Athlete HeartPro@HeartNCT05164328
Prospective Athlete's Heart Study
An observational study of Athlete Heart, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Athlete Heart
- How many people
- 450 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 23 Jun 2015to 23 Jun 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Medical history of cardiovascular disease
- Current smoker of past history of smoking
- Diabetes mellitus
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Guido Claessen, Prof. Dr. contact
4 sites in 2 countries
Belgium3 sites, 3 recruiting
- Recruiting
UZ Antwerpen
Edegem, Antwerp, 2650
Hein Heidbuchel, Prof. Dr., heinheid@gmail.com
Caroline Van De Heyning, Prof. Dr., Caroline.VanDeHeyning@uza.be
- Recruiting
Jessa Ziekenhuis Hasselt
Hasselt, Limburg, 3500
Lieven Herbots, Dr., lieven.herbots@jessazh.be
Olivier Ghekiere, Dr., Olivier.Ghekiere@jessazh.be
- Recruiting
UZ Leuven
Leuven, Vlaams Brabants, 3000
Guido Claessen, Prof. Dr., guido.claessen@uzleuven.be
Rik Willems, Prof. Dr., rik.willems@uzleuven.be
Australia1 site, 1 recruiting
- Recruiting
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
K Janssens, Kristel.Janssens@baker.edu.au
Andre La Gerche, Prof. Dr., Andre.Lagerche@baker.edu.au
About this study
Official title: Prospective Athlete's Heart Study: Long-term Assessment of the Determinants of Cardiac Remodelling and Its Clinical Consequences in Endurance Athletes
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.
- Conditions
- Athlete Heart
- Being tested
- No intervention
- Keywords
- Athlete, Atrial fibrillation, Arrhythmias, Cardiac remodelling, Cardiomyopathy, Genetics
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype
Rare and common variants in cardiomyopathy associated genes
Measured: Baseline
Training load
Duration and intensity of training
Measured: Baseline to 20 years
Atrial fibrillation
Measured: Baseline to 20 years
Ventricular arrhythmias
Ventricular ectopic beats, non-sustained and sustained ventricular tachycardia
Measured: Baseline to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start23 Jun 2015
- Primary completion23 Jun 2035 (estimated)
- Study completion23 Jun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athlete HeartStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Baker Heart and Diabetes Institute, Victor Chang Cardiac Research Institute, University Hospital, Antwerp, Jessa Hospital
- Responsible party
- Principal investigator, dr. Guido Claessen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Guido Claessen, Prof. Dr., Study chair, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164328
- Sponsor's protocol ID
- 57241
- Acronym
- Pro@Heart
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35368514
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Athlete's Heart Study: Long-term Assessment of the Determinants of Cardiac Remodelling and Its Clinical Consequences in Endurance Athletes
- ClinicalTrials.gov ID
- NCT05164328
- Acronym / sponsor ID
- Pro@Heart / 57241
- Conditions
- Athlete Heart
- Keywords
- Athlete, Atrial fibrillation, Arrhythmias, Cardiac remodelling, Cardiomyopathy, Genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Baker Heart and Diabetes Institute, Victor Chang Cardiac Research Institute, University Hospital, Antwerp, Jessa Hospital
- Study start
- 23 Jun 2015 (actual)
- Primary completion
- 23 Jun 2035 (estimated)
- Study completion
- 23 Jun 2040 (estimated)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletes | – | Other: No intervention1. 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 | – | Other: No intervention1. Males and females aged 14-23 years old 2. Non athletes engaged in < 3 hours per week of physical activity |
Who may qualify
- Ages
- 14 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Non athletes engaged in < 3 hours per week of physical activity
Key exclusion criteria (3 listed)
- Medical history of cardiovascular disease
- Current smoker of past history of smoking
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Athletes, Non-athletes |
Primary outcome
Genotype
Time frame: Baseline
Rare and common variants in cardiomyopathy associated genes
Training load
Time frame: Baseline to 20 years
Duration and intensity of training
Atrial fibrillation
Time frame: Baseline to 20 years
Ventricular arrhythmias
Time frame: Baseline to 20 years
Ventricular ectopic beats, non-sustained and sustained ventricular tachycardia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Derived from this study: PubMed 35368514De 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.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Role of CMR-FT in Assessment of HCM and Athlete's Heart.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guido Claessen, Prof. Dr. contact
Guido Claessen, Prof. Dr. study chair
UZ Leuven
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athlete Heart, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guido Claessen, Prof. Dr. (guido.claessen@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotype (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021; AzTrials last refreshed its copy on 28 Oct 2026.