Clinical trial NCT05164328: Prospective Athlete's Heart Study
Official title: Prospective Athlete's Heart Study: Long-term Assessment of the Determinants of Cardiac Remodelling and Its Clinical Consequences in Endurance Athletes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Athlete Heart
Keywords: Athlete
Atrial fibrillation
Arrhythmias
Cardiac remodelling
Cardiomyopathy
Genetics
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Baker Heart and Diabetes Institute
name: Victor Chang Cardiac Research Institute
name: University Hospital, Antwerp
name: Jessa Hospital
First posted: 2021-12-20
Enrollment: 450
Sex: ALL
Minimum age (years): 14
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Athletes aged 14 to 23 years recruited from elite endurance sports programs and organisations including Cycling Vlaanderen, Triatlon Vlaanderen, Belgian Cycling, Cycling Australia, Rowing Australia and Athletics Australia and from sports performance centres including Nottebohm Antwerpen, Bakala Academy Leuven and Adlon Hasselt. Volunteers recruited by means of 'word of mouth' and social media campaigns within elite endurance sporting circles. Non-athletes consist of age and gender matched university and college students recruited from Australian and Belgian universities in addition to social media campaigns.

Brief summary: The Pro@Heart (Prospective Athlete's Heart) study is an international multicentre long-term prospective trial. The primary objective of the Pro@Heart study is to investigate the impact of training load (i.e. accurately evaluated in term of type, frequency, duration and intensity) and genotype on the variability of structural, functional and electrical exercise induced cardiac remodeling (EICR) in young competitive endurance athletes. The second objective is to determine how EICR, training load and genotype are associated with physical performance, health benefits and cardiac pathology (e.g. exercise-related cardiomyopathies and arrhythmias) during follow-up over several decades.


Eligibility criteria: Inclusion Criteria:

1. Males and females aged 14-23 years old
2. Athletes competing in endurance sports at national or international level for at least 2 years. Sports include:

   1. Triathlon
   2. Cycling
   3. Distance running (≥ 1500 meters)
   4. Rowing
   5. Swimming
3. Non athletes engaged in \< 3 hours per week of physical activity

Exclusion Criteria:

1. Medical history of cardiovascular disease
2. Current smoker of past history of smoking
3. Diabetes mellitus

Primary outcomes:
measure: Genotype
timeFrame: Baseline
measure: Training load
timeFrame: Baseline to 20 years
measure: Atrial fibrillation
timeFrame: Baseline to 20 years
measure: Ventricular arrhythmias
timeFrame: Baseline to 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerp
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis Hasselt
state: Limburg
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabants
Study officials:
affiliation: UZ Leuven
name: Guido Claessen, Prof. Dr.
role: STUDY_CHAIR
References:
citation: De Bosscher R, Dausin C, Janssens K, Bogaert J, Elliott A, Ghekiere O, Van De Heyning CM, Sanders P, Kalman J, Fatkin D, Herbots L, Willems R, Heidbuchel H, La Gerche A, Claessen G; Pro@Heart Consortium. Rationale 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. BMJ Open Sport Exerc Med. 2022 Mar 18;8(1):e001309. doi: 10.1136/bmjsem-2022-001309. eCollection 2022.