Reverse Cardiac Remodeling Among Elite Athletes After Short and Long-term Detraining

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05555849
Collaborator
Rigshospitalet, Denmark (Other)
50
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78.9
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A prospective cohort study of reverse cardiac remodeling in recently retired elite athletes

    Aim To explore the remodeling of the heart focusing on right ventricle and left atria as well as pulmonary circulation in elite athletes at rest and during exercise as well as the effect of short and long-term reverse remodeling after the end of a professional sporting career

    Methods The investigators will initiate a 5-year longitudinal study of cardiac detraining in 50 former elite athletes.

    Primary outcome Change in left atrial minimum size after three months retirement (mL)

    Secondary outcome:
    • Change in left atrium (LA) function measured by strain and volume measures by echocardiography and magnetic resonance cor (MRc) after three months and the following years

    • Change in right and left ventricle size and function by echocardiography and magnetic resonance cor (MRc) after three months and the following years

    • Change in VO2max after three months and the following years

    • Change in diurnal ventricular and supraventricular ectopy and heart rate variability after three months and the following years

    • Change in blood pressure, BMI after three months and the following years

    • Change in plasma lipids and HbA1c after three months and the following years

    The full list of examinations includes:
    • Baseline family history, medical and training history

    • Cardio-pulmonary exercise test

    • 24-hour Holter monitoring

    • Biochemistry

    • Cardiac MR including contrast at rest and during exercise

    • Trans thoracic echocardiography

    Project organization and partners Recruitment of participants is organized in cooperation with the danish national elite sports organization (Team Danmark), Divisionsforeningen (The association of professional football clubs), and Spillerforeningen (The union of professional football players).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Reverse Cardiac Remodeling Among Elite Athletes After Short and Long-term Detraining
    Anticipated Study Start Date :
    Oct 1, 2022
    Anticipated Primary Completion Date :
    May 31, 2024
    Anticipated Study Completion Date :
    Apr 30, 2029

    Arms and Interventions

    Arm Intervention/Treatment
    Study group, Newly retired elite athletes

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

    Outcome Measures

    Primary Outcome Measures

    1. Left atrial minimum volume [5 years]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • ≥18 years at the time of screening

    • Former elite athlete from endurance sport discipline

    • End of elite sporting career >1 year ago

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bispebjerg-Frederiksberg Hospital Copenhagen Denmark 2000

    Sponsors and Collaborators

    • Bispebjerg Hospital
    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: Hanne K Rasmusen, ph.d., Bispebjerg Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanne Kruuse Rasmusen, Associate professor, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT05555849
    Other Study ID Numbers:
    • Studie 3
    First Posted:
    Sep 27, 2022
    Last Update Posted:
    Sep 27, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2022