- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06475768
The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.
November 4, 2025 updated by: Kathryn F. Larson, Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- Current or recent pregnancy within 1 year
- Positive pregnancy test (study visit 1)
- Concurrent or use within 1 year of oral contraceptives or hormone replacement therapy,
- Unable to undergo a cMRI (Please refer standard clinical contraindications for MRI)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Premenopausal Female Athletes
|
Exercise testing via treadmill with simultaneous gas exchange analysis and pre- and post-exercise transthoracic echocardiography.
Non-invasive imaging scan used to examine function and structure of the heart
Non-invasive imaging scan used to measure myocardial stiffness
|
|
Postmenopausal Female Athletes
|
Exercise testing via treadmill with simultaneous gas exchange analysis and pre- and post-exercise transthoracic echocardiography.
Non-invasive imaging scan used to examine function and structure of the heart
Non-invasive imaging scan used to measure myocardial stiffness
|
|
Male Athletes
|
Exercise testing via treadmill with simultaneous gas exchange analysis and pre- and post-exercise transthoracic echocardiography.
Non-invasive imaging scan used to examine function and structure of the heart
Non-invasive imaging scan used to measure myocardial stiffness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial stiffness
Time Frame: Day 14
|
Myocardial stiffness will be measured by magnetic resonance elastography (kPa)
|
Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Left ventricular filling pressures with exercise
Time Frame: Baseline
|
Left ventricular filling pressures with exercise will be measured by stress echocardiography
|
Baseline
|
|
Exercise capacity
Time Frame: Baseline
|
Exercise capacity will be measured by stress echocardiography
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathryn Larson, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2024
Primary Completion (Actual)
October 6, 2025
Study Completion (Actual)
October 6, 2025
Study Registration Dates
First Submitted
June 21, 2024
First Submitted That Met QC Criteria
June 21, 2024
First Posted (Actual)
June 26, 2024
Study Record Updates
Last Update Posted (Estimated)
November 6, 2025
Last Update Submitted That Met QC Criteria
November 4, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-001460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Stiffness
-
Wake Forest University Health SciencesCompletedif Aortic Stiffness | Myocardial Wall StrainUnited States
-
Chinese University of Hong KongNot yet recruitingArterial Stiffness
-
University of PrimorskaCompleted
-
Superior UniversityActive, not recruitingStiffness; SacroiliacPakistan
-
Riphah International UniversityCompleted
-
International Society for Vascular HealthCompleted
-
National Taiwan University HospitalUnknownMuscle StiffnessTaiwan
-
Selcuk UniversityCompletedLiver Stiffness | Spleen Stiffness | Shear Wave Elastography in Healthy Children | Normal Organ Elasticity | Pediatric ElastographyTurkey (Türkiye)
-
University Hospital, LilleMerck Sharp & Dohme LLC; Fédération Française de CardiologieActive, not recruitingMyocardial Infarction | Heart Failure | Vascular StiffnessFrance
-
Mayo ClinicEnrolling by invitation
Clinical Trials on Stress Echocardiogram
-
Memorial Sloan Kettering Cancer CenterWeill Medical College of Cornell UniversityCompletedHodgkin Lymphoma SurvivorUnited States
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedChest PainUnited States
-
Walter Reed Army Medical CenterUnknownCoronary Artery Disease | Chest Pain | Coronary Atherosclerosis | Stress TestingUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
University of East AngliaNorfolk and Norwich University Hospitals NHS Foundation Trust; British Medical...Unknown
-
Weill Medical College of Cornell UniversityRecruitingFriedreich's AtaxiaUnited States
-
Kaiser PermanenteEnrolling by invitationEchocardiography, Transthoracic | Echocardiographic SoftwareUnited States
-
Duke UniversityFogarty International Center of the National Institute of Health; Duke Center... and other collaboratorsCompleted
-
CryoLife, Inc.CompletedAortic Valve Stenosis | Aortic Valve Insufficiency | Pulmonary Valve Insufficiency | Pulmonary Valve StenosisUnited States
-
CryoLife, Inc.CompletedAortic Valve Stenosis | Aortic Valve InsufficiencyUnited States