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Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

NCT06780241 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-01-02

No results posted yet for this study

Summary

This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping.

The aim to use standard and advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is to determine advanced CMR predictors of reverse remodeling following aortic valve surgery and develop sex-specific thresholds for risk. Infrastructure developed by this study will enable development of an innovative, scalable, sex-specific precision medicine cardiovascular imaging pipeline to determine overall risk and treatment response.

Conditions

  • Aortic Regurgitation
  • Mitral Regurgitation
  • Aortic Stenosis

Interventions

DIAGNOSTIC_TEST

CMR

CMR (with contrast at baseline and non-contrast at follow-up)

OTHER

Quality of Life Questionnaire

Rapid Assessment of Physical Activity questionnaire and the Kansas City Cardiomyopathy Questionnaire

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Deborah Kwon, MD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780241 on ClinicalTrials.gov