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Completed

NCT Number: NCT05543525

Myocardial Mechanics in Athlete's Heart

Echocardiographic assessment of the endurance athletes' heart remains challenging due to a phenotypic overlap between reactive physiological adaptation and pathological remodelling. The lower range of normal values of lLeft ventricle systolic ejection fraction (LVEF) and global longitudinal strain (GLS) in athletes makes it difficult to differentiate changes related to adaptive remodelling or indicative of early cardiomyopathy.

This study aims to improve the assessment of athletes' hearts by identifying echocardiographic phenotypes, using a speckle tracking including temporal deformation pattern and layer-specific approach, and to define predictive factors of subtle LV systolic dysfunction and of mechanical LV abnormalities.

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Key information

Conditions

Athlete Heart

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Chru Nancy

Nancy, 54000, France

About this study

Healthy male athletes belonging to local clubs, who underwent a pre-participation medical evaluation at the University Hospital of Nancy between 2013 and 2020, will be screened. Clinical, echocardiographic and cardiopulmonary exercise testing data will be compared to a group of healthy men from the STANISLAS cohort. Subtle LV dysfunction will be defined by a GLS <17.5%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • athletes who underwent a pre-participation medical evaluation in the Nancy University Hospital between January 1st, 2013, and January 1st, 2020

Exclusion criteria

  • female athletes,
  • athletes followed for cardiomyopathy
  • athletes who did not have transthoracic echocardiography (TTE) performed.

Treatment and study plan

echocardiography

Other

Transthoracic echocardiography

cardiopulmonary exercise testing

Other

Cardiopulmonary exercise testing

Primary outcomes

  1. Multilayer (= epi- and endocardial) left ventricular global longitudinal strain using Speckle-tracking echocardiography

    Time frame: Baseline

    expressed in %

Secondary outcomes

  1. Age

    Time frame: Baseline

    years

  2. Height

    Time frame: baseline

    meter

  3. Weight

    Time frame: baseline

    meter

  4. BMI

    Time frame: baseline

    kg/m²

  5. Heart rate

    Time frame: baseline

    bpm

  6. Type of practiced sport

    Time frame: baseline

    soccer, basketball, handball

  7. Inter ventricular septum diameter

    Time frame: baseline

    mm

  8. Left ventricle indexed mass

    Time frame: baseline

    g/m²

  9. Left ventricular Ejection Fraction

    Time frame: baseline

    using simpson's biplane method, expressed in %

  10. left ventricular End-diastolic volume

    Time frame: baseline

    ml

  11. Cardiac Index

    Time frame: baseline

    ml/min/m²

  12. Maximal E-wave velocity and Maximal A-wave velocity

    Time frame: baseline

    m/s

  13. Left atrium End-systolic volume

    Time frame: baseline

    ml/m²

  14. left ventricular global longitudinal strain (peak G) assessed by Speckle-tracking echocardiography

    Time frame: baseline

    expressed in %

  15. PSI (pre stretch index) assessed by Speckle-tracking echocardiography

    Time frame: baseline

    expressed in %

  16. PST (postsystolic thickening) assessed by Speckle-tracking echocardiography

    Time frame: baseline

    expressed in %

  17. Peak VO2

    Time frame: baseline

    L/min

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • INSERM, CIC 1433
  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Advanced Myocardial Deformation Echocardiography for the Athlete's Heart Evaluation: Functional and Mechanistic Analysis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2022
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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