Clinical trial NCT03711539: Lifetime Endurance Exercise to Prevent Coronary Artery Disease
Official title: Lifetime Endurance Exercise to Prevent Coronary Artery Disease. A Comparison With Late-onset Endurance Training and a Sedentary Lifestyle
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Physical Activity
Lifestyle
Keywords: Endurance Exercise
Coronary Artery Disease
Atrial Fibrillation
Myocardial Fibrosis
Coronary CT
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Jessa Hospital
First posted: 2018-10-18
Enrollment: 1800
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Incidence of Non-calcified Plaques
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of Atrial Fibrillation
timeFrame: 4 years
measure: Prevalence of Myocardial Fibrosis
timeFrame: 2 years
Other outcomes:
measure: Arterial Stiffness
timeFrame: 2 years
measure: Carotid Intima Thickness
timeFrame: 2 years
measure: Left Ventricular Diastolic Function
timeFrame: 2 years
Locations:
city: Edegem
country: Belgium
facility: University Hospital, Antwerpen
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
References:
citation: 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.