ANZCTR - Registration

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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]

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

Athlete's heart

Atrial remodeling

Condition category

Condition code

Cardiovascular

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]

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]

Presence of atrial fibrillation assessed by electrocardiogram and holter monitoring

Timepoint [1]

Comparison between athletic and non-athletic cohorts at baseline testing

Primary outcome [2]

Assessment of atrial structure on Cardiac Magnetic Resonance Imaging and echocardiogram

Timepoint [2]

Comparison of the age groups at baseline and after 2 years.

Secondary outcome [1]

Fitness status assessed by a VO2 max test with a continuous ramp protocol on a bike ergometer and metabolic chart

Timepoint [1]

At baseline testing and after 2 years

Secondary outcome [2]

Cardiac markers, BNP, Troponin and fasting lipid profile assessed by a blood test

Timepoint [2]

Baseline testing and 2 years after

Secondary outcome [3]

Assessment of exercise training by recording daily exercise activities on a 7-day training diary or by electronic recording on TrainingPeaks

Timepoint [3]

At baseline recorded for 1 week

Secondary outcome [4]

assessment of cardiovascular risk factors and medical history using a questionnaire

Timepoint [4]

At baseline

Secondary outcome [5]

Assessment of body composition and bone mineral density using a DEXA scanner

Timepoint [5]

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]

Baker Heart and Diabetes Institute - Melbourne

Recruitment hospital [2]

South Australian Health and Medical Research Institute (SAHMRI) - Adelaide

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

5000 - Adelaide

Recruitment outside Australia

Country [1]

Belgium

State/province [1]

Antwerp and Brabant

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

This research has been funded by the National Health and Medical Research Council of Australia (Grant # APP1130353).

Address [1]

Australian Government
National Health and Medical Research Council
Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Other

Name

Baker Heart and Diabetes Institute

Address

99 Commercial road
Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/10/2016

Approval date [1]

12/12/2016

Ethics approval number [1]

HREC/16/Alfred156

Summary

Brief summary

Atrial fibrillation (AF) is the most common sustained heart rhythm problem that increases the chance of stroke and heart failure and currently represents a growing socioeconomic burden in our ageing population. Amongst the established risk factors of age, hypertension and diabetes, exercise is increasingly recognised as a powerful modulator of AF risk.  
Low and moderate intensity exercise is an important therapy in the prevention and treatment of AF but, at the other end of the spectrum, intense endurance exercise has been associated with a 5-fold increase in AF risk. The reasons for this excess are not known but may relate to the profound atrial remodelling that occurs with endurance athletic training.
The rate at which AF occurs in retired elite endurance athletes will be compared with non-athletes who are matched for health status, age and gender.
We will assess the extent to which exercise-induced changes in heart shape, function and electrical properties represent a short-term or permanent process. This will be assessed by comparing three groups: (1) young athletes adapting to elite training, (2) middle-aged athletes during end of career detraining, and (3) retired athletes with more than 10 years of competition at national or international level. A group of athletes with arrhythmias will also provide a meaningful comparison group to determine which characteristics are shared amongst groups.
To study the changes in heart structure and function we will use the latest echocardiographic and cardiac magnetic resonance imaging techniques.
The study is being conducted by a team of researchers at the Baker Heart and Diabetes Institute, the South Australian Health and Medical Institute and a research team in Belgium led by A/Professor Andre La Gerche.

Trial website

https://www.baker.edu.au/research/clinical-trials/pro-af-trial

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Andre La Gerche

Address

Baker Heart and Diabetes Institute
Alfred Centre, level 4
99 Commercial Road
Melbourne
VIC 3004

Country

Australia

Phone

+61 3 8532 1111

Fax

andre.lagerche@baker.edu.au

Contact person for public queries

Name

Kristel Janssens

Address

Baker Heart and Diabetes Institute
Alfred Centre, level 4
99 Commercial Road
Melbourne
VIC 3004

Country

Australia

Phone

+61 3 8532 1169

Fax

kristel.janssens@baker.edu.au

Contact person for scientific queries

Name

Andre La Gerche

Address

Baker Heart and Diabetes Institute
Alfred Centre, level 4
99 Commercial Road
Melbourne
VIC 3004

Country

Australia

Phone

+61 3 8532 1111

Fax

andre.lagerche@baker.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Differing mechanisms of atrial fibrillation in athletes and non-athletes: alterations in atrial structure and function.	2020	https://dx.doi.org/10.1093/ehjci/jeaa183

N.B. These documents automatically identified may not have been verified by the study sponsor.

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