Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:21 AM
Study NCT ID:
NCT07372859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D014894', 'term': 'Weights and Measures'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D000919', 'term': 'Antibody-Coated Bacteria Test, Urinary'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D005455', 'term': 'Fluorescent Antibody Technique'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac function', 'timeFrame': 'Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.', 'description': 'Echocardiographic measurements of left ventricular ejection fraction as a percentage'}, {'measure': 'Systemic inflammatory parameters', 'timeFrame': 'Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.', 'description': 'Inflammatory profile adjusted for baseline'}], 'secondaryOutcomes': [{'measure': 'Hormonal parameters', 'timeFrame': 'Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.', 'description': 'Hormonal profile adjusted for baseline'}, {'measure': 'Vascular adaptations', 'timeFrame': 'Before the race, at the 3 refreshment stations, at the arrival of the race, 9 days after the race.', 'description': 'Carotid artery and femoral artery diameter adjusted for baseline'}, {'measure': 'Defense mechanisms regarding emotional dynamics', 'timeFrame': 'Before the race, at the 3 refreshment stations, at the arrival of the race.', 'description': '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".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultra endurance'], 'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to describe the cardiac and systemic inflammatory adaptations specific to women practicing ultra-endurance sports.\n\nThe objectives are to:\n\n* Improve the understanding of cardiac and systemic inflammatory adaptations specific to women participating in ultra-endurance sports.\n* Assess the relationship between observed cardiac and systemic inflammatory alterations and the relative levels of estrogen, testosterone, and progesterone.\n* Describe the vascular adaptations specific to women participating in ultra-endurance sports.\n* Examine the influence of defense mechanisms on the emotional dynamics observed during and after an ultra-endurance race.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a Global Positioning System watch during the race;\n* Must participate in one of the following races:\n\n * "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;\n * Or "la 6000D©" 69 kilometers;\n* Must comply with the race regulations:\n\n * Medical certificate stating no contraindications to competitive running, dated less than 12 months prior to the race;\n * Or a valid sports license on the day of the race.\n* 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.\n\nExclusion Criteria:\n\n* Refusal or linguistic or mental incapacity to sign the informed consent form;\n* Person under guardianship (conservatorship, curators, or legal protection) or deprived of liberty;\n* Person not affiliated with a social security scheme;\n* Pregnant woman;\n* Person participating in a drug study;\n* 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;\n* Person who has already participated in this study in a previous race.'}, 'identificationModule': {'nctId': 'NCT07372859', 'acronym': 'COEUR', 'briefTitle': "Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners", 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': "Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female Runners", 'orgStudyIdInfo': {'id': '2025-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants will undergo examination before the race, during the race, at the arrival of the race, and 9 days after the race.', 'interventionNames': ['Procedure: Echocardiography', 'Procedure: Arterial ultrasound', 'Biological: Blood sampling', 'Behavioral: Scales and questionnaire', 'Procedure: Vital signs', 'Biological: Urinary test']}], 'interventions': [{'name': 'Echocardiography', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Intervention group']}, {'name': 'Arterial ultrasound', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Intervention group']}, {'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': "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.", 'armGroupLabels': ['Intervention group']}, {'name': 'Scales and questionnaire', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Intervention group']}, {'name': 'Vital signs', 'type': 'PROCEDURE', 'description': "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.", 'armGroupLabels': ['Intervention group']}, {'name': 'Urinary test', 'type': 'BIOLOGICAL', 'description': 'Pregnancy test will be performed before the race.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Créteil', 'country': 'France', 'contacts': [{'name': "Thomas D'HUMIERES, MD", 'role': 'CONTACT', 'email': "thomas.d'humieres@aphp.fr"}], 'facility': 'Hôpital Henri Mondor, APHP', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'centralContacts': [{'name': 'Tessa BERGOT, MSc', 'role': 'CONTACT', 'email': 'tessa.bergot@sfcariod.fr', 'phone': '+33144907033'}], 'overallOfficials': [{'name': 'Romain JOUFFROY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "CHU d'Orléans"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}