Lifetime Endurance Exercise to Prevent Coronary Artery Disease

NCT03711539 | Recruiting

• 1 other identifier: S61336
• Study Type: observational
• Target: 1,800
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease; Physical Activity; Lifestyle

Keywords

Endurance Exercise; Coronary Artery Disease; Atrial Fibrillation; Myocardial Fibrosis; Coronary CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Atrial Fibrillation

  4 years

• Prevalence of Myocardial Fibrosis

  2 years

Other Outcomes (3)

• Arterial Stiffness

  2 years

• Carotid Intima Thickness

  2 years

• Left Ventricular Diastolic Function

  2 years

Study Arms (3)

Lifelong Endurance Athletes

i) 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. ii) Aged 45-70 years. iii) Involved in competition and high-level training: more than 10 hours per week for cyclists and triathletes or more than 6 hours per week for runners and rowers. Subjects will be excluded if: i) they have a history of smoking (\> 5 pack years) or diabetes, ii) had been diagnosed with a cardiopulmonary disorder prior to inclusion.

Late-onset Endurance Athletes

i) 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. ii) Aged 45-70 years. iii) Involved in competition and high-level training: more than 10 hours per week for cyclists and triathletes or more than 6 hours per week for runners and rowers. Subjects will be excluded if: i) they have a history of smoking (\> 5 pack years) or diabetes, ii) they have a history of smoking (\> 5 pack years) or diabetes, ii) had been diagnosed with a cardiopulmonary disorder prior to inclusion.

Healthy Non-athletes

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. Subjects will be excluded if they: i) had been involved in regular sports practice more than \>3 hours / week, ii) have a history of smoking (\> 5 pack years) or diabetes, or iii) had been diagnosed with a cardiopulmonary disorder prior to inclusion. Participation in regular sports with a low dynamic component (e.g. billiards, darts or bowling) \>3 hours /week is allowed.

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• history of smoking (\> 5 pack years)
• history of diabetes
• medical treatment for arterial hypertension or hypercholesterolemia

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• University Hospital, Antwerp: collaborator
• Jessa Hospital: collaborator

Study Sites (3)

University Hospital, Antwerpen

Edegem, 2650, Belgium

RECRUITING

Jessa Hospital

Hasselt, 3500, Belgium

RECRUITING

UZLeuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (2)

• Janssens K, Foulkes SJ, Mitchell AM, Dausin C, Van Soest S, Spencer L, Rowe SJ, D'Ambrosio P, Elliott AD, Van Puyvelde T, Parr EB, Willems R, Heidbuchel H, Claessen G, La Gerche A. Blood pressure response to graded bicycle exercise in males and females across the age and fitness spectrum. Eur J Prev Cardiol. 2025 Jan 6;32(1):43-51. doi: 10.1093/eurjpc/zwae262.

  PMID: 39116385 DERIVED

• 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.

  PMID: 33927885 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Motor Activity; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guido Claessen, MD, PhD

CONTACT

+3216343397; guido.claessen@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 18, 2018
• Study Start: October 18, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (3)