Myocardial StiffnessNCT06475768
The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.
An observational study of Myocardial Stiffness, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Stiffness
- What is being tested?
- Stress Echocardiogram, Cardiovascular Magnetic Imaging (cMRI) and Cardiac Magnetic Resonance Elastography (cMRE)
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2024to 6 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myocardial Stiffness
- Being tested
- Stress Echocardiogram, Cardiovascular Magnetic Imaging (cMRI), Cardiac Magnetic Resonance Elastography (cMRE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress EchocardiogramDiagnostic test
Exercise testing via treadmill with simultaneous gas exchange analysis and pre- and post-exercise transthoracic echocardiography.
Cardiovascular Magnetic Imaging (cMRI)Diagnostic test
Non-invasive imaging scan used to examine function and structure of the heart
Cardiac Magnetic Resonance Elastography (cMRE)Diagnostic test
Non-invasive imaging scan used to measure myocardial stiffness
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal Female Athletes | Not described Receives: Diagnostic Test: Stress Echocardiogram; Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI); Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE) | |
| Postmenopausal Female Athletes | Not described Receives: Diagnostic Test: Stress Echocardiogram; Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI); Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE) | |
| Male Athletes | Not described Receives: Diagnostic Test: Stress Echocardiogram; Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI); Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial stiffness
Myocardial stiffness will be measured by magnetic resonance elastography (kPa)
Measured: Day 14
Secondary outcomes (2)
Left ventricular filling pressures with exercise
Left ventricular filling pressures with exercise will be measured by stress echocardiography
Measured: Baseline
Exercise capacity
Exercise capacity will be measured by stress echocardiography
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start14 Sep 2024
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial StiffnessStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn F. Larson, Mayo Clinic
- Investigators
- Kathryn Larson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475768
- Sponsor's protocol ID
- 24-001460
- Status last verified
- Nov 2025
- First submitted
- 21 Jun 2024
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.
- ClinicalTrials.gov ID
- NCT06475768
- Acronym / sponsor ID
- 24-001460
- Conditions
- Myocardial Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 26 Jun 2024 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Premenopausal Female Athletes | – | Diagnostic Test: Stress Echocardiogram, Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI), Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE) |
| Postmenopausal Female Athletes | – | Diagnostic Test: Stress Echocardiogram, Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI), Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE) |
| Male Athletes | – | Diagnostic Test: Stress Echocardiogram, Diagnostic Test: Cardiovascular Magnetic Imaging (cMRI), Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Stress EchocardiogramExercise testing via treadmill with simultaneous gas exchange analysis and pre- and post-exercise transthoracic echocardiography. | Diagnostic test | Male Athletes, Postmenopausal Female Athletes, Premenopausal Female Athletes |
| Cardiovascular Magnetic Imaging (cMRI)Non-invasive imaging scan used to examine function and structure of the heart | Diagnostic test | Male Athletes, Postmenopausal Female Athletes, Premenopausal Female Athletes |
| Cardiac Magnetic Resonance Elastography (cMRE)Non-invasive imaging scan used to measure myocardial stiffness | Diagnostic test | Male Athletes, Postmenopausal Female Athletes, Premenopausal Female Athletes |
Primary outcome
Myocardial stiffness
Time frame: Day 14
Myocardial stiffness will be measured by magnetic resonance elastography (kPa)
2 secondary outcomes
Left ventricular filling pressures with exercise
Time frame: Baseline
Exercise capacity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
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Noninvasive Elastography Evaluation of Myocardial Stiffness in Elderly Patients With Isolated Diastolic Heart Failure: New Diagnostic Tool?
Cardiovascular Diseases in Old Age
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Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction
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The Effect of Sodium Glucose Co-trnasportert Type 2 Inhibitors on Arterial Stiffness, Endothelial Glycocalyx Thickness and Cardiac Deformation After Acute Myocardial Infarction
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The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Myocardial Deformation
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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. This study is not recruiting at the moment.
Kathryn Larson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Stiffness, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 6 Nov 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial stiffness (time frame: Day 14). 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 6 Nov 2025.