NCT07363993 Interaction Between Intraventricular Flow and Cardiac Mechanics Using 3D Echocardiography in Athletes and Sedentary Subjects
| NCT ID | NCT07363993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Avignon |
| Condition | Athlete Heart |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2025-12-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT07363993 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Athlete Heart. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07363993 currently recruiting?
Yes, NCT07363993 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Avignon to inquire about joining.
Where is the NCT07363993 trial being conducted?
This trial is being conducted at Avignon, France, Montpellier, France.
Who is sponsoring the NCT07363993 clinical trial?
NCT07363993 is sponsored by University of Avignon. The trial plans to enroll 160 participants.