ClinicalTrials.gg
RecruitingNCT07363993CARDIO-3DUpdated Jan 23, 2026

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

An observational study in Athlete Heart, sponsored by University of Avignon. Recruiting at 2 sites in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by University of Avignon · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
160
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Athlete Heart

Keywords

  • regional myocardial function
  • intraventricular flow
  • cardiac geometry
  • echo-3D
  • athlete's heart
03

In context

Lead sponsor

University of Avignon is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

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, > 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 ; 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • Controls

    Sedentary controls

  • Athletes

    Endurance athletes

06

What researchers measure

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.

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

Secondary outcomes

  1. Left ventricular secondary strains

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

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

  2. Left ventricular principal and secondary strain rates

    The investigators will assess left ventricular principal and secondary strain rates in resting conditions using 3D echocardiography in the two groups.

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

  3. Left ventricular global longitudinal strains

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

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

  4. Left ventricular global longitudinal strain rates

    The investigators will assess left ventricular global longitudinal strain rates in resting conditions using 3D echocardiography in the two groups.

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

  5. Left ventricular global circumferential strains

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

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

  6. Left ventricular global circumferential strain rates

    The investigators will assess left ventricular global circumferential strain rates in resting conditions using 3D echocardiography in the two groups.

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

  7. Left ventricular global radial strains

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

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

  8. Left ventricular global radial strain rates

    The investigators will assess left ventricular global radial strain rates in resting conditions using 3D echocardiography in the two groups.

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

  9. Left ventricular global area strains

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

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

  10. Left ventricular global area strain rates

    The investigators will assess left ventricular global area strain rates in resting conditions using 3D echocardiography in the two groups.

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

  11. Standard deviation of the time-to-peak of left ventricular segmental strains

    The investigators will assess standard deviation of the time-to-peak of left ventricular segmental strains in resting conditions using 3D echocardiography in the two groups.

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

  12. Maximum delay

    The investigators will assess maximum delay of left ventricular segmentary strains in resting conditions using 3D echocardiography in the two groups.

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

  13. Left ventricular longitudinal strain delay index

    The investigators will assess left ventricular longitudinal strain delay index in resting conditions using 3D echocardiography in the two groups.

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

  14. Left ventricular post systolic strain index

    The investigators will assess left ventricular post systolic strain index in resting conditions using 3D echocardiography in the two groups.

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

  15. Left ventricular myocardic work

    The investigators will left ventricular myocardic work in resting conditions using 3D echocardiography in the two groups.

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

  16. Left ventricular potential energy

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

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

  17. Right ventricular global longitudinal strains

    The investigators will assess right ventricular global longitudinal strains in resting conditions using 3D echocardiography in the two groups.

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

  18. Right ventricular global longitudinal strain rates

    The investigators will assess right ventricular global longitudinal strain rates in resting conditions using 3D echocardiography in the two groups.

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

  19. Right ventricular global circumferential strains

    The investigators will assess right ventricular global circumferential strains in resting conditions using 3D echocardiography in the two groups.

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

  20. Right ventricular global circumferential strain rates

    The investigators will assess right ventricular global circumferential strain rates in resting conditions using 3D echocardiography in the two groups.

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

  21. Right ventricular principal strains

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

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

  22. Right ventricular secondary strains

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

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

  23. Right ventricular principal strain rates

    The investigators will assess right ventricular principal strain rates in resting conditions using 3D echocardiography in the two groups.

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

  24. Right ventricular secondary strain rates

    The investigators will assess right ventricular secondary strain rates in resting conditions using 3D echocardiography in the two groups.

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

  25. Right ventricular global area strain

    The investigators will assess right ventricular global area strains in resting conditions using 3D echocardiography in the two groups.

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

  26. Right ventricular global area strain rates

    The investigators will assess right ventricular global area strain rates in resting conditions using 3D echocardiography in the two groups.

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

  27. Left atrial global longitudinal strains

    The investigators will assess left atrial global longitudinal strains in resting conditions using 3D echocardiography in the two groups.

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

  28. Left atrial global longitudinal strain rates

    The investigators will assess left atrial global longitudinal strain rates in resting conditions using 3D echocardiography in the two groups.

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

  29. Right atrial global longitudinal strains

    The investigators will assess right atrial global longitudinal strains in resting conditions using 3D echocardiography in the two groups.

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

  30. Left ventricular global longitudinal strains - 2D

    The investigators will assess left ventricular global longitudinal strains in resting conditions using 2D echocardiography in the two groups.

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

  31. Left ventricular global longitudinal strain rates - 2D

    The investigators will assess left ventricular global longitudinal strain rates in resting conditions using 2D echocardiography in the two groups.

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

  32. Basal rotation - 2D

    The investigators will assess left ventricular basal rotation in resting conditions using 2D echocardiography in the two groups.

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

  33. Apical rotation - 2D

    The investigators will assess left ventricular apical rotation in resting conditions using 2D echocardiography in the two groups.

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

  34. Basal rotation - 3D

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

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

  35. Apical rotation - 3D

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

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

  36. Left ventricular twist

    The investigators will assess left ventricular twist in resting conditions using 2D echocardiography in the two groups.

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

  37. Left ventricular torsion

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

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

  38. Left ventricular twisting/untwisting rates - 2D

    The investigators will assess left ventricular twisting/untwisting rates in resting conditions using 2D echocardiography in the two groups.

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

  39. Left ventricular torsional rates - 3D

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

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

  40. Left ventricular basal/apical rotational rates

    The investigators will assess left ventricular basal/apical rotational rates in resting conditions using 2D echocardiography in the two groups.

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

  41. Left ventricular circumferential strains - 2D

    The investigators will assess regional left ventricular circumferential strains in resting conditions using 2D echocardiography in the two groups.

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

  42. Left ventricular circumferential strain rates - 2D

    The investigators will assess left ventricular regional circumferential strain rates in resting conditions using 2D echocardiography in the two groups.

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

  43. Left ventricular global myocardial work - 2D

    The investigators will assess left ventricular global myocardial work in resting conditions using 2D echocardiography in the two groups.

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

  44. Left ventricular myocardial constructive work - 2D

    The investigators will assess left ventricular myocardial constructive work in resting conditions using 2D echocardiography in the two groups.

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

  45. Left ventricular myocardial wasted work - 2D

    The investigators will assess left ventricular myocardial wasted work in resting conditions using 2D echocardiography in the two groups.

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

  46. Left ventricular myocardial work efficiency - 2D

    The investigators will assess left ventricular myocardial work efficiency in resting conditions using 2D echocardiography in the two groups.

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

  47. Right ventricular longitudinal strains - 2D

    The investigators will assess right ventricular longitudinal strains in resting conditions using 2D echocardiography in the two groups.

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

  48. Right ventricular longitudinal strain rates - 2D

    The investigators will assess right ventricular longitudinal strain rates in resting conditions using 2D echocardiography in the two groups.

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

  49. Left atrial longitudinal strain rates - 2D

    The investigators will assess left atrial longitudinal strain rate components in resting conditions using 2D echocardiography in the two groups.

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

  50. Intraventricular pressure gradient

    The investigators will assess intraventricular pressure gradient of the left ventricle in resting conditions using 2D echocardiography in the two groups.

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

  51. Vorticity indexes

    The investigators will assess left ventricular vorticity indexes in resting conditions using 2D echocardiography in the two groups.

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

  52. Kinetic energy of left ventricular flow

    The investigators will assess kinetic energy of left ventricular flow in resting conditions using 2D echocardiography in the two groups.

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

  53. Left ventricular wall thicknesses

    The investigators will assess left ventricular wall thicknesses in resting conditions using echocardiography in the two groups.

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

  54. Left ventricular diameters

    The investigators will assess left ventricular diameters in resting conditions using echocardiography in the two groups.

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

  55. Left ventricular volumes

    The investigators will assess left ventricular volumes in resting conditions using echocardiography in the two groups.

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

  56. Left ventricular mass

    The investigators will assess left ventricular mass in resting conditions using echocardiography in the two groups.

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

  57. Left ventricular ejection fraction

    The investigators will assess left ventricular ejection fraction in resting conditions using echocardiography in the two groups.

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

  58. Left ventricular Tissue Doppler Imaging

    The investigators will assess left ventricular myocardial velocities in resting conditions using echocardiography in the two groups.

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

  59. Left ventricular transmitral flow

    The investigators will assess left ventricular transmitral flow in resting conditions using echocardiography in the two groups.

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

  60. Left ventricular filling pressure index

    The investigators will assess left ventricular filling pressure index in resting conditions using echocardiography in the two groups.

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

  61. Right ventricular outflow tract diameter

    The investigators will assess right ventricular outflow tract diameter in resting conditions using echocardiography in the two groups.

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

  62. Tricuspid annular plane systolic excursion

    The investigators will assess tricuspid annular plane systolic excursion in resting conditions using echocardiography in the two groups.

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

  63. Right ventricular fractional area change

    The investigators will assess right ventricular fractional area change in resting conditions using echocardiography in the two groups.

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

  64. Right ventricular ejection fraction

    The investigators will assess right ventricular ejection fraction in resting conditions using echocardiography in the two groups.

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

  65. Right ventricular Tissue Doppler Imaging

    The investigators will assess right ventricular myocardial velocities in resting conditions using echocardiography in the two groups.

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

  66. Right ventricular transtricuspid flow

    The investigators will assess right ventricular transtricuspid flow in resting conditions using echocardiography in the two groups.

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

  67. Right ventricular filling pressure gradient

    The investigators will assess right ventricular filling pressure gradient in resting conditions using echocardiography in the two groups.

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

  68. Right ventricular systolic pressure

    The investigators will assess right ventricular systolic pressure in resting conditions using echocardiography in the two groups.

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

  69. Left atrial volumes

    The investigators will assess left atrial volumes in resting conditions using echocardiography in the two groups.

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

  70. Right atrial volumes

    The investigators will assess right atrial volumes in resting conditions using echocardiography in the two groups.

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

  71. Blood pressures

    The investigators will assess blood pressures in resting conditions using a tensiometer in the two groups.

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

  72. Heart rate

    The investigators will assess heart rate in resting conditions using echocardiography in the two groups.

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

  73. Stroke volume

    The investigators will assess stroke volume in resting conditions using echocardiography in the two groups.

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

  74. Cardiac output

    The investigators will assess cardiac output in resting conditions using echocardiography in the two groups.

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

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Aug 2027, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2026
First posted
Jan 23, 2026
StartActual
Dec 1, 2025
Primary completionEst.
Aug 31, 2027
CompletionEst.
Aug 31, 2027
Last update
Jan 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07363993
Lead sponsor
University of Avignon
Collaborators
CHU Arnaud de Villeneuve MONTPELLIER
Responsible party
Sponsor
First posted
Jan 23, 2026
Start date
Dec 1, 2025
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Jan 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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