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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Cardiac function [Time frame: 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.]

Secondary outcome measures (3)

• Hormonal parameters [Time frame: 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.]
• Defense mechanisms regarding emotional dynamics [Time frame: Before the race, at the 3 refreshment stations, at the arrival of the race.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Hôpital Henri Mondor, APHP — Créteil

Identifiers

NCT: NCT07372859 · 2025-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗