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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1800
Est. completion date October 1, 2023
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 45 Years to 70 Years
Eligibility 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


Locations

Country Name City State
Belgium University Hospital, Antwerpen Edegem
Belgium Jessa Hospital Hasselt
Belgium UZLeuven Leuven

Sponsors (3)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven Jessa Hospital, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Arterial Stiffness To assess arterial stiffness by Applanation Tonometry in lifelong endurance athletes versus late-onset athletes and non-athletic individuals. 2 years
Other Carotid Intima Thickness To assess carotid intima thickness by Doppler Ultrasound in lifelong endurance athletes versus late-onset athletes and non-athletic individuals. 2 years
Other Left Ventricular Diastolic Function To assess left ventricular diastolic function by echocardiography in lifelong endurance athletes versus late-onset athletes and non-athletic individuals. 2 years
Primary Incidence of Non-calcified Plaques 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. 2 years
Secondary Incidence of Atrial Fibrillation To assess the association between the (a) amount and (b) starting age of lifelong endurance sports and atrial fibrillation assessed by Holter monitoring 4 years
Secondary Prevalence of Myocardial Fibrosis 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 2 years
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