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Recruiting NCT07363993

Interaction Between Intraventricular Flow and Cardiac Mechanics Using 3D Echocardiography in Athletes and Sedentary Subjects

Observational Athlete Heart

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Athlete Heart. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Exercise-induced cardiac remodeling, known as the "athlete's heart," corresponds to morphological and functional adaptations of the left ventricle in response to prolonged physical training. It is characterized in particular by physiological hypertrophy and improved myocardial function. Intraventricular blood flow interacts with cardiac mechanics. Regional shape (e.g., sphericity, wall curvature) and myocardial deformations guide flow patterns to create an optimal hemodynamic environment. The interaction between these different parameters in the athlete's heart remains insufficiently explored. In this context, 3D echocardiography makes it possible to combine indices derived from fluid dynamics, regional myocardial function, and cardiac geometry, enabling a comprehensive assessment of cardiac performance. Primary and secondary objectives: In this context, the aim of this project is to investigate the relationship between intraventricular flow and cardiac mechanics based on combined measurements of intraventricular flow (e.g., vorticity, pressure gradients), regional myocardial function (e.g., myocardial strain), and global/regional LV geometry (e.g., sphericity, wall curvature) in the athlete's heart. Since these parameters are interdependent, analyzing their interaction through the development of new echocardiographic tools based on 4D assessments will enable a comprehensive evaluation of functional improvements in the athlete's heart. The secondary objectives are to analyze the impact of dyssynchrony on intraventricular flow, to evaluate the influence of primary and secondary deformations on intraventricular flow, and to study cardiac function from an energetic perspective using non-invasive reconstruction of pressure-volume loops for cardiac work estimation. Methodology: The study will include 80 endurance athletes (ENT group) and 80 control subjects (CONT group). The main inclusion criteria common to both groups are: men and women aged 18-45 years, with no known heart disease and no cardiovascular risk factors (e.g., body mass index \> 30 kg/m², arterial hypertension). Athletes must train at least 10 hours per week for the past 5 years. Control subjects must not engage in more than 3 hours of physical activity per week. Athletes will be recruited from elite groups of various federations, during local long-distance races, or during clinical evaluations at Montpellier University Hospital (Dr. C. Hédon's department). Control subjects will be recruited in the Avignon area and in the cardiology department of Montpellier University Hospital during routine visits. Echocardiographic examinations will be performed in the left lateral decubitus position using Vivid systems with 4D probes. 4D and tri-plane acquisitions with color Doppler will allow assessment of cardiac structure and intraventricular flow. Data analysis will be performed using TOMTEC software, and scripts developed in Matlab and RStudio will process information related to shape, mechanical dispersion, and dyssynchrony. Intraventricular hemodynamics will be analyzed in collaboration with the CREATIS laboratory (D. Garcia), particularly through measurements of intraventricular pressure gradients and vorticity indices.

Primary outcome measures

  • Left ventricular principal strains [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
Secondary outcome measures (12)
  • Left ventricular secondary strains [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular principal and secondary strain rates [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global longitudinal strains [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global longitudinal strain rates [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global circumferential strains [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global circumferential strain rates [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global radial strains [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global radial strain rates [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global area strains [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Left ventricular global area strain rates [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Standard deviation of the time-to-peak of left ventricular segmental strains [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]
  • Maximum delay [Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.]

Eligibility criteria

Inclusion criteria for athletes:

\- Athlete practicing at least 10 hours of endurance training per week for a minimum of 5 years.

Inclusion criteria for controls:

\- Individual not training in more than 3 hours of physical activity per week.

Exclusion Criteria for both groups:

  • History of known heart disease;
  • Current cardiac rhythm disorder;
  • Individual with one or more cardiovascular risk factors (smoking, diabetes, hypertension, body mass index > 30 kg/m²);
  • Individual in a period of relative exclusion in relation to another protocol, or for whom the annual maximum compensation amount of €4,500 has been reached;
  • Individual not affiliated with a social security system, or not benefiting from such a system;
  • Pregnant or breastfeeding woman; patient unable to give informed consent; protected adults; vulnerable persons;
  • Individual deprived of liberty by judicial or administrative decision.

Exclusion criteria for athletes:

\- Use of substances listed on the prohibited substances list of the French Anti-Doping Agency

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • LaPEC — Avignon
  • CHU Montpellier — Montpellier

Identifiers

NCT: NCT07363993 · AU-112025-CM · LAPEC/2025/CARDIO-3D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗