Recruiting
Risk of Sudden Cardiac Death in UN Athletes
NCT06518252
Arrhythmias, Cardiac, Athlete Heart
Bogotá, Cundinamarca, Colombia
View Trial Details
Recruiting
NCT Number: NCT07363993
Interaction Between Intraventricular Flow and Cardiac Mechanics Using 3D Echocardiography in Athletes and Sedentary Subjects
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.
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Conditions
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Observational
Primary location
LaPEC, Avignon, France
Loading trial locations.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Left ventricular principal strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular principal strains in resting conditions using 3D echocardiography in the two groups.
Secondary outcomes
-
Left ventricular secondary strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular secondary strains in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular principal and secondary strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular principal and secondary strain rates in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global longitudinal strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global longitudinal strains in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global longitudinal strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global longitudinal strain rates in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global circumferential strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global circumferential strains in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global circumferential strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global circumferential strain rates in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global radial strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global radial strains in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global radial strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global radial strain rates in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global area strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global area strains in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global area strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global area strain rates in resting conditions using 3D echocardiography in the two groups.
-
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.
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.
-
Maximum delay
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess maximum delay of left ventricular segmentary strains in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular longitudinal strain delay index
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular longitudinal strain delay index in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular post systolic strain index
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular post systolic strain index in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular myocardic work
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will left ventricular myocardic work in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular potential energy
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular potential energy in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular global longitudinal strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular global longitudinal strains in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular global longitudinal strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular global longitudinal strain rates in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular global circumferential strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular global circumferential strains in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular global circumferential strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular global circumferential strain rates in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular principal strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular principal strains in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular secondary strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular secondary strains in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular principal strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular principal strain rates in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular secondary strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular secondary strain rates in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular global area strain
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular global area strains in resting conditions using 3D echocardiography in the two groups.
-
Right ventricular global area strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular global area strain rates in resting conditions using 3D echocardiography in the two groups.
-
Left atrial global longitudinal strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left atrial global longitudinal strains in resting conditions using 3D echocardiography in the two groups.
-
Left atrial global longitudinal strain rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left atrial global longitudinal strain rates in resting conditions using 3D echocardiography in the two groups.
-
Right atrial global longitudinal strains
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right atrial global longitudinal strains in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular global longitudinal strains - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global longitudinal strains in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular global longitudinal strain rates - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global longitudinal strain rates in resting conditions using 2D echocardiography in the two groups.
-
Basal rotation - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular basal rotation in resting conditions using 2D echocardiography in the two groups.
-
Apical rotation - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular apical rotation in resting conditions using 2D echocardiography in the two groups.
-
Basal rotation - 3D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular basal rotation in resting conditions using 3D echocardiography in the two groups.
-
Apical rotation - 3D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular apical rotation in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular twist
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular twist in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular torsion
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular torsion in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular twisting/untwisting rates - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular twisting/untwisting rates in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular torsional rates - 3D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular torsional rates in resting conditions using 3D echocardiography in the two groups.
-
Left ventricular basal/apical rotational rates
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular basal/apical rotational rates in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular circumferential strains - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess regional left ventricular circumferential strains in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular circumferential strain rates - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular regional circumferential strain rates in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular global myocardial work - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular global myocardial work in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular myocardial constructive work - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular myocardial constructive work in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular myocardial wasted work - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular myocardial wasted work in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular myocardial work efficiency - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular myocardial work efficiency in resting conditions using 2D echocardiography in the two groups.
-
Right ventricular longitudinal strains - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular longitudinal strains in resting conditions using 2D echocardiography in the two groups.
-
Right ventricular longitudinal strain rates - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular longitudinal strain rates in resting conditions using 2D echocardiography in the two groups.
-
Left atrial longitudinal strain rates - 2D
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left atrial longitudinal strain rate components in resting conditions using 2D echocardiography in the two groups.
-
Intraventricular pressure gradient
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess intraventricular pressure gradient of the left ventricle in resting conditions using 2D echocardiography in the two groups.
-
Vorticity indexes
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular vorticity indexes in resting conditions using 2D echocardiography in the two groups.
-
Kinetic energy of left ventricular flow
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess kinetic energy of left ventricular flow in resting conditions using 2D echocardiography in the two groups.
-
Left ventricular wall thicknesses
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular wall thicknesses in resting conditions using echocardiography in the two groups.
-
Left ventricular diameters
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month..
The investigators will assess left ventricular diameters in resting conditions using echocardiography in the two groups.
-
Left ventricular volumes
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular volumes in resting conditions using echocardiography in the two groups.
-
Left ventricular mass
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular mass in resting conditions using echocardiography in the two groups.
-
Left ventricular ejection fraction
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular ejection fraction in resting conditions using echocardiography in the two groups.
-
Left ventricular Tissue Doppler Imaging
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular myocardial velocities in resting conditions using echocardiography in the two groups.
-
Left ventricular transmitral flow
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular transmitral flow in resting conditions using echocardiography in the two groups.
-
Left ventricular filling pressure index
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left ventricular filling pressure index in resting conditions using echocardiography in the two groups.
-
Right ventricular outflow tract diameter
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular outflow tract diameter in resting conditions using echocardiography in the two groups.
-
Tricuspid annular plane systolic excursion
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess tricuspid annular plane systolic excursion in resting conditions using echocardiography in the two groups.
-
Right ventricular fractional area change
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular fractional area change in resting conditions using echocardiography in the two groups.
-
Right ventricular ejection fraction
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month..
The investigators will assess right ventricular ejection fraction in resting conditions using echocardiography in the two groups.
-
Right ventricular Tissue Doppler Imaging
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular myocardial velocities in resting conditions using echocardiography in the two groups.
-
Right ventricular transtricuspid flow
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular transtricuspid flow in resting conditions using echocardiography in the two groups.
-
Right ventricular filling pressure gradient
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular filling pressure gradient in resting conditions using echocardiography in the two groups.
-
Right ventricular systolic pressure
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right ventricular systolic pressure in resting conditions using echocardiography in the two groups.
-
Left atrial volumes
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess left atrial volumes in resting conditions using echocardiography in the two groups.
-
Right atrial volumes
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess right atrial volumes in resting conditions using echocardiography in the two groups.
-
Blood pressures
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess blood pressures in resting conditions using a tensiometer in the two groups.
-
Heart rate
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess heart rate in resting conditions using echocardiography in the two groups.
-
Stroke volume
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess stroke volume in resting conditions using echocardiography in the two groups.
-
Cardiac output
Time frame: From date of enrollment until the date of evaluation, assessed up to 1 month.
The investigators will assess cardiac output in resting conditions using echocardiography in the two groups.
Sponsors and collaborators
Lead sponsor
University of Avignon
Other
Collaborators
- CHU Arnaud de Villeneuve MONTPELLIER
Registry information
Acronym: CARDIO-3D
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jan 23, 2026
- Registry last updated
- Jan 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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