The Prospective Athlete Heart Study- elucidating genetic determinants of cardiac remodelling using endurance exercise as an environmental stress.

• Register: ANZCTR
• Last refreshed on: 7 September 2020
• Main ID: ACTRN12618000716268
• Date of registration: 01/05/2018
• Prospective Registration: No
• Primary sponsor: Baker Heart and Diabetes Institute
• 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.
• Date of first enrolment: 23/05/2016
• Target sample size: 480
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000716268.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia, Belgium

Contacts

• Name: Ms Kristel Janssens

• Name: A/Prof Andre La Gerche

Key inclusion & exclusion criteria

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.
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


Age minimum: 16 Years
Age maximum: 23 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiac Remodelling;Athlete's Heart;Heart Failure;Genetics;Cardiac arrythmia's;
Cardiac Remodelling
Athlete's Heart
Heart Failure
Genetics
Cardiac arrythmia's

Cardiovascular - Normal development and function of the cardiovascular system

Intervention(s)

A prospective comparison of endurance athletes and non-athletes which will assess the primary hypothesis that rare variants in 65 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 25years 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.

Primary Outcome(s)

Assess the prevalence of rare variants in cardiac structural genes relative to Left Ventricular Mass index in endurance athletes and non-athletes by performing next generation sequencing in 65 cardiac genes extracting DNA from circulating white cells.[2 years after baseline testing]

left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (CMR) [2 years after baseline testing]

Secondary Outcome(s)

Blood samples to measure fasting lipid profile, cardiac biomarkers (Troponin I, Brain Natriuretic Peptide), Hs_CRP, FBE and U&E.[baseline, two years]

Measurement of torsion, strain and strain rate using transthoracic echocardiogram, including Doppler and 3D volumetric acquisitions.[baseline, 2 years]

Measurement of body composition and bone mineral density by a dual energy X-ray absorptiometry (DEXA) scan (whole body, spine and hip scan)[baseline, two years.]

Assessment of myocardial fibrosis using T1-weighted inversion recovery times on cardiac MRI[Baseline and 2 years]

Resting blood pressure and blood pressure response during exercise measured in office after lying supine for 10 minutes and during the VO2 max test[baseline, 2 years]

Assess fitness status by VO2 max (measurement of maximum oxygen metabolism) test on bicycle ergometer with metabolic cart[baseline, two years, 5 years and every 5 years after that for 25 years.]

Assess the changes in cardiac structure (cardiac mass and geometry) by measurement of LV and RV volumes and myocardial mass using cardiac magnetic resonance (CMR) with gadolinium contrast[baseline, 2 years]

Assess the prevalence of cardiac arrhythmia's on electrocardiogram and 24h holter monitoring [baseline, two years, 5 years and every 5 years after that for 25 years]

Quantify exercise duration and intensity during one week from self-report on an exercise diary or by recording on an electronic fitness device [baseline, two years]

Secondary ID(s)

None

Source(s) of Monetary Support

National Heart Foundation

NHMRC APP1109322

Ethics review

Status: Approved
Approval date: 21/10/2015
Contact:

Alfred Hospital Ethics Committee