYHA classification rest in the II or III category. Patients will follow standard management plans informed by their HF classification, LVEF and global mIBG quantitation.

The proposed project would allow prospective data to be collected with follow-up to 2 years, and provide an initial validation of our proposed novel 3-D tomographic SPECT based regional quantitation of myocardial uptake and washout of 123I-mIBG against the traditional more established global approaches using planar 2-D imaging. Our assertion is that regional quantitation should provide more accurate risk stratification than the existing global approaches. This information requires up to 24 months follow-up of cardiac events in patients presenting with heart failure. A follow-up to 5 years will be undertaken.

Hypothesis: 123I-mIBG SPECT provides stratification of CHF patients most likely to benefit from aggressive management, independently of LVEF.

Primary Aims:
1. Determine whether 123I-mIBG is independently predictive of SCD or ICD discharge in CHF patients with LVEF less than or equal to 35%.
2. Determine whether 123I-mIBG is independently predictive of SCD in CHF patients with LVEF greater than 35%.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 33137 0
Address 33137 0
Country 33137 0
Phone 33137 0
Fax 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
Fax 16384 0
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
Fax 7312 0
Email 7312 0
gcurrie@csu.edu.au

No information has been provided regarding IPD availability
Summary results
No Results