Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000711213
Ethics application status
Approved
Date submitted
24/04/2018
Date registered
1/05/2018
Date last updated
1/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation in atrial remodelling and the risk of arrhythmias in endurance athletes
Scientific title
Atrial remodelling and risk of arrhythmias in endurance athletes
Secondary ID [1] 292776 0
None
Universal Trial Number (UTN)
U1111_1212_8188
Trial acronym
ProAFHeart
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 307562 0
Athlete's heart 307563 0
Atrial remodeling 307564 0
Condition category
Condition code
Cardiovascular 306638 306638 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Testing of the participants will happen at baseline and a repeat test after 2 years.
Testing includes:
Echocardiography
Electrocardiogram
VO2 max test
Blood samples
Holter monitor recording for 3 days
Cardiac MRI (Magnetic Resonance Imaging)
Dexa scan to measure body composition and bone mineral density
Anthropological measures (height and weight)
1 week training diary (electronic or paper copy)
Health questionnaire
Intervention code [1] 300995 0
Diagnosis / Prognosis
Comparator / control treatment
Endurance athletes will be aged and gender matched to healthy non-athletic controls.
A healthy non-athletic control is not involved in any sports competition, is not enrolled in a fitness program to improve their fitness, does less than 3hours of leisure exercise per week.
Age groups will also be compared with each other.
Control group
Active

Outcomes
Primary outcome [1] 305636 0
Presence of atrial fibrillation assessed by electrocardiogram and holter monitoring
Timepoint [1] 305636 0
Comparison between athletic and non-athletic cohorts at baseline testing
Primary outcome [2] 305637 0
Assessment of atrial structure on Cardiac Magnetic Resonance Imaging and echocardiogram
Timepoint [2] 305637 0
Comparison of the age groups at baseline and after 2 years.
Secondary outcome [1] 346112 0
Fitness status assessed by a VO2 max test with a continuous ramp protocol on a bike ergometer and metabolic chart
Timepoint [1] 346112 0
At baseline testing and after 2 years
Secondary outcome [2] 346113 0
Cardiac markers, BNP, Troponin and fasting lipid profile assessed by a blood test
Timepoint [2] 346113 0
Baseline testing and 2 years after
Secondary outcome [3] 346114 0
Assessment of exercise training by recording daily exercise activities on a 7-day training diary or by electronic recording on TrainingPeaks
Timepoint [3] 346114 0
At baseline recorded for 1 week
Secondary outcome [4] 346115 0
assessment of cardiovascular risk factors and medical history using a questionnaire
Timepoint [4] 346115 0
At baseline
Secondary outcome [5] 346116 0
Assessment of body composition and bone mineral density using a DEXA scanner
Timepoint [5] 346116 0
Baseline and after 2 years

Eligibility
Key inclusion criteria
Young athlete: 16-23 years, competing in elite endurance sport. Within 24 months of starting elite competition.
Retiring athletes: 28-45 years, competing in elite endurance sport. Within 12 months of retiring of elite competition
Retired athlete: 45-80 years. rowers who competed at state, national or international level for a duration of 10 years when younger.

Age and gender matched non-athletic group: Not competing in sport, less than 3 hours of leisure activity per month, not enrolled in a fitness program to improve fitness.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
You will be ineligible for this study if:
- You have a metal implant or history of an operation that would exclude you from being studied in the CMR scanner.
- You are pregnant or breast feeding that would exclude you from being studied in the DEXA scanner.
- A comprehensive list of contraindications will be discussed prior to scanning which are important to ensure that there are no metallic foreign objects in the eye and other uncommon issues which are important to exclude.
if you are diagnosed with a cardiopulmonary disorder before the age of 30.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Hypothesis 1 - that AF is more common in persons with a large cumulative exposure to endurance exercise training – requires an older cohort to ensure adequate power. Using Australian community AF prevalence estimates of 5.35% - 9%2,39, a conservative 2-fold estimate of relative risk (ie. 3.6 vs 7.2% prevalence), ß=0.8 and a=0.05 and 2:1 sampling, a sample size of 328 subjects is required. Thus, our planned cohort of 360 subjects (240 athletes and 120 referents in this age group) is adequately powered to address a clinically relevant excess of AF.
The first stage of the study employs a within subject repeated measures design whereby it is hypothesized that atrial size will increase with two years of intense endurance training, but not in untrained controls. The sample size of 135 subjects is derived from the fact that 120 subjects provides adequate power to detect a 10% increase in atrial size from 34 ±9 ml/m2 (from our previous data), ß =0.8, a = 0.05. The same sample size is used for the retiring athlete cohort as this should be adequately powered to detect reverse remodelling of similar magnitude. In the retired athlete cohort, repeat assessment of atrial remodelling will be replaced by serial assessments for incident AF and electrophysiological studies where clinically indicated.
Summary: 90 young athletes (45 controls), 90 retiring athletes (45 controls), 240 older athletes and 120 controls. Total: 630 subjects

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/02/2017
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
630
Accrual to date
123
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 10778 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment hospital [2] 10779 0
South Australian Health and Medical Research Institute (SAHMRI) - Adelaide
Recruitment postcode(s) [1] 22516 0
3004 - Melbourne
Recruitment postcode(s) [2] 22517 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 10344 0
Belgium
State/province [1] 10344 0
Antwerp and Brabant

Funding & Sponsors
Funding source category [1] 297406 0
Government body
Name [1] 297406 0
This research has been funded by the National Health and Medical Research Council of Australia (Grant # APP1130353).
Country [1] 297406 0
Australia
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
99 Commercial road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 296396 0
None
Name [1] 296396 0
Address [1] 296396 0
Country [1] 296396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298511 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 298511 0
Ethics committee country [1] 298511 0
Australia
Date submitted for ethics approval [1] 298511 0
27/10/2016
Approval date [1] 298511 0
12/12/2016
Ethics approval number [1] 298511 0
HREC/16/Alfred156

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

Contacts
Principal investigator
Name 77310 0
A/Prof Andre La Gerche
Address 77310 0
Baker Heart and Diabetes Institute
Alfred Centre, level 4
99 Commercial Road
Melbourne
VIC 3004
Country 77310 0
Australia
Phone 77310 0
+61 3 8532 1111
Fax 77310 0
Email 77310 0
[email protected]
Contact person for public queries
Name 77311 0
Kristel Janssens
Address 77311 0
Baker Heart and Diabetes Institute
Alfred Centre, level 4
99 Commercial Road
Melbourne
VIC 3004
Country 77311 0
Australia
Phone 77311 0
+61 3 8532 1169
Fax 77311 0
Email 77311 0
[email protected]
Contact person for scientific queries
Name 77312 0
Andre La Gerche
Address 77312 0
Baker Heart and Diabetes Institute
Alfred Centre, level 4
99 Commercial Road
Melbourne
VIC 3004
Country 77312 0
Australia
Phone 77312 0
+61 3 8532 1111
Fax 77312 0
Email 77312 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseDiffering mechanisms of atrial fibrillation in athletes and non-athletes: alterations in atrial structure and function.2020https://dx.doi.org/10.1093/ehjci/jeaa183
N.B. These documents automatically identified may not have been verified by the study sponsor.