- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07753694
Acute Cardiac Effects of Ultra-Trail Running (ULTRA-ECHO)
Echocardiographic Assessment of the Acute Impact of an Ultra-Trail Race on Cardiac Function
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Nathalie Pace, MD
- Telefonní číslo: +33383157352
- E-mail: n.pace@chru-nancy.fr
Studijní záloha kontaktů
- Jméno: Ninon Mougel, MD
- E-mail: n.mougel@chru-nancy.fr
Studijní místa
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Meurthe-et-Moselle
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Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Francie, 54511
- Centre Hospitalier Régional Universitaire de Nancy
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Kontakt:
- Nathalie Pace, MD
- Telefonní číslo: +33383157352
- E-mail: n.pace@chru-nancy.fr
-
Kontakt:
- Ninon Mougel, MD
- E-mail: n.mougel@chru-nancy.fr
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Vrchní vyšetřovatel:
- Nathalie Pace, MD
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Dílčí vyšetřovatel:
- Ninon Mougel, MD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Left Ventricular Global Longitudinal Strain (GLS)
Časové okno: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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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.
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Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Structural echocardiographic parameters, ventricular volumes, and myocardial strain
Časové okno: 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)
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Assessment of left and right ventricular sizes and volumes (millimeters or milliliters), left atrial dimensions (millimeters or milliliters per square meter) and function, alongside right ventricular free-wall strain (percentage), measured by standardized transthoracic echocardiography
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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)
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Echocardiographic assessment of systolic and diastolic function
Časové okno: 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)
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Assessment of left and right ventricular systolic and diastolic function, including FAC (percentage), TAPSE (millimeters), and S' wave (centimeters per second), measured by standardized transthoracic echocardiography
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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)
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Echocardiographic assessment of pulmonary pressures
Časové okno: 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)
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Assessment of pulmonary pressures (millimeters of mercury) measured by standardized transthoracic echocardiography
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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)
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Serum high-sensitivity troponin levels
Časové okno: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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Measurement of serum high-sensitivity troponin levels (nanograms per liter) to evaluate myocardial stress
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Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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Serum NT-proBNP levels
Časové okno: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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Measurement of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (picograms per milliliter) to evaluate cardiac wall stretch
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Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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Serum creatine kinase levels
Časové okno: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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Measurement of serum creatine kinase levels (units per liter) to evaluate skeletal or myocardial muscle damage
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Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
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Number of participants with abnormal non-cardiac biological laboratory findings
Časové okno: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3
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Number of participants presenting with laboratory values outside the standard reference ranges for systemic biological responses, including electrolytes, creatinine, complete blood count, and lactate
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Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3
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Cardiovascular recovery assessed by transthoracic echocardiography
Časové okno: Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
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Evaluation of myocardial structural and functional recovery, specifically tracking changes in right ventricular free-wall strain (percentage), ventricular volumes (milliliters), and diastolic velocities (centimeters per second) between the end of the race and follow-up
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Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
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Cardiovascular recovery assessed by serum cardiac biomarkers
Časové okno: Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
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Evaluation of cardiac biomarker clearance and recovery, specifically tracking changes in high-sensitivity troponin levels (nanograms per liter) and NT-proBNP levels (picograms per milliliter) between the end of the race and follow-up
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Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Nathalie Pace, MD, CHRU de Nancy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-A02579-40
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Plánujete sdílet data jednotlivých účastníků (IPD)?
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