Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners (COEUR)

January 23, 2026 updated by: French Cardiology Society

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a French national non-comparative descriptive study. The study is conducted on healthy volunteers. 80 to 100 patients will be included, half of the inclusions on the "Ecotrail de Paris Ile France©"( = a trail running race in the Paris region. It is not possible to translate; it is a registered trademark) the second half of the inclusions on the "6000D©" in Savoie.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.
Procedure: Echocardiography
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.
Procedure: Arterial ultrasound
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.
Biological: Blood sampling
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.
Behavioral: Scales and questionnaire
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.
Procedure: Vital signs
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.
Biological: Urinary test
Pregnancy test will be performed before the race.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function
Time Frame: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
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
Time Frame: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hormonal parameters
Time Frame: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Hormonal profile adjusted for baseline
Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Vascular adaptations
Time Frame: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Carotid artery and femoral artery diameter adjusted for baseline
Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Defense mechanisms regarding emotional dynamics
Time Frame: Before the race, at the 3 refreshment stations, at the arrival of the race.
Defense Style Questionnaire-26 questionnaire is a standardized questionnaire developed to assess defense mechanisms: adaptive (humor, anticipation, self-assertion, altruism, self-observation) and maladaptive defenses (help rejecting complaining, splitting other, projection, dissociation, intellectualization, devaluation/self, fantasy, devaluation of other). These items are rated on a Likert scale from 1 to 6 points; 1 corresponding to "strongly disagree" and 6 to "strongly agree".
Before the race, at the 3 refreshment stations, at the arrival of the race.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Investigators

  • Principal Investigator: Romain JOUFFROY, MD, CHU d'Orléans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 22, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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