跳至主要内容
临床试验/NCT07363993
NCT07363993招募中不适用

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

University of Avignon2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
2
主要终点
Left ventricular principal strains

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Athletes

Endurance athletes

Controls

Sedentary controls

结局指标

主要结局

Left ventricular principal strains

时间窗: 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.

次要结局

  • 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.)
  • Left ventricular global circumferential strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular global radial strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular global radial strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular global area strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular global area strain rates(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(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Maximum delay(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular longitudinal strain delay index(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular post systolic strain index(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular myocardic work(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular potential energy(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular global longitudinal strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular global longitudinal strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular global circumferential strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular global circumferential strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular principal strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular secondary strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular principal strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular secondary strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular global area strain(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular global area strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left atrial global longitudinal strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left atrial global longitudinal strain rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right atrial global longitudinal strains(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular global longitudinal strains - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular global longitudinal strain rates - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Basal rotation - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Apical rotation - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Basal rotation - 3D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Apical rotation - 3D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular twist(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular torsion(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular twisting/untwisting rates - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular torsional rates - 3D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular basal/apical rotational rates(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular circumferential strains - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular circumferential strain rates - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular global myocardial work - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular myocardial constructive work - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular myocardial wasted work - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular myocardial work efficiency - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular longitudinal strains - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular longitudinal strain rates - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left atrial longitudinal strain rates - 2D(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Intraventricular pressure gradient(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Vorticity indexes(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Kinetic energy of left ventricular flow(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular wall thicknesses(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular diameters(From date of enrollment until the date of evaluation, assessed up to 1 month..)
  • Left ventricular volumes(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular mass(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular ejection fraction(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular Tissue Doppler Imaging(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular transmitral flow(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left ventricular filling pressure index(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular outflow tract diameter(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Tricuspid annular plane systolic excursion(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular fractional area change(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular ejection fraction(From date of enrollment until the date of evaluation, assessed up to 1 month..)
  • Right ventricular Tissue Doppler Imaging(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular transtricuspid flow(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular filling pressure gradient(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right ventricular systolic pressure(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Left atrial volumes(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Right atrial volumes(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Blood pressures(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Heart rate(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Stroke volume(From date of enrollment until the date of evaluation, assessed up to 1 month.)
  • Cardiac output(From date of enrollment until the date of evaluation, assessed up to 1 month.)

研究者

发起方
University of Avignon
申办方类型
Other
责任方
Sponsor

研究点 (2)

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