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Clinical Trials in France / NCT07372859
Starting soon Not applicable

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

NCT07372859 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-03-22
Last updated
2026-01-28

Condition(s) studied

Healthy Volunteer

Investigational drug(s) / intervention(s)

EchocardiographyArterial ultrasoundBlood sampling →Scales and questionnaireVital signsUrinary test

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.

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.

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.

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.

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.

Urinary test: Pregnancy test will be performed before the race.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Henri Mondor, APHP Créteil France

More French Cardiology Society trials in France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07372859 on ClinicalTrials.gov ↗ ← All trials in France