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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05164328




Registration number
NCT05164328
Ethics application status
Date submitted
7/12/2021
Date registered
20/12/2021
Date last updated
20/12/2021

Titles & IDs
Public title
Prospective Athlete's Heart Study
Scientific title
Prospective Athlete's Heart Study: Long-term Assessment of the Determinants of Cardiac Remodelling and Its Clinical Consequences in Endurance Athletes
Secondary ID [1] 0 0
57241
Universal Trial Number (UTN)
Trial acronym
Pro@Heart
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Athlete Heart 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

Athletes - 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

Non-athletes - 1. Males and females aged 14-23 years old
2. Non athletes engaged in \< 3 hours per week of physical activity


Other interventions: No intervention
No intervention
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Genotype
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Training load
Timepoint [2] 0 0
Baseline to 20 years
Primary outcome [3] 0 0
Atrial fibrillation
Timepoint [3] 0 0
Baseline to 20 years
Primary outcome [4] 0 0
Ventricular arrhythmias
Timepoint [4] 0 0
Baseline to 20 years

Eligibility
Key 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
Minimum age
14 Years
Maximum age
23 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical history of cardiovascular disease
2. Current smoker of past history of smoking
3. Diabetes mellitus

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/06/2040
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Limburg
Country [3] 0 0
Belgium
State/province [3] 0 0
Vlaams Brabants

Funding & Sponsors
Primary sponsor type
Other
Name
Universitaire Ziekenhuizen KU Leuven
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Baker Heart and Diabetes Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Victor Chang Cardiac Research Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University Hospital, Antwerp
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Jessa Hospital
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05164328
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Guido Claessen, Prof. Dr.
Address 0 0
UZ Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Guido Claessen, Prof. Dr.
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05164328