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Trial registered on ANZCTR


Registration number
ACTRN12612000805875
Ethics application status
Approved
Date submitted
30/07/2012
Date registered
1/08/2012
Date last updated
1/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Echocardiography Guided Optimisation of Cardiac Resynchronization Therapy Late after Implantation
Scientific title
Echocardiography Guided Optimisation of Cardiac Resynchronization Therapy Late after Implantation
Secondary ID [1] 280935 0
Nil
Universal Trial Number (UTN)
Trial acronym
CORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 287030 0
Condition category
Condition code
Cardiovascular 287356 287356 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Heart failure patients with cardiac resynchronization therapy (CRT) devices will be investigated in a 2 stage trial investigating whether no optimization or echocardiographic CRT optimization, either at rest or on exercise, is advantageous.
Optimization will occur by adjusting both the atrioventricular (AV) and ventriculo-ventricular (VV) delay of the CRT device.
Stage 1 - individuals will either be randomized to no optimization or resting optimization. For this we will use the iterative method for the AV delay and the Left Ventricular Outflow Tract Velocity Time Integral (LVOT VTI) method for the VV delay.
Stage 2 - individuals will either be randomized to resting optimization (as in stage 1) or optimization just on completion of a 6 minute walk test (exercise optimization). Resting optimization will be as in stage 1. On exercise (6 minute walk) we will only adjust the VV delay using the difference in time to systolic peak contraction between opposing LV segments at rest and then on exercise.
Individuals will thus be optimized twice in total.
At each visit they will undergo a resting echocardiogram, blood testing and measures of functional capacity such as treadmill walking and 6 minute walk test distance.
Once at the start of stage 1 (month 1) and then at the start of stage 2 (month 7). Each optimization takes roughly 90 mins once per 6 months.
Intervention code [1] 285368 0
Treatment: Devices
Comparator / control treatment
No CRT optimization
Control group
Active

Outcomes
Primary outcome [1] 287626 0
Functional improvement assessed using standard heart failure mechanisms - 6 minute walk distance, treadmill time, peak oxygen consumption on exercise (VO2 max), brain natriuretic peptide (BNP).
Timepoint [1] 287626 0
6 and 12 months
Secondary outcome [1] 298554 0
Echocardiographic improvement in terms of ventricular function and ventricular synchrony. We will measure Simpsons biplane ejection fraction as a measure of left ventricular function and compare change from the start of each stage to the end. we will use the standard deviation fo the time to peak systolic contraction as a measure of left ventricular dyssychrony. Again we will compare change from the start of each stage to the end.
Timepoint [1] 298554 0
6 and 12 months

Eligibility
Key inclusion criteria
We studied individuals who had undergone CRT implantation and were able to perform moderate exercise to level of completion of 6 minute walk test.
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable or unwilling to consent

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)
Consent will be obtained and then randomization occur by sealed opaque envelopes by an independent observer. Neither investigator nor patient will know randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 285716 0
Self funded/Unfunded
Name [1] 285716 0
Address [1] 285716 0
Country [1] 285716 0
Funding source category [2] 285717 0
University
Name [2] 285717 0
Cardiac Imaging Group, University of Queensland
Address [2] 285717 0
School of Medicine
Level 4 Princess Alexandra Hospital
Ipswich Road
Brisbane
Australia
QLD 4102
Country [2] 285717 0
Australia
Primary sponsor type
University
Name
Cardiac Imaging Group, University of Queensland
Address
School of Medicine
Level 4 Princess Alexandra Hospital
Ipswich Road
Brisbane
Australia
QLD 4102
Country
Australia
Secondary sponsor category [1] 284546 0
None
Name [1] 284546 0
Address [1] 284546 0
Country [1] 284546 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287726 0
Princess Alexandra Hospital HREC
Ethics committee address [1] 287726 0
Princess Alexandra Hospital
Ipswich Road
Woollongabba
Brisbane
QLD 4102
Ethics committee country [1] 287726 0
Australia
Date submitted for ethics approval [1] 287726 0
Approval date [1] 287726 0
24/09/2007
Ethics approval number [1] 287726 0
Ethics committee name [2] 287727 0
Uniting Care Health HREC
Ethics committee address [2] 287727 0
First Floor Moorlands House
The Wesley Hospital
451 Coronation Drive
Auchenflower
QLD 4066
Ethics committee country [2] 287727 0
Australia
Date submitted for ethics approval [2] 287727 0
Approval date [2] 287727 0
19/07/2007
Ethics approval number [2] 287727 0

Summary
Brief summary
Cardiac resynchronization therapy pacemaker devices are now an established therapy for heart failure patients. However the optimal method to set up these devices is as yet uncertain. We aim to use echocardiography to optimize these devices on a patient specific basis. We will examine no optimization vs. resting optimization vs exercise optimization in a systematic manor to determine the superior method in terms of functional and cardiac improvment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34505 0
Address 34505 0
Country 34505 0
Phone 34505 0
Fax 34505 0
Email 34505 0
Contact person for public queries
Name 17752 0
Assoc Prof Tony Stanton
Address 17752 0
School of Medicine
Level 4 Princess Alexandra Hospital
Ipswich Road
Brisbane
Australia
QLD 4102
Country 17752 0
Australia
Phone 17752 0
+61 7 3176 5813
Fax 17752 0
Email 17752 0
t.stanton@uq.edu.au
Contact person for scientific queries
Name 8680 0
Assoc Prof Tony Stanton
Address 8680 0
School of Medicine
Level 4 Princess Alexandra Hospital
Ipswich Road
Brisbane
Australia
QLD 4102
Country 8680 0
Australia
Phone 8680 0
+61 7 3176 5813
Fax 8680 0
Email 8680 0
t.stanton@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary