Healthy VolunteerCOEURNCT07372859
Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners
A study testing Echocardiography, Arterial ultrasound and Blood sampling in people with Healthy Volunteer, run by French Cardiology Society at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Echocardiography, Arterial ultrasound and Blood sampling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2027to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Henri Mondor, APHP
Créteil
Thomas D'HUMIERES, MD, thomas.d'humieres@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- Echocardiography, Arterial ultrasound, Blood sampling, Scales and questionnaire, Vital signs
- Keywords
- ultra endurance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
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 ultrasoundProcedure or surgery
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 samplingBiological
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 questionnaireBehavioural
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 signsProcedure or surgery
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 testBiological
Pregnancy test will be performed before the race.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race. Receives: Procedure: Echocardiography; Procedure: Arterial ultrasound; Biological: Blood sampling; Behavioral: Scales and questionnaire; Procedure: Vital signs; Biological: Urinary test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function
Echocardiographic measurements of left ventricular ejection fraction as a percentage
Measured: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Systemic inflammatory parameters
Inflammatory profile adjusted for baseline
Measured: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Secondary outcomes (3)
Hormonal parameters
Hormonal profile adjusted for baseline
Measured: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Vascular adaptations
Carotid artery and femoral artery diameter adjusted for baseline
Measured: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.
Defense mechanisms regarding emotional dynamics
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".
Measured: Before the race, at the 3 refreshment stations, at the arrival of the race.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start20 Mar 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain JOUFFROY, MD, Principal investigator, CHU d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372859
- Sponsor's protocol ID
- 2025-01
- Acronym
- COEUR
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners
- ClinicalTrials.gov ID
- NCT07372859
- Acronym / sponsor ID
- COEUR / 2025-01
- Conditions
- Healthy Volunteer
- Keywords
- ultra endurance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 20 Mar 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Echocardiography, Procedure: Arterial ultrasound, Biological: Blood sampling, Behavioral: Scales and questionnaire, Procedure: Vital signs, Biological: Urinary testParticipants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have a Global Positioning System watch during the race;
- Must participate in one of the following races:
- Must comply with the race regulations:
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography6 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 or surgery | Intervention group |
| Arterial ultrasound6 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. | Procedure or surgery | Intervention group |
| Blood sampling6 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. | Biological | Intervention group |
| Scales and questionnaireBefore 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. | Behavioural | Intervention group |
| Vital signs6 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. | Procedure or surgery | Intervention group |
| Urinary testPregnancy test will be performed before the race. | Biological | Intervention group |
Primary outcome
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
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
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain JOUFFROY, MD principal investigator
CHU d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography, Arterial ultrasound and Blood sampling in people with Healthy Volunteer, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tessa BERGOT, MSc (+33144907033, tessa.bergot@sfcariod.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac function (time frame: Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.