Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001506886
Ethics application status
Approved
Date submitted
8/09/2021
Date registered
4/11/2021
Date last updated
13/09/2023
Date data sharing statement initially provided
4/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Observational Prospective Registry of Atrial Fibrillation
Scientific title
An Observational Prospective Registry of Atrial Fibrillation in Australian Adults
Secondary ID [1] 305239 0
None
Universal Trial Number (UTN)
Trial acronym
RECORD-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 323520 0
Condition category
Condition code
Cardiovascular 321077 321077 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The study population will consist of participants with paroxysmal and non-paroxsmal atrial fibrillation (AF) or atrial flutter (AFI) with a diagnosis of non-valvular clinical atrial fibrillation (NVAF). Definition of clinical NVAF is based on 2018 Australian Clinical Guidelines for the Diagnosis and Management of Atrial Fibrillation, which by accepted convention, a documented episode lasting at least 30 seconds is diagnostic.
Clinical investigation data for patients with AF will be collected at baseline and every 12 month, for a minimum of 5 years. Participants will attend an 1-hour consultation at the study hospital every 12 months. Other clinical data will be collected from their medical record in an ongoing basis.
Intervention code [1] 321633 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328857 0
The composite outcomes of cognitive decline and stroke.
The outcomes will be assessed via clinical visit and data-linkage to medical records.
Timepoint [1] 328857 0
The outcome will be assessed every 12 months (months 12, 24, 36, 28, and 60) up to 5 years follow-up after enrolment.
Primary outcome [2] 328858 0
The outcomes of mortality, assessed via clinical visit and data-linkage to medical records.
Timepoint [2] 328858 0
The outcome will be assessed every 12 months (months 12, 24, 36, 28, and 60) up to 5 years follow-up after enrolment.
Primary outcome [3] 328859 0
The composite of outcomes of heart failure and unplanned hospitalizations.
The composite of outcomes of heart failure and unplanned hospitalizations will assessed via clinical visit and data-linkage to medical records.
Timepoint [3] 328859 0
The outcome will be assessed every 12 months (months 12, 24, 36, 28, and 60) up to 5 years follow-up after enrolment.
Secondary outcome [1] 400657 0
incidence of tachycardia induced cardiomyopathy, assessed by data-linkage to medical records
Timepoint [1] 400657 0
The outcome will be assessed every 12 months (months 12, 24, 36, 28, and 60) up to 5 years follow-up after enrolment.

Eligibility
Key inclusion criteria
• Clinical diagnosis of AF
• Capacity to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Less than12 months of life expectancy
• Severe valvular disease i.e. mitral or aortic valve disease
• Cardiac surgery in the last three months, or expected during first six months of study period
• A recent history (< 1 year) of current malignancy, advanced heart failure (NYHA class IV), or end stage COAD or Interstitial lung disease other severe life-threatening comorbidities
• Parkinson’s disease
• Alzheimers disease
• Aphasia
• Severe psychiatric disorders e.g. schizophrenia, schizoaffective disorder or bipolar disorder
• An inability to provide informed consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For the primary objective as we are describing outcomes of participants we will use means and standard deviation for continuous normally distributed data and medians and interquartile range (IQR) for skewed data and frequencies and percentages for categorical variables.

For secondary objectives, association between management of paroxysmal and non-paroxysmal AF and clinical outcomes will be investigated using regression models appropriate for outcomes (e.g. linear regression for continuous normally distributed outcomes) with adjustment for confounding. This model will be repeated for association between treatment strategies and AF control.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/10/2021
Date of last participant enrolment
Anticipated
30/09/2026
Actual
Date of last data collection
Anticipated
30/09/2031
Actual
Sample size
Target
1500
Accrual to date
199
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 20480 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 35250 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 309614 0
University
Name [1] 309614 0
The University of Adelaide
Country [1] 309614 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
Lyell McEwin Hospital
Level 2, University Of Adelaide Education Area
Haydown Road
Elizabeth Vale, SA 5112
Country
Australia
Secondary sponsor category [1] 310629 0
None
Name [1] 310629 0
None
Address [1] 310629 0
None
Country [1] 310629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309389 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 309389 0
Level 3, Roma Mitchell Building | 136 North Terrace, Adelaide, SA 5000
Ethics committee country [1] 309389 0
Australia
Date submitted for ethics approval [1] 309389 0
07/06/2021
Approval date [1] 309389 0
14/07/2021
Ethics approval number [1] 309389 0
2021/HRE00204

Summary
Brief summary
RECORD-AF study will enroll participants with a clinical diagnosis of atrial fibrillation (AF). This study will assess development of stroke and cognitive decline overtime, as well as record mortality rate among patients with AF.

The primary objectives of this study are:
1. Assess the interaction of baseline AF health literacy, social determinants of health and biological aging the incidence of long-term outcomes such as: a) heart failure (HF) (HF preserved ejection fraction (EF), HF midrange EF, and HF reduced EF); b) mortality; c) stroke; d) cognitive decline and e) progression of AF

Secondary objectives of this study are:
1. Determine the impact of blood pressure variability on long-term outcomes, in particular cognitive impairment, in patients with paroxysmal and non-paroxysmal AF.
2. Determine factors associated with development of tachycardia induced cardiomyopathy in AF patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113982 0
Dr Rajiv Mahajan
Address 113982 0
Lyell McEwin Hospital
Level 2, University Of Adelaide Education Area
Haydown Road
Elizabeth Vale, SA 5112
Country 113982 0
Australia
Phone 113982 0
+61 8 8182 9439
Fax 113982 0
Email 113982 0
rajiv.mahajan@adelaide.edu.au
Contact person for public queries
Name 113983 0
Dr Rajiv Mahajan
Address 113983 0
Lyell McEwin Hospital
Level 2, University Of Adelaide Education Area
Haydown Road
Elizabeth Vale, SA 5112
Country 113983 0
Australia
Phone 113983 0
+61 8 8182 9439
Fax 113983 0
Email 113983 0
rajiv.mahajan@adelaide.edu.au
Contact person for scientific queries
Name 113984 0
Dr Rajiv Mahajan
Address 113984 0
Lyell McEwin Hospital
Level 2, University Of Adelaide Education Area
Haydown Road
Elizabeth Vale, SA 5112
Country 113984 0
Australia
Phone 113984 0
+61 8 8182 9439
Fax 113984 0
Email 113984 0
rajiv.mahajan@adelaide.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
The data will be de-identified and reported as aggregate


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.