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Trial registered on ANZCTR
Registration number
ACTRN12619001590156
Ethics application status
Approved
Date submitted
11/11/2019
Date registered
19/11/2019
Date last updated
9/05/2022
Date data sharing statement initially provided
19/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Analysis of brain natriuretic peptide levels in patients with atrial fibrillation undergoing atrioventricular node ablation
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Scientific title
Analysis of brain natriuretic peptide levels in patients with atrial fibrillation undergoing atrioventricular node ablation
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Secondary ID [1]
299775
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
315142
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AV Node Ablation
315143
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Condition category
Condition code
Cardiovascular
313459
313459
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The study will measure levels of the proteins brain natriuretic peptide (BNP) and troponin (hs-TnI) in a prospective cohort of patients undergoing atrioventricular (AV) node ablation and measure the differences before and after the procedure. Blood samples will be collected from three different sites, the vein, the artery and within the heart (coronary sinus) at the start of the procedure and then 20 and 40 minutes following the procedure. The study will be conducted on the day of the procedure only.
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Intervention code [1]
316031
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Percentage change in transcardiac BNP gradient, measured from blood samples before and after the procedure
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Assessment method [1]
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Timepoint [1]
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40 minutes following the procedure
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Secondary outcome [1]
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Change in high-sensitivity troponin (hs-TnI) measured from blood samples
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Assessment method [1]
376725
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Timepoint [1]
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40 minutes following the procedure
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Eligibility
Key inclusion criteria
o Age greater than or equal to 18 years
o Permanent atrial fibrillation
o Left ventricular ejection fraction (LVEF) >45%
o Clinical indication for AV node ablation
o Permanent pacemaker already implanted or planned to be implanted prior to AV node ablation
o Able to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
o Age < 18 years
o Inability to provide consent
o LVEF <45% or decompensated heart failure
o Severe valvular lesions
o Pregnancy
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
A sample size of 30 patients was targeted, with this technique, assuming a within-patient BNP assay variability of 10%, this will give 90% power to detect a difference of 10% in BNP levels following procedure given the crossover design. Data will be analysed using descriptive statistics, within group data will use paired t-tests where normally distributed. Nominal or categorical data were compared using a Chi-squared test or a Fischer Exact Test where appropriate.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/12/2019
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Actual
3/02/2020
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Date of last participant enrolment
Anticipated
1/06/2022
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Actual
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Date of last data collection
Anticipated
1/06/2022
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Actual
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Sample size
Target
30
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Accrual to date
3
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
15132
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
28426
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Pathology Queensland - Study, Education and Research Committee
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Address [1]
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Pathology Queensland
Level 4, Block 7
Royal Brisbane and Women's Hospital
Cnr Herston and Bowen Bridge Roads
Herston Qld 4006
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Country [1]
304240
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Australia
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Primary sponsor type
Hospital
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Name
Princess Alexandra Hospital
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Address
199 Ipswich Rd
Woolloongabba
QLD 4102
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
304479
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Country [1]
304479
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304699
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
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Metro South Research Level 7, Translational Research Institute 37 Kent Street Woolloongabba QLD 4102
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Ethics committee country [1]
304699
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Australia
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Date submitted for ethics approval [1]
304699
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01/11/2018
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Approval date [1]
304699
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14/01/2019
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Ethics approval number [1]
304699
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HREC/2018/QMS/45665
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Summary
Brief summary
Atrial fibrillation (AF) is common irregular rapid heart rhythm which happens in about 5% of people. Some patients have symptoms regardless of medication and a procedure is needed to get rid of these symptoms. This procedure uses an electrical current to burn the pathway between the top and the bottom part of the heart. What is not known is the way the heart changes after the procedure and if the benefits are due only to a slower heart rate or more complex processes. One way to measure the heart's response to the procedure is by taking blood to test for cardiac biomarkers (BNP and cTnI). Currently it is unknown how these biomarkers respond immediately after the procedure. Our study will enroll 30 patients who are having this procedure. Blood samples will be taken from the heart and artery during the procedure to measure BNP and cTnI. How the levels of BNP and TnI react during the procedure will help us decide the site in the heart where these are released from and what triggers their release.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Paul Gould
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Address
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Princess Alexandra Hospital
Department of Cardiology
199 Ipswich Rd
Woolloongabba
QLD 4102
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Country
97914
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Australia
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Phone
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+61 7 3176 2000
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Fax
97914
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Email
97914
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[email protected]
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Contact person for public queries
Name
97915
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Paul Gould
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Address
97915
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Princess Alexandra Hospital
Department of Cardiology
199 Ipswich Rd
Woolloongabba
QLD 4102
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Country
97915
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Australia
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Phone
97915
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+61 7 3176 2000
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Fax
97915
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Email
97915
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[email protected]
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Contact person for scientific queries
Name
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Paul Gould
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Address
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Princess Alexandra Hospital
Department of Cardiology
199 Ipswich Rd
Woolloongabba
QLD 4102
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Country
97916
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Australia
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Phone
97916
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+61 7 3176 2000
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Fax
97916
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Email
97916
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data that underlie the results of the trial after de-identification
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When will data be available (start and end dates)?
Immediately following publication. No end date.
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Available to whom?
Researchers who provide a sound methodological proposal for use of the data
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Available for what types of analyses?
To achieve aims stated in the study proposal
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How or where can data be obtained?
Proposals should be directed to the Principal Investigator listed on this study
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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.
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