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

French Cardiology Society

Status: Begins enrollment in 1 month

Conditions: Healthy Volunteer

Treatments: Procedure: Arterial ultrasound; Procedure: Vital signs; Behavioral: Scales and questionnaire; Procedure: Echocardiography; Biological: Urinary test; Biological: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT07372859

2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Intervention group

Experimental group

Description:

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

Treatment:

Biological: Blood sampling

Biological: Urinary test

Procedure: Echocardiography

Procedure: Vital signs

Behavioral: Scales and questionnaire

Procedure: Arterial ultrasound