NCT05543525

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
191

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 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

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

September 8, 2022

Last Update Submit

August 29, 2023

Conditions

Keywords

speckle tracking echocardiographymyocardial deformationfunctional capacitylayer-specific strain

Outcome Measures

Primary Outcomes (1)

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

    expressed in %

    Baseline

Secondary Outcomes (17)

  • Age

    Baseline

  • Height

    baseline

  • Weight

    baseline

  • BMI

    baseline

  • Heart rate

    baseline

  • +12 more secondary outcomes

Study Arms (2)

Male Athletes

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

Other: EchocardiographyOther: Cardiopulmonary exercise testing

Control Group

A subgroup of 161 participants in a population-based cohort (STANISLAS Cohort) restricted by age and sex to create a control group in the current analysis.

Other: EchocardiographyOther: Cardiopulmonary exercise testing

Interventions

Transthoracic echocardiography

Control GroupMale Athletes

Cardiopulmonary exercise testing

Control GroupMale Athletes

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Nancy

Nancy, 54000, France

Location

Related Publications (7)

  • 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.

    PMID: 7942554BACKGROUND
  • 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.

    PMID: 25217454BACKGROUND
  • 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.

    PMID: 28065584BACKGROUND
  • 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.

    PMID: 32410209BACKGROUND
  • 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.

    PMID: 25580194BACKGROUND
  • 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.

    PMID: 27522672BACKGROUND
  • 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.

    PMID: 31104890BACKGROUND

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Nathalie Pace, MD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine (MD) in Cardiology

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 16, 2022

Study Start

July 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately following publication. No end date.
Access Criteria
Researchers who provide a methodologically sound proposal.To achieve aims in the approved proposal. Proposals should be directed to n.pace@chru-nancy.fr.

Locations