NCT05164328

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 Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
172mo left

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jun 2015Jun 2040

Study Start

First participant enrolled

June 23, 2015

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2035

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2040

Last Updated

December 20, 2021

Status Verified

December 1, 2021

Enrollment Period

20 years

First QC Date

December 7, 2021

Last Update Submit

December 7, 2021

Conditions

Athlete Heart

Keywords

AthleteAtrial fibrillationArrhythmiasCardiac remodellingCardiomyopathyGenetics

Outcome Measures

Primary Outcomes (4)

  • Genotype

    Rare and common variants in cardiomyopathy associated genes

    Baseline

  • Training load

    Duration and intensity of training

    Baseline to 20 years

  • Atrial fibrillation

    Baseline to 20 years

  • Ventricular arrhythmias

    Ventricular ectopic beats, non-sustained and sustained ventricular tachycardia

    Baseline to 20 years

Study Arms (2)

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

Other: No intervention

Non-athletes

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

Other: No intervention

Interventions

No interventionOTHER

No intervention

AthletesNon-athletes

Eligibility Criteria

Age14 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Males and females aged 14-23 years old
  • Athletes competing in endurance sports at national or international level for at least 2 years. Sports include:
  • Triathlon
  • Cycling
  • Distance running (≥ 1500 meters)
  • Rowing
  • Swimming
  • Non athletes engaged in \< 3 hours per week of physical activity

You may not qualify if:

  • Medical history of cardiovascular disease
  • Current smoker of past history of smoking
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

UZ Antwerpen

Edegem, Antwerp, 2650, Belgium

RECRUITING

Jessa Ziekenhuis Hasselt

Hasselt, Limburg, 3500, Belgium

RECRUITING

UZ Leuven

Leuven, Vlaams Brabants, 3000, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35368514DERIVED

Related Links

MeSH Terms

Conditions

Atrial FibrillationArrhythmias, CardiacCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guido Claessen, Prof. Dr.

    UZ Leuven

    STUDY CHAIR

Central Study Contacts

Guido Claessen, Prof. Dr.

CONTACT

guido.claessen@uzleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 20, 2021

Study Start

June 23, 2015

Primary Completion (Estimated)

June 23, 2035

Study Completion (Estimated)

June 23, 2040

Last Updated

December 20, 2021

Record last verified: 2021-12

Locations

AU(1)BE(3)