Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-01 @ 1:28 PM
Study NCT ID:
NCT06475768
Status:
COMPLETED
Last Update Posted:
2025-11-06
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D025401', 'term': 'Echocardiography, Stress'}], 'ancestors': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial stiffness', 'timeFrame': 'Day 14', 'description': 'Myocardial stiffness will be measured by magnetic resonance elastography (kPa)'}], 'secondaryOutcomes': [{'measure': 'Left ventricular filling pressures with exercise', 'timeFrame': 'Baseline', 'description': 'Left ventricular filling pressures with exercise will be measured by stress echocardiography'}, {'measure': 'Exercise capacity', 'timeFrame': 'Baseline', 'description': 'Exercise capacity will be measured by stress echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Stiffness']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to study postmenopausal female masters athletes to see if they will show greater myocardial stiffness and reduced exercise capacity than premenopausal females and similarly aged male masters athletes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Masters athletes (40-70 yrs of age) with a longstanding history of competitive endurance athletic performance defined as \\>15 years of continuous athletic training for at least 7 hours per week, and ongoing engagement in competitive events, will be recruited from Mayo registry and from the local athletic community via brochures within the Dan Abraham Healthy Living Center and the Mayo Clinic Classifieds.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Longstanding history of competitive endurance athletic performance defined as \\>15 years of continuous athletic training for at least 7 hours per week and ongoing engagement in competitive events.\n\nExclusion Criteria:\n\n* A current or prior diagnosis of cardiovascular disease as defined by the presence of structural heart disease, heart failure, symptomatic coronary artery disease, more than moderate valve disease or prior valve surgery,\n* Current or recent pregnancy within 1 year\n* Positive pregnancy test (study visit 1)\n* Concurrent or use within 1 year of oral contraceptives or hormone replacement therapy,\n* Unable to undergo a cMRI (Please refer standard clinical contraindications for MRI)'}, 'identificationModule': {'nctId': 'NCT06475768', 'briefTitle': 'The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.', 'orgStudyIdInfo': {'id': '24-001460'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Premenopausal Female Athletes', 'interventionNames': ['Diagnostic Test: Stress Echocardiogram', 'Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI)', 'Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE)']}, {'label': 'Postmenopausal Female Athletes', 'interventionNames': ['Diagnostic Test: Stress Echocardiogram', 'Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI)', 'Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE)']}, {'label': 'Male Athletes', 'interventionNames': ['Diagnostic Test: Stress Echocardiogram', 'Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI)', 'Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE)']}], 'interventions': [{'name': 'Stress Echocardiogram', 'type': 'DIAGNOSTIC_TEST', 'description': 'Exercise testing via treadmill with simultaneous gas exchange analysis and pre- and post-exercise transthoracic echocardiography.', 'armGroupLabels': ['Male Athletes', 'Postmenopausal Female Athletes', 'Premenopausal Female Athletes']}, {'name': 'Cardiovascular Magnetic Imaging (cMRI)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Non-invasive imaging scan used to examine function and structure of the heart', 'armGroupLabels': ['Male Athletes', 'Postmenopausal Female Athletes', 'Premenopausal Female Athletes']}, {'name': 'Cardiac Magnetic Resonance Elastography (cMRE)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Non-invasive imaging scan used to measure myocardial stiffness', 'armGroupLabels': ['Male Athletes', 'Postmenopausal Female Athletes', 'Premenopausal Female Athletes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Kathryn Larson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Consultant, Cardiovascular Medicine', 'investigatorFullName': 'Kathryn F. Larson', 'investigatorAffiliation': 'Mayo Clinic'}}}}