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NCT Number: NCT07372859

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiography

Procedure

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.

Arterial ultrasound

Procedure

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.

Blood sampling

Biological

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.

Scales and questionnaire

Behavioral

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.

vital signs

Procedure

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.

Urinary test

Biological

Pregnancy test will be performed before the race.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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".

Study contacts

Contact information is provided by the study sponsor or research team.

Tessa BERGOT, MSc

CONTACT

[email protected]

+33144907033

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: COEUR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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