Acute Cardiac Effects of Ultra-Trail Running

NCT07753694 | Not Yet Recruiting

• 1 other identifier: 2025-A02579-40
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Echocardiography; Exercise; Cardiac Function

Keywords

Ultra-endurance exercise; Ultra-trail running; Myocardial strain; Cardiac biomarkers

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Global Longitudinal Strain (GLS)

  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)

Secondary Outcomes (9)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Association PACElab: collaborator

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nathalie Pace, MD

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Pace, MD

CONTACT

+33383157352; n.pace@chru-nancy.fr

Ninon Mougel, MD

CONTACT

n.mougel@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Cardiologist, Principal Investigator

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): May 1, 2027
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

FR (1)