NCT07363993

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Dec 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress25%
Dec 2025Aug 2027

Study Start

First participant enrolled

December 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

January 8, 2026

Last Update Submit

January 16, 2026

Conditions

Keywords

regional myocardial functionintraventricular flowcardiac geometryecho-3Dathlete's heart

Outcome Measures

Primary Outcomes (1)

  • Left ventricular principal strains

    The investigators will assess left ventricular principal strains in resting conditions using 3D echocardiography in the two groups.

    From date of enrollment until the date of evaluation, assessed up to 1 month.

Secondary Outcomes (74)

  • Left ventricular secondary strains

    From date of enrollment until the date of evaluation, assessed up to 1 month.

  • Left ventricular principal and secondary strain rates

    From date of enrollment until the date of evaluation, assessed up to 1 month.

  • Left ventricular global longitudinal strains

    From date of enrollment until the date of evaluation, assessed up to 1 month.

  • Left ventricular global longitudinal strain rates

    From date of enrollment until the date of evaluation, assessed up to 1 month.

  • Left ventricular global circumferential strains

    From date of enrollment until the date of evaluation, assessed up to 1 month.

  • +69 more secondary outcomes

Study Arms (2)

Controls

Sedentary controls

Athletes

Endurance athletes

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants in the ENT group will be recruited: * At Montpellier University Hospital, in the cardiology department of Dr Hédon, during a follow-up visit. * At various national training centers of the French Triathlon Federation and the French Athletics Federation; * During local long-distance events (e.g., long-distance triathlons, ultramarathons), with assessments carried out at the time of race bib collection. Healthy participants will be recruited in parallel In Avignon and the surrounding area. Some participants from the CONT or ENT groups will also be recruited in the cardiology department of Dr Hédon at Montpellier University Hospital during a follow-up visit, for example as part of systematic cardiovascular screening. These participants will have undergone a preventive cardiology consultation that revealed no abnormalities or pathology. If these participants meet all inclusion criteria, they may then be included in the study.

You may qualify if:

  • \- Athlete practicing at least 10 hours of endurance training per week for a minimum of 5 years.
  • \- Individual not training in more than 3 hours of physical activity per week.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LaPEC

Avignon, 84000, France

RECRUITING

CHU Montpellier

Montpellier, 34000, France

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 23, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations