Lifetime Endurance Exercise to Prevent Coronary Artery Disease

NCT ID: NCT03711539

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2025-10-01

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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:

• 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

Exclusion Criteria

• history of smoking (> 5 pack years)
• history of diabetes
• diagnosis of cardiopulmonary disorder prior to inclusion
• medical treatment for arterial hypertension or hypercholesterolemia

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Antwerpen

Edegem, , Belgium

Site Status: RECRUITING

Jessa Hospital

Hasselt, , Belgium

Site Status: RECRUITING

UZLeuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Guido Claessen, MD, PhD

Role: CONTACT

guido.claessen@kuleuven.be

+3216343397

Facility Contacts

Hein Heidbuchel, MD, PhD

Role: primary

hein.heidbuchel@uantwerpen.be

+3238214693

Lieven Herbots, MD, PhD

Role: primary

lieven.herbots@jessazh.be

+3211373565

Guido Claessen, MD, PhD

Role: primary

guido.claessen@uzleuven.be

+3216343397

References

Janssens 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.

Reference Type: DERIVED

PMID: 39116385 (View on PubMed)

De 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.

Reference Type: DERIVED

PMID: 33927885 (View on PubMed)

Other Identifiers

S61336

Identifier Type: -

Identifier Source: org_study_id