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Athlete HeartNCT05543525

Myocardial Mechanics in Athlete's Heart

An observational study of Athlete Heart, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Echocardiographic assessment of the endurance athletes' heart remains challenging due to a phenotypic overlap between reactive physiological adaptation and pathological remodelling. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Athlete Heart
What is being tested?
Echocardiography and Cardiopulmonary exercise testing
How many people
191 participants
Where
1 siteFrance
Study dates
1 Jul 2021to 1 Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chru Nancy

    Nancy, 54000

Other trials in France

About this study

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

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.

Read the 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%.

Conditions
Athlete Heart
Being tested
Echocardiography, Cardiopulmonary exercise testing
Keywords
speckle tracking echocardiography, myocardial deformation, functional capacity, layer-specific strain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyOther

    Transthoracic echocardiography

  • Cardiopulmonary exercise testingOther

    Cardiopulmonary exercise testing

Study groups in NCT05543525
Study groupRoleWhat they receive
Male AthletesAthletes who underwent a pre-participation medical evaluation in the Nancy University Hospital between January 1st, 2013, and January 1st, 2020.
Receives: Other: Echocardiography; Other: Cardiopulmonary exercise testing
Control GroupA 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.
Receives: Other: Echocardiography; Other: Cardiopulmonary exercise testing

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    expressed in %

    Measured: Baseline

Secondary outcomes (17)

  1. Age

    years

    Measured: Baseline

  2. Height

    meter

    Measured: baseline

  3. Weight

    meter

    Measured: baseline

  4. BMI

    kg/m²

    Measured: baseline

  5. Heart rate

    bpm

    Measured: baseline

  6. Type of practiced sport

    soccer, basketball, handball

    Measured: baseline

  7. Inter ventricular septum diameter

    mm

    Measured: baseline

  8. Left ventricle indexed mass

    g/m²

    Measured: baseline

  9. Left ventricular Ejection Fraction

    using simpson's biplane method, expressed in %

    Measured: baseline

  10. left ventricular End-diastolic volume

    ml

    Measured: baseline

  11. Cardiac Index

    ml/min/m²

    Measured: baseline

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

    m/s

    Measured: baseline

  13. Left atrium End-systolic volume

    ml/m²

    Measured: baseline

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

    expressed in %

    Measured: baseline

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

    expressed in %

    Measured: baseline

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

    expressed in %

    Measured: baseline

  17. Peak VO2

    L/min

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start1 Jul 2021
  3. Primary completion1 Jan 2022
  4. Study completion1 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
191 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05543525
Sponsor's protocol ID
2022PI064
Status last verified
Aug 2023
First submitted
8 Sep 2022
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • 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.

    PubMed 7942554

  • 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.

    PubMed 25217454

  • 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.

    PubMed 28065584

  • 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.

    PubMed 32410209

  • 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.

    PubMed 25580194

  • 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.

    PubMed 27522672

  • 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.

    PubMed 31104890

Questions about this trial

What is this clinical trial studying?

An observational study of Athlete Heart, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multilayer (= epi- and endocardial) left ventricular global longitudinal strain using Speckle-tracking echocardiography (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05543525, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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