Trial Review

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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
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
Scientific title
Analysis of brain natriuretic peptide levels in patients with atrial fibrillation undergoing atrioventricular node ablation
Secondary ID [1] 299775 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 315142 0
AV Node Ablation 315143 0
Condition category
Condition code
Cardiovascular 313459 313459 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 316031 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321929 0
Percentage change in transcardiac BNP gradient, measured from blood samples before and after the procedure
Timepoint [1] 321929 0
40 minutes following the procedure
Secondary outcome [1] 376725 0
Change in high-sensitivity troponin (hs-TnI) measured from blood samples
Timepoint [1] 376725 0
40 minutes following the procedure

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
3/02/2020
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
30
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15132 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28426 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304240 0
Government body
Name [1] 304240 0
Pathology Queensland - Study, Education and Research Committee
Country [1] 304240 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Rd
Woolloongabba
QLD 4102
Country
Australia
Secondary sponsor category [1] 304479 0
None
Name [1] 304479 0
Address [1] 304479 0
Country [1] 304479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304699 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 304699 0
Ethics committee country [1] 304699 0
Australia
Date submitted for ethics approval [1] 304699 0
01/11/2018
Approval date [1] 304699 0
14/01/2019
Ethics approval number [1] 304699 0
HREC/2018/QMS/45665

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

Contacts
Principal investigator
Name 97914 0
A/Prof Paul Gould
Address 97914 0
Princess Alexandra Hospital Department of Cardiology 199 Ipswich Rd Woolloongabba QLD 4102
Country 97914 0
Australia
Phone 97914 0
+61 7 3176 2000
Fax 97914 0
Email 97914 0
[email protected]
Contact person for public queries
Name 97915 0
Paul Gould
Address 97915 0
Princess Alexandra Hospital Department of Cardiology 199 Ipswich Rd Woolloongabba QLD 4102
Country 97915 0
Australia
Phone 97915 0
+61 7 3176 2000
Fax 97915 0
Email 97915 0
[email protected]
Contact person for scientific queries
Name 97916 0
Paul Gould
Address 97916 0
Princess Alexandra Hospital Department of Cardiology 199 Ipswich Rd Woolloongabba QLD 4102
Country 97916 0
Australia
Phone 97916 0
+61 7 3176 2000
Fax 97916 0
Email 97916 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a sound methodological proposal for use of the data

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data that underlie the results of the trial after de-identification

What types of analyses could be done with individual participant data?
• To achieve aims stated in the study proposal

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication. No end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Proposals should be directed to the Principal Investigator listed on this study

Are there extra considerations when requesting access to individual participant data?
No


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.