NCT05555849

Brief Summary

Exercise has many well-documented effects in the prevention or treatment of disease, but recently some studies have raised awareness of the possible negative effects of too much exercise. In former elite endurance athletes, an increased risk of cardiac fibrosis and arrhythmias have been described. Whether exercise itself is the culprit remains to be explored. The right cardiac ventricle can be overloaded during long-term intense exercise, due to increased volume load and possibly an increased afterload. In a subgroub of athletes the appearance with morphological and functional changes resembling an ARVC like phenotype. Furthermore, atrial fibrillation among male middle-aged athletes is up to 5 times more common compared to age-matched non-athletes. The working hypothesis of this study is that male athletes remodel more than females and that some of thise changes are already measureable early after end of elite sporting carreer. In this prospective cohort study, of 50 elite athletes at retirement, after 3 months and thereafter yearly for five years, to determine the characteristics of remodeling of the heart focusing on the left atrial and right ventricle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

July 19, 2022

Last Update Submit

September 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Left atrial minimum volume

    Primary endpoint The primary aim is to assess the long-term effect on remodeling of left atrium size measured by 2D echocardiography • Primary endpoint: Change in LA minimum volume (mL)

    5 years

Study Arms (1)

Study group, Newly retired elite athletes

Elite athletes at the time of retirement of professional career. Reinvestigated after three months and thereafter yearly.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy danish elite athletes over the age of 18, who recently retired from elitesports.

You may qualify if:

  • ≥18 years at the time of screening
  • Former elite athlete from endurance sport discipline
  • End of elite sporting career \>1 year ago

You may not qualify if:

  • Any known cardiac disease
  • Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could impose the subject at significant risk, or interfere significantly with the subject's participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg-Frederiksberg Hospital

Copenhagen, Copenhagen, 2000, Denmark

Location

Related Publications (1)

  • Aaroee M, Tischer SG, Christensen R, Sajadieh A, Dall CH, Thune JJ, Rasmusen H. Long-term left atrial adaptations to reduced training load in former elite athletes: a long-term follow-up longitudinal observational study. BMJ Open Sport Exerc Med. 2025 Apr 3;11(2):e002379. doi: 10.1136/bmjsem-2024-002379. eCollection 2025.

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hanne K Rasmusen, ph.d.

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

September 27, 2022

Study Start

May 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

September 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Registration After the provision of informed consent, each subject will be registered in a logged web-based register (REDCap). A list of registered participants will be kept linking the subject identification number. This list will be entered in a separate database and data will be encrypted. Information will not be passed on to a third party. Bispebjerg-Frederiksberg department of cardiology supervised by consultant doctor Hanne Kruuse Rasmusen will have the overall ownership and intellectual property rights to data collected in during this project.

Locations