Coronary Artery DiseaseMASTER@HEARTNCT03711539
Lifetime Endurance Exercise to Prevent Coronary Artery Disease
An observational study of Coronary Artery Disease and Physical Activity, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial summary
The primary objective of the Master@Heart Trial is to investigate whether lifelong endurance exercise reduces the incidence of non-calcified plaques (both mixed and soft plaques) as compared to late-onset endurance exercise and a non-athletic lifestyle. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Physical Activity, Lifestyle
- How many people
- 1,800 participants
- Where
- 3 sitesBelgium
- Study dates
- 18 Oct 2018to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort 1: Lifelong endurance athletes. Inclusions: Athletes who have initiated endurance sports activities at regional, national or international level before the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. Cohort 2: Late-onset endurance athletes. Athletes who have initiated endurance sports activities at regional, national or international level after the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. Cohort 3: Healthy non-athletes will be recruited from subjects seen in the outpatient clinic for a work-related medical check-up, from university alumni and from multisports organisations. Participation in regular sports with a low dynamic component (e.g. billiards, darts or bowling) >3 hours /week is allowed.
Who may be able to join
- Lifelong endurance athletes:
- Initiation of endurance sports before the age of 30 years
- Activities at regional, national or international level
- Sports: triathlon, cycling, distance running (1500 metres and longer) and rowing
- Aged 45-70 years
- Involved in competition and high-level training:
Show all 22Show fewer
- more than 10 hours per week for cyclists and triathletes
- more than 6 hours per week for runners and rowers.
- Late-onset endurance athletes:
- Initiation of endurance sports after the age of 30 years and at least 6 months ago
- Activities at regional, national or international level
- Sports: triathlon, cycling, distance running (1500 metres and longer) and rowing
- Aged 45-70 years
- Involved in competition and high-level training:
- more than 10 hours per week for cyclists and triathletes
- more than 6 hours per week for runners and rowers.
- Healthy non-athletes
- subjects seen in the outpatient clinic for a work-related medical check-up
- university alumni
- subjects from multisports organisations
- history of regular sports practice <3 hours /week
- participation in regular sports with a low dynamic component (e.g. billiards, darts or bowling) >3 hours /week is allowed
Who cannot join
- history of smoking (> 5 pack years)
- history of diabetes
- diagnosis of cardiopulmonary disorder prior to inclusion
- medical treatment for arterial hypertension or hypercholesterolemia
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Recruiting
University Hospital, Antwerpen
Edegem, 2650
Hein Heidbuchel, MD, PhD, +3238214693, hein.heidbuchel@uantwerpen.be
- Recruiting
Jessa Hospital
Hasselt, 3500
Lieven Herbots, MD, PhD, +3211373565, lieven.herbots@jessazh.be
- Recruiting
UZLeuven
Leuven, 3000
Guido Claessen, MD, PhD, +3216343397, guido.claessen@uzleuven.be
About this study
Official title: Lifetime Endurance Exercise to Prevent Coronary Artery Disease. A Comparison With Late-onset Endurance Training and a Sedentary Lifestyle
The primary objective of the Master@Heart Trial is to investigate whether lifelong endurance exercise reduces the incidence of non-calcified plaques (both mixed and soft plaques) as compared to late-onset endurance exercise and a non-athletic lifestyle.
Read the detailed description
Cardiovascular disease remains the leading cause of death in Europe and is strongly related to a sedentary lifestyle combined with inadequate dietary habits and the prevalence of smoking. In parallel with this modern inactivity pandemic, the past 2 decades we have also witnessed an increase in the number of middle-aged and older individuals engaging in competitive sports and mass exercise events, such as marathon-running and cycling events. This increasing popularity of endurance sports implies that a greater proportion of individuals participating in high-intensity sport will have a higher cardiovascular risk profile. Coronary artery disease is by far the most common cause of sudden cardiac death in senior athletes, accounting for >75% of all cardiac deaths during exercise. Each case of sudden cardiac death is always a dramatic event and is often widely publicized in the media, thereby raising issues and questions regarding the safety of intense sports participation. Debate and uncertainty persist with much speculation filling the space left by an incomplete understanding of the exercise dose-response relationship. In view of the importance of exercise for healthy ageing, it is important to identify and eliminate any adverse associations with exercise so that everyone can enjoy the benefits of exercise. Until present, no studies have compared the 'standard of care,' which includes a healthy diet, abstinence from smoking, and regular moderate exercise, with and without the addition of larger doses of endurance exercise. Furthermore, it remains unknown whether the age of onset of endurance training influences its potential preventive and adverse effects.
Until present, no studies have compared the 'standard of care,' which includes a healthy diet, abstinence from smoking, and regular moderate exercise, with and without the addition of long-term endurance exercise. In this multicentre project we will investigate the beneficial effects of long-term endurance exercise for the prevention of coronary and carotid artery disease and its potential adverse effects, such as an increased incidence of atrial fibrillation and myocardial fibrosis. We will recruit 3 age-matched cross-sectional cohorts: (1) lifelong endurance athletes engaged in regular endurance sports practice since the age of 30 years, (2) late-onset endurance athletes who have initiated endurance sports activities after the age of 30 years and (3) non-athletic individuals. Only male subjects will be included given the much lower prevalence of ischemic heart disease amongst female athletes.
- Conditions
- Coronary Artery Disease, Physical Activity, Lifestyle
- Keywords
- Endurance Exercise, Coronary Artery Disease, Atrial Fibrillation, Myocardial Fibrosis, Coronary CT
- Medical subject headings
- Coronary Artery Disease, Motor Activity, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lifelong Endurance Athletes | i) Athletes who have initiated endurance sports activities at regional, national or international level before the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. ii) Aged 45-70 years. iii) Involved in competition and high-level training: more than 10 hours per week for cyclists and triathletes or more than 6 hours per week for runners and rowers. Subjects will be excluded if: i) they have a history of smoking (> 5 pack years) or diabetes, ii) had been diagnosed with a cardiopulmonary disorder prior to inclusion. | |
| Late-onset Endurance Athletes | i) Athletes who have initiated endurance sports activities at regional, national or international level after the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. ii) Aged 45-70 years. iii) Involved in competition and high-level training: more than 10 hours per week for cyclists and triathletes or more than 6 hours per week for runners and rowers. Subjects will be excluded if: i) they have a history of smoking (> 5 pack years) or diabetes, ii) they have a history of smoking (> 5 pack years) or diabetes, ii) had been diagnosed with a cardiopulmonary disorder prior to inclusion. | |
| Healthy Non-athletes | Healthy non-athletes will be recruited from subjects seen in the outpatient clinic for a work-related medical check-up, from university alumni and from multisports organisations. Subjects will be excluded if they: i) had been involved in regular sports practice more than >3 hours / week, ii) have a history of smoking (> 5 pack years) or diabetes, or iii) had been diagnosed with a cardiopulmonary disorder prior to inclusion. Participation in regular sports with a low dynamic component (e.g. billiards, darts or bowling) >3 hours /week is allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Non-calcified Plaques
Incidence of non-calcified plaques (both mixed and soft plaques) assessed by Coronary CT in lifelong endurance athletes as compared to late-onset endurance athletes and non-athletic subjects.
Measured: 2 years
Secondary outcomes (2)
Incidence of Atrial Fibrillation
To assess the association between the (a) amount and (b) starting age of lifelong endurance sports and atrial fibrillation assessed by Holter monitoring
Measured: 4 years
Prevalence of Myocardial Fibrosis
To assess the association between the (a) amount and (b) starting age of lifelong endurance sports and myocardial fibrosis assessed by cardiac magnetic resonance imaging
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start18 Oct 2018
- Primary completion1 Oct 2021
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Jessa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711539
- Sponsor's protocol ID
- S61336
- Acronym
- MASTER@HEART
- Status last verified
- Jul 2024
- First submitted
- 17 Oct 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pauwels R, Dausin C, Ruiz-Carmona S, De Bosscher R, De Paepe J, Bekhuis Y, Delpire B, Sinnaeve P, Dymarkowski S, Ghekiere O, Bruckers L, Kuznetsova T, Van De Heyning CM, Van Herck PL, Eijsvogels TMH, Herbots L, Robyns T, La Gerche A, Heidbuchel H, Willems R, Claessen G; Master@Heart Consortium. Wearable-Derived Training Load and Coronary Atherosclerosis in Middle-Aged and Older Athletes and Physically Active Controls: A New Perspective From the Master@Heart Study. Circulation. 2026 Apr 7;153(14):1009-1022. doi: 10.1161/CIRCULATIONAHA.125.077117. Epub 2026 Jan 29.
PubMed 41608826Janssens K, Foulkes SJ, Mitchell AM, Dausin C, Van Soest S, Spencer L, Rowe SJ, D'Ambrosio P, Elliott AD, Van Puyvelde T, Parr EB, Willems R, Heidbuchel H, Claessen G, La Gerche A. Blood pressure response to graded bicycle exercise in males and females across the age and fitness spectrum. Eur J Prev Cardiol. 2025 Jan 6;32(1):43-51. doi: 10.1093/eurjpc/zwae262.
PubMed 39116385De Bosscher R, Dausin C, Claus P, Bogaert J, Dymarkowski S, Goetschalckx K, Ghekiere O, Belmans A, Van De Heyning CM, Van Herck P, Paelinck B, El Addouli H, La Gerche A, Herbots L, Heidbuchel H, Willems R, Claessen G. Endurance exercise and the risk of cardiovascular pathology in men: a comparison between lifelong and late-onset endurance training and a non-athletic lifestyle - rationale and design of the Master@Heart study, a prospective cohort trial. BMJ Open Sport Exerc Med. 2021 Apr 16;7(2):e001048. doi: 10.1136/bmjsem-2021-001048. eCollection 2021.
PubMed 33927885
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifetime Endurance Exercise to Prevent Coronary Artery Disease. A Comparison With Late-onset Endurance Training and a Sedentary Lifestyle
- ClinicalTrials.gov ID
- NCT03711539
- Acronym / sponsor ID
- MASTER@HEART / S61336
- Conditions
- Coronary Artery Disease, Physical Activity, Lifestyle
- Keywords
- Endurance Exercise, Coronary Artery Disease, Atrial Fibrillation, Myocardial Fibrosis, Coronary CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Jessa Hospital
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 18 Oct 2018 (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 primary objective of the Master@Heart Trial is to investigate whether lifelong endurance exercise reduces the incidence of non-calcified plaques (both mixed and soft plaques) as compared to late-onset endurance exercise and a non-athletic lifestyle.
Detailed description
Cardiovascular disease remains the leading cause of death in Europe and is strongly related to a sedentary lifestyle combined with inadequate dietary habits and the prevalence of smoking. In parallel with this modern inactivity pandemic, the past 2 decades we have also witnessed an increase in the number of middle-aged and older individuals engaging in competitive sports and mass exercise events, such as marathon-running and cycling events. This increasing popularity of endurance sports implies that a greater proportion of individuals participating in high-intensity sport will have a higher cardiovascular risk profile. Coronary artery disease is by far the most common cause of sudden cardiac death in senior athletes, accounting for >75% of all cardiac deaths during exercise. Each case of sudden cardiac death is always a dramatic event and is often widely publicized in the media, thereby raising issues and questions regarding the safety of intense sports participation. Debate and uncertainty persist with much speculation filling the space left by an incomplete understanding of the exercise dose-response relationship. In view of the importance of exercise for healthy ageing, it is important to identify and eliminate any adverse associations with exercise so that everyone can enjoy the benefits of exercise. Until present, no studies have compared the 'standard of care,' which includes a healthy diet, abstinence from smoking, and regular moderate exercise, with and without the addition of larger doses of endurance exercise. Furthermore, it remains unknown whether the age of onset of endurance training influences its potential preventive and adverse effects.
Until present, no studies have compared the 'standard of care,' which includes a healthy diet, abstinence from smoking, and regular moderate exercise, with and without the addition of long-term endurance exercise. In this multicentre project we will investigate the beneficial effects of long-term endurance exercise for the prevention of coronary and carotid artery disease and its potential adverse effects, such as an increased incidence of atrial fibrillation and myocardial fibrosis. We will recruit 3 age-matched cross-sectional cohorts: (1) lifelong endurance athletes engaged in regular endurance sports practice since the age of 30 years, (2) late-onset endurance athletes who have initiated endurance sports activities after the age of 30 years and (3) non-athletic individuals. Only male subjects will be included given the much lower prevalence of ischemic heart disease amongst female athletes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifelong Endurance Athletes | – | –i) Athletes who have initiated endurance sports activities at regional, national or international level before the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. ii) Aged 45-70 years. iii) Involved in competition and high-level training: more than 10 hours per week for cyclists and triathletes or more than 6 hours per week for runners and rowers. Subjects will be excluded if: i) they have a history of smoking (> 5 pack years) or diabetes, ii) had been diagnosed with a cardiopulmonary disorder prior to inclusion. |
| Late-onset Endurance Athletes | – | –i) Athletes who have initiated endurance sports activities at regional, national or international level after the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. ii) Aged 45-70 years. iii) Involved in competition and high-level training: more than 10 hours per week for cyclists and triathletes or more than 6 hours per week for runners and rowers. Subjects will be excluded if: i) they have a history of smoking (> 5 pack years) or diabetes, ii) they have a history of smoking (> 5 pack years) or diabetes, ii) had been diagnosed with a cardiopulmonary disorder prior to inclusion. |
| Healthy Non-athletes | – | –Healthy non-athletes will be recruited from subjects seen in the outpatient clinic for a work-related medical check-up, from university alumni and from multisports organisations. Subjects will be excluded if they: i) had been involved in regular sports practice more than >3 hours / week, ii) have a history of smoking (> 5 pack years) or diabetes, or iii) had been diagnosed with a cardiopulmonary disorder prior to inclusion. Participation in regular sports with a low dynamic component (e.g. billiards, darts or bowling) >3 hours /week is allowed. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: Lifelong endurance athletes. Inclusions: Athletes who have initiated endurance sports activities at regional, national or international level before the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. Cohort 2: Late-onset endurance athletes. Athletes who have initiated endurance sports activities at regional, national or international level after the age of 30 years. Sports include triathlon, cycling, distance running (1500 metres and longer) and rowing. Cohort 3: Healthy non-athletes will be recruited from subjects seen in the outpatient clinic for a work-related medical check-up, from university alumni and from multisports organisations. Participation in regular sports with a low dynamic component (e.g. billiards, darts or bowling) >3 hours /week is allowed.
Key inclusion criteria (22 listed)
- Lifelong endurance athletes:
- Late-onset endurance athletes:
- Healthy non-athletes
Key exclusion criteria (4 listed)
- history of smoking (> 5 pack years)
- history of diabetes
- diagnosis of cardiopulmonary disorder prior to inclusion
- medical treatment for arterial hypertension or hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Non-calcified Plaques
Time frame: 2 years
Incidence of non-calcified plaques (both mixed and soft plaques) assessed by Coronary CT in lifelong endurance athletes as compared to late-onset endurance athletes and non-athletic subjects.
2 secondary outcomes
Incidence of Atrial Fibrillation
Time frame: 4 years
Prevalence of Myocardial Fibrosis
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 41608826Pauwels R, Dausin C, Ruiz-Carmona S, De Bosscher R, De Paepe J, Bekhuis Y, Delpire B, Sinnaeve P, Dymarkowski S, Ghekiere O, Bruckers L, Kuznetsova T, Van De Heyning CM, Van Herck PL, Eijsvogels TMH, Herbots L, Robyns T, La Gerche A, Heidbuchel H, Willems R, Claessen G; Master@Heart Consortium. Wearable-Derived Training Load and Coronary Atherosclerosis in Middle-Aged and Older Athletes and Physically Active Controls: A New Perspective From the Master@Heart Study. Circulation. 2026 Apr 7;153(14):1009-1022. doi: 10.1161/CIRCULATIONAHA.125.077117. Epub 2026 Jan 29.
- Derived from this study: PubMed 39116385Janssens K, Foulkes SJ, Mitchell AM, Dausin C, Van Soest S, Spencer L, Rowe SJ, D'Ambrosio P, Elliott AD, Van Puyvelde T, Parr EB, Willems R, Heidbuchel H, Claessen G, La Gerche A. Blood pressure response to graded bicycle exercise in males and females across the age and fitness spectrum. Eur J Prev Cardiol. 2025 Jan 6;32(1):43-51. doi: 10.1093/eurjpc/zwae262.
- Derived from this study: PubMed 33927885De Bosscher R, Dausin C, Claus P, Bogaert J, Dymarkowski S, Goetschalckx K, Ghekiere O, Belmans A, Van De Heyning CM, Van Herck P, Paelinck B, El Addouli H, La Gerche A, Herbots L, Heidbuchel H, Willems R, Claessen G. Endurance exercise and the risk of cardiovascular pathology in men: a comparison between lifelong and late-onset endurance training and a non-athletic lifestyle - rationale and design of the Master@Heart study, a prospective cohort trial. BMJ Open Sport Exerc Med. 2021 Apr 16;7(2):e001048. doi: 10.1136/bmjsem-2021-001048. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Physical Activity, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
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 22 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guido Claessen, MD, PhD (+3216343397, guido.claessen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Non-calcified Plaques (time frame: 2 years). 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 NCT03711539, which also lists 3 linked publications.
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 3 Jul 2024.