Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000685819
Ethics application status
Approved
Date submitted
24/03/2021
Date registered
4/06/2021
Date last updated
4/06/2021
Date data sharing statement initially provided
4/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Sodium-glucose co-transporter 2 inhibition prior to atrial fibrillation ablation: A pilot randomised controlled trial
Scientific title
The effect of sodium-glucose co-transporter 2 inhibition prior to atrial fibrillation ablation on electrophysiological and clinical markers of atrial fibrillation: A pilot randomised controlled trial.
Secondary ID [1] 303779 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation 321280 0
Condition category
Condition code
Cardiovascular 319059 319059 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomisation to dapagliflozin tablet, orally, 10mg daily for 1 month before and after atrial fibrillation ablation, versus standard of care.
Total duration of treatment is 56 days. Treatment will be initiated 31 days prior to AF ablation and participants will receive 28 days of medication, then the medication will be withheld for 3 days prior to AF ablation, and withheld on the day of the AF ablation. Treatment will be re-initiated on the first post-procedural day, if the participant is eating and drinking normally. Post procedurally, the medication will be given for 28 days.

The pharmacy department will record the date of dispensing, and the number of tablets given. The pharmacy department also ask the participants to return unused medications, the number of unused tablets will be recorded on the study log.

Participants will be provided with an AliveCor cardiac monitor, to transmit their cardiac traces twice a day post-procedurally.
Participants taking dapagliflozin will be phoned every 2 weeks during the trial period, and 3 days before ablation to ensure cessation of medication while fasting.
Participants will be given a trial information booklet.
Cardiology consultants and fellows will be responsible for administering the trial, some elements over the phone and some in person visits; initial visit for consent/ collecting medication in person, phonecall after 2 weeks, another phonecall after 11 days, another phonecall 2 weeks post ablation, an in person visit 4 weeks after ablation for trial completion.
Intervention code [1] 320086 0
Treatment: Drugs
Comparator / control treatment
Control group is standard of care

The control group will receive standard of care, meaning that there will be no alterations to medications for participants in this group. Participants randomised to the control group (standard of care) will receive their usual medications, without the addition of a SGLT2 inhibitor, there will be no placebo tablet. Participants in the control group will not receive phonecalls at week 2 and 4 of study enrollment from study doctors as would the treatment group, as no intervention has been undertaken. At the time of atrial fibrillation ablation, both the control group and the treatment group will undergo the same intraprocedural electrophysiologic assessment. Post-ablation, both the control group and the treatment group will be asked to submit electronic traces of their heart rhythm twice a day, and if they experience symptoms, for one month following their ablation.
Control group
Active

Outcomes
Primary outcome [1] 327409 0
Atrial fibrillation burden; proportion of traces showing atrial fibrillation

Participants will be asked to return two traces each day of their heart rhythm, and additional traces if they experience symptoms concerning for atrial fibrillation, via their AliveCor device and compatible smartphone.
Timepoint [1] 327409 0
Assessed once daily for 1 month post ablation.
Primary outcome [2] 327411 0
Change in the rate constants between the treatment and control groups.

Rate constants are calculated from data collected at the time of electrophysiology study. Raw electrograms collected will be processed using custom Matlab software, to determine the electrophysiologic rate constant.
Timepoint [2] 327411 0
Data collected at the time of ablation (during the procedure).
The ablation will occur following 4 weeks of drug treatment.
Primary outcome [3] 327759 0
Change in electrogram fractionation between the treatment and control groups.

Electrogram fractionation is assessed from the raw electrograms collected during the electrophysiology study.
Timepoint [3] 327759 0
Data collected at the time of ablation (during the procedure).
The ablation will occur following 4 weeks of drug treatment.
Secondary outcome [1] 395007 0
Time to first recurrence of atrial fibrillation

Cardiac monitoring is performed in hospital for 24 hours post ablation. Subsequently, participants will be asked to return two traces each day of their heart rhythm, and additional traces if they experience symptoms concerning for atrial fibrillation via their AliveCor device and compatible smartphone. The first recurrence of atrial fibrillation will be the first documented atrial fibrillation following ablation. The time to recurrence is the time in days to first recurrence of atrial fibrillation.
Timepoint [1] 395007 0
Assessed once daily for 1 month post ablation.
Secondary outcome [2] 395009 0
Change in bipolar voltages between the treatment and control groups.

Bipolar voltages are collected from the raw electrograms collected during the electrophysiology study.
Timepoint [2] 395009 0
Data collected at the time of ablation (during the procedure).
The ablation will occur following 4 weeks of drug treatment.

Eligibility
Key inclusion criteria
Patients referred for clinically indicated AF ablation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People under the age of 18.
Patients who are unable or unwilling to provide consent.
Considerations related to AF ablation procedure (presence of left atrial thrombus, previous AF ablation, contraindication to anticoagulation).
Exclusions related to SGLT2 commencement; patients already taking SGLT2 inhibitors, history of impaired kidney function (eGFR <45mL/min/1.73m2), Child-Pugh Class C liver disease, pregnancy/ breastfeeding, symptomatic hypotension/ systolic blood pressure <100mmHg, type 1 diabetes mellitus, or previous SGLT2 intolerance or allergy, in line with current published contraindications to therapy.

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Exploratory analyses will be performed on each of the endpoints for the active versus control groups. For the AF burden endpoint, each participant will submit 2 traces per day for one month of their cardiac rhythm over the one month post-ablation period. Preliminary data from RENEWAL-AF, a currently underway trial (ACTRN12619001172190), demonstrated that 5.4% of overall traces had AF detected. A p value of <0.05 will be considered statistically significant.
Secondary end points will be compared in similar manner and will be considered exploratory and therefore no adjustment of the significance level for multiple testing will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2021
Actual
Date of last participant enrolment
Anticipated
1/05/2022
Actual
Date of last data collection
Anticipated
4/07/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 18999 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 33540 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 308180 0
Charities/Societies/Foundations
Name [1] 308180 0
National Heart Foundation, Vanguard Grant
Country [1] 308180 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
Sturt Road, Bedford Park, SA 5042.
Country
Australia
Secondary sponsor category [1] 308961 0
None
Name [1] 308961 0
Address [1] 308961 0
Country [1] 308961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308165 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 308165 0
Ethics committee country [1] 308165 0
Australia
Date submitted for ethics approval [1] 308165 0
Approval date [1] 308165 0
10/03/2021
Ethics approval number [1] 308165 0
308.20

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

Contacts
Principal investigator
Name 109766 0
A/Prof Anand Ganesan
Address 109766 0
Department of Cardiology, Level 6, Flinders Medical Centre. Flinders Drive, Bedford Park SA 5042.
Country 109766 0
Australia
Phone 109766 0
+61 08 82045619
Fax 109766 0
Email 109766 0
anand.ganesan@flinders.edu.au
Contact person for public queries
Name 109767 0
Anand Ganesan
Address 109767 0
Department of Cardiology, Level 6, Flinders Medical Centre. Flinders Drive, Bedford Park SA 5042.
Country 109767 0
Australia
Phone 109767 0
+61 08 82045619
Fax 109767 0
Email 109767 0
anand.ganesan@flinders.edu.au
Contact person for scientific queries
Name 109768 0
Anand Ganesan
Address 109768 0
Department of Cardiology, Level 6, Flinders Medical Centre. Flinders Drive, Bedford Park SA 5042.
Country 109768 0
Australia
Phone 109768 0
+61 08 82045619
Fax 109768 0
Email 109768 0
anand.ganesan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.