Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000481471
Ethics application status
Approved
Date submitted
2/05/2025
Date registered
19/05/2025
Date last updated
19/05/2025
Date data sharing statement initially provided
19/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Smart-device based atrial fibrillation risk factor tracking for optimising risk factor modification in patients with atrial fibrillation – the SMART-AF study
Scientific title
Smart-device based atrial fibrillation risk factor tracking for optimising risk factor modification in patients with atrial fibrillation – the SMART-AF study
Secondary ID [1] 313607 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 336154 0
Condition category
Condition code
Cardiovascular 332700 332700 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Background: The treatment of cardiovascular risk factors, termed risk factor modification (RFM), has been identified as a crucial component of atrial fibrillation management, This study seeks to utilise the accessibility and advances in technology to help participants engage and track their progress towards optimal RFM.

In addition to standard written and verbal information on the importance of RFM for AF, the intervention will consist of access to a digital RFM tracking platform. This platform will be a web-based tool that can be accessed on a phone or computer, aiming for at least weekly engagement. Adherence to the intervention can be assessed through weekly participant input into the digital RFM tracking platform. Based on performance compared to ideal RFM targets, participants will receive a weekly composite score (out of 100), with a score of 100 aligned with meeting RFM targets across the seven domains (body mass index (BMI), Hba1c, obstructive sleep apnea (OSA) status/continuous positive airway pressure (CPAP) use, alcohol use, cigarette use, exercise, blood pressure). Following RFM logging, through the web-based application participants will receive a visual representation of week-to-week progress and advice on how to best improve their RFM forming a "digital care plan". Written and verbal information part of the digital care plan will be developed for this study. The intervention will be 12 months in duration.
Intervention code [1] 330203 0
Treatment: Devices
Comparator / control treatment
Control group: Participants allocated to the control arm, will receive verbal and written education regarding the importance of RFM for AF outcomes.
Control group
Active

Outcomes
Primary outcome [1] 340229 0
Time to AF recurrence after a 4 week blanking period post randomsation.
Timepoint [1] 340229 0
3 monthly until 12 months (primary timepoint) post randomisation
Primary outcome [2] 340230 0
AF burden at 12 months (after a 4 week blanking period following randomisation).
Timepoint [2] 340230 0
At 12 months post baseline
Secondary outcome [1] 443424 0
Body mass index (BMI)
Timepoint [1] 443424 0
Baseline and 12 months post randomisation
Secondary outcome [2] 447388 0
Blood pressure control - Systolic blood pressure
Timepoint [2] 447388 0
baseline and 12 months post randomisation
Secondary outcome [3] 443423 0
Quality of life
Timepoint [3] 443423 0
Baseline, 6 months and at 12 months post randomisation
Secondary outcome [4] 447392 0
Weekly alcohol intake
Timepoint [4] 447392 0
Baseline and 12 months post randomisation
Secondary outcome [5] 447390 0
Obstructive sleep apnea screening status
Timepoint [5] 447390 0
Baseline and 12 months post randomimsation
Secondary outcome [6] 447394 0
Smoking cessation intervention enrolment
Timepoint [6] 447394 0
Baseline and 12 months post randomisation
Secondary outcome [7] 443425 0
Changes in cardiac structure
Timepoint [7] 443425 0
Baseline and 12 months post baseline.
Secondary outcome [8] 443427 0
Requirements of escalation in therapy
Timepoint [8] 443427 0
Baseline and every 3 months until 12 months post randomisation
Secondary outcome [9] 443426 0
Healthcare utilisation
Timepoint [9] 443426 0
Baseline and every 3 months until 12 months post randomisation
Secondary outcome [10] 447391 0
CPAP use
Timepoint [10] 447391 0
Baseline and 12 months post randomisation
Secondary outcome [11] 447395 0
Changes in cardiac function
Timepoint [11] 447395 0
Baseline and 12 months post randomisation
Secondary outcome [12] 447389 0
Diabetic control
Timepoint [12] 447389 0
Baseline and 12 months post randomisation
Secondary outcome [13] 447393 0
Smoking status (cigarette use)
Timepoint [13] 447393 0
Baseline and 12 months post randomisation

Eligibility
Key inclusion criteria
Age>18 years
Persistent or paroxysmal AF
>2 modifiable AF risk factors
• BMI>27kg/m2
• Hypertension, systolic blood pressure >140mmHg
• HbA1c >7%
• OSA with non-nightly use of CPAP
• Alcohol intake greater than or equal to 10SD/week
• Current daily smoker (>10 cig/day)
Total RFM score of <80
Willing to adhere to follow up requirements
Able to consent & Medicare eligibility
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe valvular disease. History of myocardial infarction or cardiac surgery in previous 12 months.
No access to internet
Any condition with expected survival < 2 years
Unable to provide informed consent or follow-up with requirements
AF ablation in the past 6 months

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)
Allocation concealment: clinicians referring participants for inclusion in the trial will not be aware, when this decision was made, to which group the subject will be allocated. Central randomisation by computer will be performed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient meeting eligibility following baseline screening will undergo baseline assessments and will subsequently be computer randomised in a 1:1 fashion through simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There are two primary endpoints; 1. AF recurrences at 12 months and 2. AF burden over 12 months. Due to these multiple primary endpoints an adjustment is needed to the type I error rate, hence an alpha level of 0.025 will be used for each outcome.

Primary outcome 1: AF burden at 12 months. A previous study looking at an exercise intervention compared changes in AF burden between intervention (exercise) group and control group. The intervention group had a decrease in AF burden from 8.1% (95% CI, 4.1–12.8) to 4.8% (95% CI, 2.0–7.6), compared to control group who had increased AF burden from 10.4% (95% CI, 4.6–17.8) to 14.6% (95% CI, 6.4–24.9) at 20 weeks [15]. Based on these results, a two independent sample superiority study, with an alpha of 0.025 and power of 80% requires a sample size of 68, and 76 after accounting for a 10% cross drop out rate (38 in each group), with RFM trials suggesting the effect of the intervention increases over time.

Primary outcome 2: Time to AF recurrence at 12 months. A previous study looking at an alcohol abstinence, found a 20% decrease of AF recurrence between the intervention (alcohol abstinence) versus control group at 6 months (73% versus 53% respectively). Based on these results, a two independent sample superiority study, with an alpha of 0.025 and power of 80% requires a sample size of 218, or 240 (120 in each group) after accounting for a 10% drop-out rate.

Using the larger sample size estimate, we will require a sample size of 240 participants (120 in each group)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318078 0
Government body
Name [1] 318078 0
The National Health and Medical Research Council
Country [1] 318078 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 320432 0
None
Name [1] 320432 0
Address [1] 320432 0
Country [1] 320432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316725 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316725 0
Ethics committee country [1] 316725 0
Australia
Date submitted for ethics approval [1] 316725 0
26/09/2024
Approval date [1] 316725 0
07/11/2024
Ethics approval number [1] 316725 0

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

Contacts
Principal investigator
Name 138802 0
A/Prof Sandeep Prabhu
Address 138802 0
The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004
Country 138802 0
Australia
Phone 138802 0
+61 0390763263
Fax 138802 0
Email 138802 0
[email protected]
Contact person for public queries
Name 138803 0
Dr Kenneth Cho
Address 138803 0
The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004
Country 138803 0
Australia
Phone 138803 0
+61 390762000
Fax 138803 0
Email 138803 0
[email protected]
Contact person for scientific queries
Name 138804 0
Dr Kenneth Cho
Address 138804 0
The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004
Country 138804 0
Australia
Phone 138804 0
+61 390762000
Fax 138804 0
Email 138804 0
[email protected]

Data sharing statement
Will the study consider sharing 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.