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NCT Number: NCT03711539

Lifetime Endurance Exercise to Prevent Coronary Artery Disease

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.

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Key information

Age range

45 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital, Antwerpen, Edegem, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of Atrial Fibrillation

    Time frame: 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

  2. Prevalence of Myocardial Fibrosis

    Time frame: 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

Other outcomes

  1. Arterial Stiffness

    Time frame: 2 years

    To assess arterial stiffness by Applanation Tonometry in lifelong endurance athletes versus late-onset athletes and non-athletic individuals.

  2. Carotid Intima Thickness

    Time frame: 2 years

    To assess carotid intima thickness by Doppler Ultrasound in lifelong endurance athletes versus late-onset athletes and non-athletic individuals.

  3. Left Ventricular Diastolic Function

    Time frame: 2 years

    To assess left ventricular diastolic function by echocardiography in lifelong endurance athletes versus late-onset athletes and non-athletic individuals.

Study contacts

Contact information is provided by the study sponsor or research team.

Guido Claessen, MD, PhD

CONTACT

[email protected]

+3216343397

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Jessa Hospital
  • University Hospital, Antwerp

Registry information

Official study title

Lifetime Endurance Exercise to Prevent Coronary Artery Disease. A Comparison With Late-onset Endurance Training and a Sedentary Lifestyle

Acronym: MASTER@HEART

Important dates

Study start
2018
Primary completion
2021
Study completion
2025
First posted
Oct 18, 2018
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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