Lifetime Endurance Exercise to Prevent Coronary Artery Disease

Recruiting

• Conditions: Physical Activity; Coronary Artery Disease; Lifestyle

• Registration Number: NCT03711539
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Study Start: 2018-10-18
• Study First Posted: 2018-10-18
• Primary Completion: 2021-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Non-calcified Plaques	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Atrial Fibrillation	4 years	To assess the association between the (a) amount and (b) starting age of lifelong endurance sports and atrial fibrillation assessed by Holter monitoring
Prevalence of Myocardial Fibrosis	2 years	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

Trial Locations

Locations (3)

UZLeuven; 🇧🇪 Leuven, Belgium

University Hospital, Antwerpen; 🇧🇪 Edegem, Belgium

Jessa Hospital; 🇧🇪 Hasselt, Belgium