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Trial registered on ANZCTR


Registration number
ACTRN12616001498482
Ethics application status
Approved
Date submitted
24/10/2016
Date registered
28/10/2016
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
CRT-OPT- A randomized trial of benefit and cost-effectiveness of Cardiac Resynchronization Therapy (CRT) optimization in heart failure
Scientific title
CRT-OPT- A randomized trial of benefit and cost-effectiveness of Cardiac Resynchronization Therapy (CRT) optimization in heart failure
Secondary ID [1] 290373 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
CRT-OPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 300677 0
Cardiac resynchronization Therapy 300678 0
Condition category
Condition code
Cardiovascular 300527 300527 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized, double-blind, cross-over trial to evaluate the utility of echocardiographic optimization of the AV delay in symptomatic (Functional Class [FC] III) CHF patients who have had CRT implanted.
Optimization is a process undertaken by a pacing technician during echo. Those who are randomized to the optimization group (known only to the study Nurse and the technician) will have their CRT device 'optimized ' by radio frequency. This procedure can take between 15 and 30 minutes and alters the amount of electrical current delivered to the pacing wires of the device in order to produce "optimal' pumping by the heart chambers. It is non-invasive and the procedure is not a new technique. It is not universally used though as its efficacy in producing improved outcomes has yet to be determined.
Intervention code [1] 296198 0
Treatment: Devices
Comparator / control treatment
Those who are randomized to the control arm of the study (known only to the study nurse and pacing technician) will undergo the same echocardiographic procedures, however their device will not be "optimized' by a radiofrequency device as those in the intervention arm will.
Control group
Placebo

Outcomes
Primary outcome [1] 299948 0
Functional capacity as defined by 6-MWT distance.
Timepoint [1] 299948 0
6 months post optimization
Secondary outcome [1] 328634 0
Naughton treadmill protocol stress test
Timepoint [1] 328634 0
6 months post optimzation
Secondary outcome [2] 328670 0
QoL questionnaires: EQ5D, AQoL and MLHFQ
Timepoint [2] 328670 0
6 months post optimzation
Secondary outcome [3] 328671 0
Percentage days alive and out of hospital score as determined by medical record review
Timepoint [3] 328671 0
6 months post optimization
Secondary outcome [4] 328672 0
B-type natriuretic peptide assessed by serum assay
Timepoint [4] 328672 0
6 months post optimization
Secondary outcome [5] 328673 0
composite secondary outcome- Left ventricular volumes/function[2D/3D]/strain analysis as determined by echocardiographic assessment
Timepoint [5] 328673 0
6 months post optimization
Secondary outcome [6] 328674 0
Incremental cost effectiveness ratio for CRT optimization (vs non-optimization) from a health care payer’s perspective as determined by number of in-hospital days identified through medical record review
Timepoint [6] 328674 0
6 months post optimization

Eligibility
Key inclusion criteria
* History of implanted CRT device
* Device optimization performed at time of implant [e.g. QuickOpt for St Jude etc.]
* In sinus rhythm
* Able to perform a 6-minute walk test
* No more than moderate valvular heart disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Life expectancy <1 year
* In atrial fibrillation
* Prosthetic mitral valve replacement.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The information gathered in this study will permit the development of a Markov model to study cost-effectiveness. Requisite parameters will relate to transition probabilities (e.g. frequency of CHF admission, new AF, lead revision), utilities (derived from EQ5D and AQoL before and after treatment in each group) and cost (based on patient self-report) including medication and pathology costs, days of hospitalization, specialist appointments and costs of imaging.
Power calculations. In our preliminary data, baseline 6MW was 384m, and there was a 30m increment post-optimization. This matches our meta-analysis, where 5 of 6 studies showed an improvement from 11-75m. A study of 100 patients per group would allow us to identify an 8% improvement of 6MW (SD of 80) at a p=0.05, and cluster-adjusted power of 80% (assuming intra- class correlation 0.01). This will also provide 80% power to show an 8% change in exercise capacity (baseline 3.0 +/- 0.7 METS).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/11/2016
Actual
12/07/2017
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
30/10/2019
Actual
Sample size
Target
200
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment hospital [1] 6856 0
The Alfred - Prahran
Recruitment hospital [2] 6857 0
Royal Hobart Hospital - Hobart
Recruitment hospital [3] 12541 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 14521 0
3004 - Prahran
Recruitment postcode(s) [2] 14522 0
7000 - Hobart
Recruitment postcode(s) [3] 24923 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 294764 0
Charities/Societies/Foundations
Name [1] 294764 0
Heart Foundation
Country [1] 294764 0
Australia
Primary sponsor type
Other
Name
The Baker IDI
Address
75 Commercial Road, Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 293610 0
University
Name [1] 293610 0
University of Queensland
Address [1] 293610 0
UQ school of Medicine
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Qld 4102
Country [1] 293610 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296171 0
The Alfred Ethics Committee
Ethics committee address [1] 296171 0
260 Kooyong Road, Caulfield Victoria 3162
Ethics committee country [1] 296171 0
Australia
Date submitted for ethics approval [1] 296171 0
15/03/2016
Approval date [1] 296171 0
15/03/2016
Ethics approval number [1] 296171 0
HREC/16/ALFRED/64

Summary
Brief summary
The aim is to determine whether sequential optimization of cardiac resynchronization therapy (CRT) can improve outcome in advanced chronic heart failure (CHF). The efficacy of this strategy will be established by assessment of functional capacity using measurement of 6-minute walk test distance (6MWT), B-type natriuretic peptide (BNP), echocardiographic measures and quality of life (QoL, based on a disease specific questionnaire: Minnesota Living with Heart Failure questionnaire, MLHFQ, and the multi-attribute utility indices: EQ-5D and Assessment of Quality of Life (AQoL). The cost- effectiveness of the strategy will also be assessed, relative to non-optimization. The hypotheses are that optimization of atrioventricular delay (AVD) setting will lead to (1) improved exercise capacity (2) improved BNP, LV structure and QoL over the ensuing 6 months, and be (3) cost-effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69854 0
A/Prof Tony Stanton
Address 69854 0
University of Queensland
School of Medicine
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Q 4102
Country 69854 0
Australia
Phone 69854 0
+61 429117050
Fax 69854 0
Email 69854 0
[email protected]
Contact person for public queries
Name 69855 0
Sarah McLennan
Address 69855 0
University of Queensland
School of Medicine
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Q 4102
Country 69855 0
Australia
Phone 69855 0
+61 7 3176 7500
Fax 69855 0
Email 69855 0
[email protected]
Contact person for scientific queries
Name 69856 0
Tony Stanton
Address 69856 0
University of Queensland
School of Medicine
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba Q 4102
Country 69856 0
Australia
Phone 69856 0
+61 429117050
Fax 69856 0
Email 69856 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
As the trial is not progressing as predicted, how the data will be shared is currently under review


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
485Study protocol    371699-(Uploaded-26-11-2018-10-27-34)-Study-related document.docx



Results publications and other study-related documents

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