NCT07372859

Brief Summary

The goal of this clinical trial is to describe the cardiac and systemic inflammatory adaptations specific to women practicing ultra-endurance sports. The objectives are to:

  • Improve the understanding of cardiac and systemic inflammatory adaptations specific to women participating in ultra-endurance sports.
  • Assess the relationship between observed cardiac and systemic inflammatory alterations and the relative levels of estrogen, testosterone, and progesterone.
  • Describe the vascular adaptations specific to women participating in ultra-endurance sports.
  • Examine the influence of defense mechanisms on the emotional dynamics observed during and after an ultra-endurance race.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Sep 2026

First Submitted

Initial submission to the registry

January 6, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 6, 2026

Last Update Submit

January 23, 2026

Conditions

Healthy Volunteer

Keywords

ultra endurance

Outcome Measures

Primary Outcomes (2)

  • Cardiac function

    Echocardiographic measurements of left ventricular ejection fraction as a percentage

    Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.

  • Systemic inflammatory parameters

    Inflammatory profile adjusted for baseline

    Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.

Secondary Outcomes (3)

  • Hormonal parameters

    Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.

  • Vascular adaptations

    Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.

  • Defense mechanisms regarding emotional dynamics

    Before the race, at the 3 refreshment stations, at the arrival of the race.

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.

Procedure: EchocardiographyProcedure: Arterial ultrasoundBiological: Blood samplingBehavioral: Scales and questionnaireProcedure: Vital signsBiological: Urinary test

Interventions

EchocardiographyPROCEDURE

6 transthoracic echocardiography will be performed: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.

Intervention group
Arterial ultrasoundPROCEDURE

6 ultrasound of the carotid and femoral arteries will be performed: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.

Intervention group
Blood samplingBIOLOGICAL

6 blood sampling (2 milliliters) will be performed: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.

Intervention group
Vital signsPROCEDURE

6 measurements of blood pressure, heart rate, respiratory rate, pulse oxygen saturation, and muscle oxygen saturation will then be taken: 1 before the race, 3 during the race (refreshment station), 1 at the end of the race, 1 at the follow up visit 9 days after the race. It is not possible to specify the intervention time, as this depends on the participants' running pace.

Intervention group
Scales and questionnaireBEHAVIORAL

Before the race, during the race (refreshment station), and at the end of the race participant will be asked to complete the study questionnaire and scales. It is not possible to specify the intervention time, as this depends on the participants' running pace.

Intervention group
Urinary testBIOLOGICAL

Pregnancy test will be performed before the race.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have a Global Positioning System watch during the race;
  • Must participate in one of the following races:
  • "Ecotrail de Paris Ile France©" (=a trail running race in the Paris region, it is not possible to translate; it is a registered trademark) 80 kilometers;
  • Or "la 6000D©" 69 kilometers;
  • Must comply with the race regulations:
  • Medical certificate stating no contraindications to competitive running, dated less than 12 months prior to the race;
  • Or a valid sports license on the day of the race.
  • Must agree to participate in the study, sign the consent form, and allow the sponsor to use their data for the purposes of this study.

You may not qualify if:

  • Refusal or linguistic or mental incapacity to sign the informed consent form;
  • Person under guardianship (conservatorship, curators, or legal protection) or deprived of liberty;
  • Person not affiliated with a social security scheme;
  • Pregnant woman;
  • Person participating in a drug study;
  • Women with a medical history (chronic lung disease, heart disease, pharmacologically treated hypertension) or with a known significant chronic inflammatory disease at the time of the enrollment visit;
  • Person who has already participated in this study in a previous race.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Henri Mondor, APHP

Créteil, France

Location

MeSH Terms

Interventions

Blood Specimen CollectionWeights and MeasuresSurveys and QuestionnairesAntibody-Coated Bacteria Test, Urinary

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthFluorescent Antibody TechniqueImmunohistochemistryHistocytochemistryCytological TechniquesHistological TechniquesImmunologic TestsDiagnostic Techniques, UrologicalImmunologic Techniques

Study Officials

  • Romain JOUFFROY, MD

    CHU d'Orléans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tessa BERGOT, MSc

CONTACT

+33144907033tessa.bergot@sfcariod.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 28, 2026

Study Start

March 22, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

FR(1)