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临床试验/NCT07753694
NCT07753694尚未招募不适用

Echocardiographic Assessment of the Acute Impact of an Ultra-Trail Race on Cardiac Function

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2027年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Left Ventricular Global Longitudinal Strain (GLS)

研究概览

简要总结

This prospective observational study aims to investigate the acute cardiovascular effects of ultra-endurance running using comprehensive echocardiographic assessment combined with biological analyses. The main hypothesis is that participation in an ultra-trail race induces acute and transient changes in cardiac function involving both the left and right ventricles, associated with elevations in cardiac biomarkers, with physiological responses varying according to race distance and training level and showing spontaneous recovery within the days following the event.

Adult amateur runners participating in ultra-trail races of 80 km or 160 km will undergo standardized clinical evaluation, electrocardiography, and transthoracic echocardiography with myocardial deformation analysis at multiple time points, including baseline, pre-effort, during the race, immediately after exercise, and during early recovery approximately one week after the event. Biological sampling will be performed before the race, immediately after exercise, and at follow-up.

The primary objective is to evaluate acute changes in left ventricular systolic function assessed by global longitudinal strain. Secondary objectives include the assessment of biventricular and atrial function, cardiac and non-cardiac biomarkers, recovery patterns after ultra-endurance exercise, and the influence of race distance, training level, performance level, and sex on cardiovascular responses.

This exploratory single-center study conducted in France seeks to provide an integrative characterization of cardiac adaptations to extreme endurance exercise and to generate physiological insights that may guide future research and cardiovascular monitoring strategies in endurance athletes.

详细描述

Ultra-endurance running has gained increasing popularity, yet its acute cardiovascular effects remain incompletely characterized. Previous studies in endurance athletes have reported transient changes in myocardial function and elevations in cardiac biomarkers after prolonged exercise, but available data in ultra-trail settings remain limited and heterogeneous. Most prior investigations relied on pre- and post-race comparisons, small sample sizes, or incomplete assessment of right ventricular and atrial function, and rarely integrated multimodal echocardiographic imaging with standardized biological analyses.

The ULTRA-ECHO study is a prospective observational physiology study designed to investigate acute and short-term cardiovascular adaptations to ultra-endurance exercise under real-life conditions. Adult runners participating in the "Trail des Échos" ultra-trail race (80 km or 160 km) will undergo standardized transthoracic echocardiography, clinical evaluation, and biological sampling at predefined time points, including baseline screening, pre-effort, during the race, immediately after exercise, and during early recovery approximately one week after the event. Echocardiographic acquisitions will be performed using standardized imaging protocols on identical ultrasound systems, with centralized offline analysis and blinded secondary review in order to ensure reproducibility and minimize operator-related bias.

The primary focus of the study is the assessment of left ventricular global longitudinal strain (GLS), a sensitive marker of subclinical systolic myocardial function that may detect exercise-induced myocardial fatigue even when conventional ejection fraction remains preserved. Secondary evaluations include comprehensive structural and functional echocardiographic parameters of the left ventricle, right ventricle, and left atrium, as well as cardiac and systemic biological responses to prolonged endurance exercise.

This exploratory before-after design does not include a control group, as each participant serves as their own control through repeated within-subject assessments. The study also aims to explore potential modifiers of cardiovascular responses, including race distance, finisher status, training level, performance level, and sex. By integrating sequential imaging, biomarker analysis, and early follow-up evaluation, ULTRA-ECHO seeks to improve understanding of transient cardiac adaptations and recovery dynamics associated with ultra-endurance exercise and to generate physiological insights that may inform future research and cardiovascular monitoring strategies in endurance athletes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adults aged ≥18 years
  • Registered participants in the "Trail des Échos" ultra-trail race (80 km or 160 km)
  • Valid health clearance according to French Athletics Federation requirements
  • Affiliation with a national health insurance system
  • Able to understand study procedures and provide written informed consent

排除标准

  • Known or suspected cardiovascular disease at screening, including coronary artery disease, heart failure, clinically significant arrhythmias, moderate-to-severe valvular disease, uncontrolled hypertension, or prior stroke
  • Acute infection or unstable chronic medical condition (e.g., uncontrolled diabetes, renal, hepatic, respiratory, thyroid, or inflammatory disease)
  • Current treatments that may interfere with cardiovascular or biological assessments (including renin-angiotensin-aldosterone system blockers, chronic diuretics, anticoagulants, or systemic corticosteroids)
  • Use of systemic non-steroidal anti-inflammatory drugs within 3 days before the race or planned during the event
  • Participation in another ultra-endurance race (≥80 km) within 7 days before or after the study race
  • Pregnancy or breastfeeding
  • Inability to provide informed consent or legal protection status
  • Participation in another interventional clinical study

研究组 & 干预措施

Ultra-Endurance Runners

Adult amateur runners participating in ultra-trail races (80 km or 160 km) undergoing prospective echocardiographic and biological assessments to evaluate acute cardiovascular adaptations to ultra-endurance exercise.

结局指标

主要结局

Left Ventricular Global Longitudinal Strain (GLS)

时间窗: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)

Left ventricular global longitudinal strain measured by transthoracic echocardiography using speckle-tracking analysis. Image acquisition is standardized and analyzed centrally with blinded secondary review to assess subclinical systolic myocardial function in ultra-endurance runners.

次要结局

  • Structural echocardiographic parameters, ventricular volumes, and myocardial strain(Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3))
  • Echocardiographic assessment of systolic and diastolic function(Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3))
  • Echocardiographic assessment of pulmonary pressures(Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3))
  • Serum high-sensitivity troponin levels(Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3))
  • Serum NT-proBNP levels(Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3))
  • Serum creatine kinase levels(Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3))
  • Number of participants with abnormal non-cardiac biological laboratory findings(Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
  • Cardiovascular recovery assessed by transthoracic echocardiography(Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race))
  • Cardiovascular recovery assessed by serum cardiac biomarkers(Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race))

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

PACE Nathalie

MD, Cardiologist, Principal Investigator

Central Hospital, Nancy, France

研究点 (1)

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