Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03711539 |
| Other study ID # |
S61336 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 18, 2018 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
October 2020 |
| Source |
Universitaire Ziekenhuizen Leuven |
| Contact |
Guido Claessen, MD, PhD |
| Phone |
+3216343397 |
| Email |
guido.claessen[@]kuleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
