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Acute Cardiac Effects of Ultra-Trail Running (ULTRA-ECHO)

4 augustus 2026 bijgewerkt door: PACE Nathalie, Central Hospital, Nancy, France

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

60

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Frankrijk
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, Frankrijk, 54511
        • Centre Hospitalier Régional Universitaire de Nancy
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Nathalie Pace, MD
        • Onderonderzoeker:
          • Ninon Mougel, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adult ultra-endurance runners participating in the "Trail des Échos" ultra-trail race (80 km or 160 km), screened prior to participation and recruited to investigate physiological cardiovascular adaptations to prolonged endurance exercise in individuals without known cardiovascular disease.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Left Ventricular Global Longitudinal Strain (GLS)
Tijdsspanne: 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.
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Structural echocardiographic parameters, ventricular volumes, and myocardial strain
Tijdsspanne: 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)
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
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
Tijdsspanne: 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)
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
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
Tijdsspanne: 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)
Assessment of pulmonary pressures (millimeters of mercury) measured by standardized transthoracic echocardiography
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
Tijdsspanne: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Measurement of serum high-sensitivity troponin levels (nanograms per liter) to evaluate myocardial stress
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Serum NT-proBNP levels
Tijdsspanne: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Measurement of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (picograms per milliliter) to evaluate cardiac wall stretch
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Serum creatine kinase levels
Tijdsspanne: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Measurement of serum creatine kinase levels (units per liter) to evaluate skeletal or myocardial muscle damage
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
Tijdsspanne: Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3
Number of participants presenting with laboratory values outside the standard reference ranges for systemic biological responses, including electrolytes, creatinine, complete blood count, and lactate
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
Tijdsspanne: Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
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
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
Tijdsspanne: Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
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
Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Central Hospital, Nancy, France

Medewerkers

Association PACElab

Onderzoekers

  • Hoofdonderzoeker: Nathalie Pace, MD, CHRU de Nancy

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2027

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

22 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 augustus 2026

Eerst geplaatst (Werkelijk)

7 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-A02579-40

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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