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Not yet recruitingNCT07753694ULTRA-ECHOUpdated Aug 7, 2026

Acute Cardiac Effects of Ultra-Trail Running

An observational study in Exercise, Cardiac Function and Echocardiography, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 367 studies in Motor Activity with a site in France — 78 open to participants now, 90 under way, none of them phase 3. Motor Activity · France.

Planned enrollment
61st of 98
60 · median 98
Started
2027
with 1 other
Observational
98 of 367
25 open now
Primary completion
2027-05
later than 52 of 89 live
Registered
347th of 367
by date

Among the 367 studies in Motor Activity with a site in France, this one is the 61st largest by planned enrollment of the 98 observational ones, is one of 2 that started in 2027, is one of 98 observational ones, reaches primary completion later than 52 of the 89 other live ones, and was the 347th registered.

By phase

367 studies; the count open now beside each. This study's row is marked.

No phase254 · 52 open
Observationalthis study98 · 25 open
Phase 28 · 1 open
Phase 35 · 0 open
Phase 42 · 0 open

By the year they started

First in 1983; this study’s year is marked. 2 started in 2027.

Size and results

Median enrollment 62 across the 269 interventional studies, 98 across the 98 observational. Of the 230 that completed or were terminated, 3 (1%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 367 studies in Motor Activity with a site in France, or all of them as a file.
02

Study 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.

Read the detailed description

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.

03

Conditions studied

  • Exercise
  • Cardiac Function
  • Echocardiography

Browse trials for

Keywords

  • Ultra-endurance exercise
  • Ultra-trail running
  • Myocardial strain
  • Cardiac biomarkers
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Known or suspected cardiovascular disease at screening, including coronary artery disease, heart failure, 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 )
  • 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 or legal protection status
  • Participation in another interventional clinical study
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Structural echocardiographic parameters, ventricular volumes, and myocardial strain

    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

    Time frame: 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)

  2. Echocardiographic assessment of systolic and diastolic function

    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

    Time frame: 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)

  3. Echocardiographic assessment of pulmonary pressures

    Assessment of pulmonary pressures (millimeters of mercury) measured by standardized transthoracic echocardiography

    Time frame: 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)

  4. Serum high-sensitivity troponin levels

    Measurement of serum high-sensitivity troponin levels (nanograms per liter) to evaluate myocardial stress

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

  5. Serum NT-proBNP levels

    Measurement of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (picograms per milliliter) to evaluate cardiac wall stretch

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

  6. Serum creatine kinase levels

    Measurement of serum creatine kinase levels (units per liter) to evaluate skeletal or myocardial muscle damage

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

  7. Number of participants with abnormal non-cardiac biological laboratory findings

    Number of participants presenting with laboratory values outside the standard reference ranges for systemic biological responses, including electrolytes, creatinine, complete blood count, and lactate

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

  8. Cardiovascular recovery assessed by transthoracic echocardiography

    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

    Time frame: Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)

  9. Cardiovascular recovery assessed by serum cardiac biomarkers

    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

    Time frame: Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2027; primary completion for May 2027, 0 months later.

Of 490 non-industry observational studies under Motor Activity, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's planned 0 months is below that.

Counting every sponsor, half of 500 studies reached it within 22 months; a quarter within 8 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 22, 2026
First posted
Aug 7, 2026
StartEst.
May 2027
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07753694
Collaborators
Association PACElab
Responsible party
PACE Nathalie (MD, Cardiologist, Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Aug 7, 2026
Start date
May 2027 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Aug 7, 2026

Study contacts

Nathalie Pace, MD
Contact
n.pace@chru-nancy.fr
+33383157352
Ninon Mougel, MD
Contact
n.mougel@chru-nancy.fr
Nathalie Pace, MD
principal investigator · CHRU de Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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