Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000716268
Ethics application status
Approved
Date submitted
24/04/2018
Date registered
1/05/2018
Date last updated
29/05/2025
Date data sharing statement initially provided
1/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Prospective Athlete Heart Study- elucidating genetic determinants of cardiac remodelling using endurance exercise as an environmental stress.
Scientific title
The Prospective Athlete Heart Study- elucidating genetic determinants of cardiac remodelling using endurance exercise as an environmental stress.
Secondary ID [1] 294706 0
None
Universal Trial Number (UTN)
U1111_1212_8349
Trial acronym
Pro@Heart
Linked study record
ACTRN12618000711213

Health condition
Health condition(s) or problem(s) studied:
Cardiac Remodelling 307567 0
Athlete's Heart 307568 0
Heart Failure 307569 0
Genetics 307571 0
Cardiac arrythmia's 307572 0
Condition category
Condition code
Cardiovascular 306641 306641 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
A prospective comparison of endurance athletes and non-athletes which will assess the primary hypothesis that rare variants in 24 genes associated with abnormalities of cardiac structure will be more prevalent in those athletes with the greatest cardiac remodelling after 2 years of intense endurance exercise training.
All subjects will undergo detailed assessment of cardiac structure and exercise capacity at baseline, after two years, 5 years and every 5 years after that for 25 years total.
Testing will include, anthropometry measures (height, weight, BP), echocardiogram, electrocardiogram, 24h holter monitoring, Cardiac Magnetic Resonance Imaging with exercise, VO2 max test, 12 month exercise diary, blood samples, Dexa scan.
Selection for genotyping after 2 years.
Intervention code [1] 300999 0
Diagnosis / Prognosis
Comparator / control treatment
Endurance exercise represents the ideal model for testing genetic–environmental interactions. Therefore endurance athletes will be compared to a non-athletic control group.
Control group
Active

Outcomes
Primary outcome [1] 305638 0
Rare genetic variants will be identified that are associated with LV eccentric hypertrophy, using a custom cardiomyopathy panel of 24 genes. This will enable us to identify individuals at greater risk of cardiac events in whom preventative therapies may be of greatest benefit.
Timepoint [1] 305638 0
2 years after baseline testing
Primary outcome [2] 305641 0
left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (CMR)
Timepoint [2] 305641 0
2 years after baseline testing
Secondary outcome [1] 346005 0
To compare athletic cardiac remodelling (cardiac mass and geometry). This will be quantified as LV and RV volumes and myocardial mass with cardiac magnetic resonance imaging (CMR). Cardiac fibrosis will be measured post gadolinium enhancement. The extent and range of exercise induced cardiac remodelling will be defined in a rigorous prospective manner, by measuring and comparing non-athletes with athletes.
Timepoint [1] 346005 0
baseline, 2 years
Secondary outcome [2] 346007 0
Assess fitness status by VO2 max (measurement of maximum oxygen metabolism) test on bicycle ergometer with metabolic cart
Timepoint [2] 346007 0
baseline, two years, 5 years and every 5 years after that for 25 years.
Secondary outcome [3] 346137 0
Assess the prevalence of cardiac arrhythmia's on electrocardiogram and 24h holter monitoring
Timepoint [3] 346137 0
baseline, two years, 5 years and every 5 years after that for 25 years
Secondary outcome [4] 346139 0
Assessment of myocardial fibrosis using T1-weighted inversion recovery times on cardiac MRI
Timepoint [4] 346139 0
Baseline and 2 years
Secondary outcome [5] 346140 0
Measurement of torsion, strain and strain rate using transthoracic echocardiogram, including Doppler and 3D volumetric acquisitions.
Timepoint [5] 346140 0
baseline, 2 years
Secondary outcome [6] 346141 0
Blood samples to measure fasting lipid profile, cardiac biomarkers (Troponin I, Brain Natriuretic Peptide), Hs_CRP, FBE and U&E.
Timepoint [6] 346141 0
baseline, two years
Secondary outcome [7] 346142 0
Resting blood pressure and blood pressure response during exercise measured in office after lying supine for 10 minutes and during the VO2 max test
Timepoint [7] 346142 0
baseline, 2 years
Secondary outcome [8] 346144 0
Measurement of body composition and bone mineral density by a dual energy X-ray absorptiometry (DEXA) scan (whole body, spine and hip scan)
Timepoint [8] 346144 0
baseline, two years.
Secondary outcome [9] 346147 0
Quantify exercise duration and intensity during one week from self-report on an exercise diary or by recording on an electronic fitness device
Timepoint [9] 346147 0
baseline, two years

Eligibility
Key inclusion criteria
Endurance athletes, male and female, aged 16-23 years, competing in endurance sports in which aerobic fitness conditioning is a principal component of performance. Aiming to be involved in competition and high level training for more than 5 years.
Non-athletes, male and female, aged 16-23 years, less than 2 hours of endurance activity per week, not competing in an endurance sport, not enrolled in a fitness program to improve fitness.
Minimum age
16 Years
Maximum age
23 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Known cardiovascular disease
- Cigarette smoking (current or previous)
- Moderate or severe hypertension.
- Use of performance enhancing drugs.
- A contraindication to magnetic resonance imaging

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Prospective exercise cohort (320 athletes; 220 males, 100 females)
Non-athletic controls (110 males, 50 females)
The reason for recruiting a cohort of approximately two-thirds male is a pragmatic balance between opportunities for recruitment, given greater male participation in endurance sport, balanced against the opportunity to provide female athletic data which is under-represented in the scientific literature.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/05/2016
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2050
Actual
Sample size
Target
480
Accrual to date
158
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 10780 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment hospital [2] 10781 0
South Australian Health and Medical Research Institute (SAHMRI) - Adelaide
Recruitment hospital [3] 27989 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 22518 0
3004 - Melbourne
Recruitment postcode(s) [2] 22519 0
5000 - Adelaide
Recruitment postcode(s) [3] 44186 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 10351 0
Belgium
State/province [1] 10351 0
Antwerp, Brabant

Funding & Sponsors
Funding source category [1] 299311 0
Government body
Name [1] 299311 0
NHMRC APP1109322
Country [1] 299311 0
Australia
Funding source category [2] 299315 0
Charities/Societies/Foundations
Name [2] 299315 0
National Heart Foundation
Country [2] 299315 0
Australia
Primary sponsor type
Other
Name
St. Vincent's Institute of Medical Research
Address
99 Commercial Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 298580 0
None
Name [1] 298580 0
Address [1] 298580 0
Country [1] 298580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300221 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 300221 0
Ethics committee country [1] 300221 0
Australia
Date submitted for ethics approval [1] 300221 0
23/07/2015
Approval date [1] 300221 0
21/10/2015
Ethics approval number [1] 300221 0
333/15

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

Contacts
Principal investigator
Name 82962 0
A/Prof Andre La Gerche
Address 82962 0
St Vincent's Institute of Medical Research, 9 Princes Street Fitzroy Victoria Australia 3065
Country 82962 0
Australia
Phone 82962 0
+61 3 9231 2480
Fax 82962 0
Email 82962 0
[email protected]
Contact person for public queries
Name 82963 0
Kristel Janssens
Address 82963 0
St Vincent's Institute of Medical Research, 9 Princes Street Fitzroy Victoria Australia 3065
Country 82963 0
Australia
Phone 82963 0
+61 3 9231 2480
Fax 82963 0
Email 82963 0
[email protected]
Contact person for scientific queries
Name 82964 0
Andre La Gerche
Address 82964 0
St Vincent's Institute of Medical Research, 9 Princes Street Fitzroy Victoria Australia 3065
Country 82964 0
Australia
Phone 82964 0
+61 3 9231 2480
Fax 82964 0
Email 82964 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
SourceTitleYear of PublicationDOI
EmbaseRationale and design of the PROspective ATHletic Heart (Pro@Heart) study: Long-term assessment of the determinants of cardiac remodelling and its clinical consequences in endurance athletes.2022https://dx.doi.org/10.1136/bmjsem-2022-001309
N.B. These documents automatically identified may not have been verified by the study sponsor.