NCT06475768

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 14, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
Last Updated

November 6, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

June 21, 2024

Last Update Submit

November 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Myocardial stiffness

    Myocardial stiffness will be measured by magnetic resonance elastography (kPa)

    Day 14

Secondary Outcomes (2)

  • Left ventricular filling pressures with exercise

    Baseline

  • Exercise capacity

    Baseline

Study Arms (3)

Premenopausal Female Athletes

Diagnostic Test: Stress EchocardiogramDiagnostic Test: Cardiovascular Magnetic Imaging (cMRI)Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE)

Postmenopausal Female Athletes

Diagnostic Test: Stress EchocardiogramDiagnostic Test: Cardiovascular Magnetic Imaging (cMRI)Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE)

Male Athletes

Diagnostic Test: Stress EchocardiogramDiagnostic Test: Cardiovascular Magnetic Imaging (cMRI)Diagnostic Test: Cardiac Magnetic Resonance Elastography (cMRE)

Interventions

Stress EchocardiogramDIAGNOSTIC_TEST

Exercise testing via treadmill with simultaneous gas exchange analysis and pre- and post-exercise transthoracic echocardiography.

Male AthletesPostmenopausal Female AthletesPremenopausal Female Athletes

Non-invasive imaging scan used to examine function and structure of the heart

Male AthletesPostmenopausal Female AthletesPremenopausal Female Athletes

Non-invasive imaging scan used to measure myocardial stiffness

Male AthletesPostmenopausal Female AthletesPremenopausal Female Athletes

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Echocardiography, Stress

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Kathryn Larson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Consultant, Cardiovascular Medicine

Study Record Dates

First Submitted

June 21, 2024

First Posted

June 26, 2024

Study Start

September 14, 2024

Primary Completion

October 6, 2025

Study Completion

October 6, 2025

Last Updated

November 6, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations