Clinical trial NCT05543525: Myocardial Mechanics in Athlete's Heart
Official title: Advanced Myocardial Deformation Echocardiography for the Athlete's Heart Evaluation: Functional and Mechanistic Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athlete Heart
Keywords: speckle tracking echocardiography
myocardial deformation
functional capacity
layer-specific strain
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: INSERM, CIC 1433
First posted: 2022-09-16
Enrollment: 191
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cross-sectional study, using data from young high-performance athletes referred to the cardiologic department of Nancy University Hospital for a pre-participation medical evaluation.

Brief summary: 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.

Detailed description: 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Multilayer (= epi- and endocardial) left ventricular global longitudinal strain using Speckle-tracking echocardiography
timeFrame: Baseline
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Height
timeFrame: baseline
measure: Weight
timeFrame: baseline
measure: BMI
timeFrame: baseline
measure: Heart rate
timeFrame: baseline
measure: Type of practiced sport
timeFrame: baseline
measure: Inter ventricular septum diameter
timeFrame: baseline
measure: Left ventricle indexed mass
timeFrame: baseline
measure: Left ventricular Ejection Fraction
timeFrame: baseline
measure: left ventricular End-diastolic volume
timeFrame: baseline
measure: Cardiac Index
timeFrame: baseline
measure: Maximal E-wave velocity and Maximal A-wave velocity
timeFrame: baseline
measure: Left atrium End-systolic volume
timeFrame: baseline
measure: left ventricular global longitudinal strain (peak G) assessed by Speckle-tracking echocardiography
timeFrame: baseline
measure: PSI (pre stretch index) assessed by Speckle-tracking echocardiography
timeFrame: baseline
measure: PST (postsystolic thickening) assessed by Speckle-tracking echocardiography
timeFrame: baseline
measure: Peak VO2
timeFrame: baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chru Nancy
Study officials:
affiliation: CHRU Nancy
name: Nathalie Pace, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spirito P, Pelliccia A, Proschan MA, Granata M, Spataro A, Bellone P, Caselli G, Biffi A, Vecchio C, Maron BJ. Morphology of the "athlete's heart" assessed by echocardiography in 947 elite athletes representing 27 sports. Am J Cardiol. 1994 Oct 15;74(8):802-6. doi: 10.1016/0002-9149(94)90439-1.
citation: Caselli S, Maron MS, Urbano-Moral JA, Pandian NG, Maron BJ, Pelliccia A. Differentiating left ventricular hypertrophy in athletes from that in patients with hypertrophic cardiomyopathy. Am J Cardiol. 2014 Nov 1;114(9):1383-9. doi: 10.1016/j.amjcard.2014.07.070. Epub 2014 Aug 12.
citation: Schnell F, Matelot D, Daudin M, Kervio G, Mabo P, Carre F, Donal E. Mechanical Dispersion by Strain Echocardiography: A Novel Tool to Diagnose Hypertrophic Cardiomyopathy in Athletes. J Am Soc Echocardiogr. 2017 Mar;30(3):251-261. doi: 10.1016/j.echo.2016.11.013. Epub 2017 Jan 5.
citation: Abuli M, de la Garza MS, Sitges M. Differentiating Athlete's Heart from Left Ventricle Cardiomyopathies. J Cardiovasc Transl Res. 2020 Jun;13(3):265-273. doi: 10.1007/s12265-020-10021-8. Epub 2020 May 14.
citation: Santoro A, Alvino F, Antonelli G, Caputo M, Padeletti M, Lisi M, Mondillo S. Endurance and Strength Athlete's Heart: Analysis of Myocardial Deformation by Speckle Tracking Echocardiography. J Cardiovasc Ultrasound. 2014 Dec;22(4):196-204. doi: 10.4250/jcu.2014.22.4.196. Epub 2014 Dec 26.
citation: D'Ascenzi F, Solari M, Mazzolai M, Cameli M, Lisi M, Andrei V, Focardi M, Bonifazi M, Mondillo S. Two-dimensional and three-dimensional left ventricular deformation analysis: a study in competitive athletes. Int J Cardiovasc Imaging. 2016 Dec;32(12):1697-1705. doi: 10.1007/s10554-016-0961-6. Epub 2016 Aug 13.
citation: Huttin O, Girerd N, Coiro S, Bozec E, Selton-Suty C, Lamiral Z, Frikha Z, Kobayashi M, Argulian E, Narula J, Fraser AG, Rossignol P, Zannad F. Association Between Layer-Specific Longitudinal Strain and Risk Factors of Heart Failure and Dyspnea: A Population-Based Study. J Am Soc Echocardiogr. 2019 Jul;32(7):854-865.e8. doi: 10.1016/j.echo.2019.03.011. Epub 2019 May 16.