Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT06780241

Conditions

Aortic Regurgitation

Mitral Regurgitation

Aortic Stenosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CMR

Quality of Life Questionnaire

Study Details

Brief 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

Study ID

NCT06780241

Start date

Dec 10, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-90 years of age
  • Suspected moderate or severe (2-3+ or more) aortic regurgitation, or moderate or more aortic stenosis on the basis of prior known clinical history, echocardiogram or cardiac MRI.

Exclusion Criteria:

  • Acute traumatic cardiac injury
  • Aortic dissection or aortic root rupture
  • Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD
  • Presence of A-V fistula or intracardiac shunts
  • Any contraindications to cardiac MRI including:

  • Patients with any MR-incompatible implant, including cardiac pacemakers or defibrillators, or older types of cerebral aneurysm clips.
  • Patients who weigh more than 440 lbs. or have a very wide waist circumference.
  • Patients with claustrophobia may have difficulty tolerating the exam.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Intervention

Cardiac MRI (CMR) with Magnetic Resonance Fingerprinting (MRF), fSENC (a new CMR technology which may detect subclinical signs of myocardial damage by measuring myocardial strain), Diffusion Tensor imaging (DTI), and chemical exchange transfer imaging with contrast at baseline and without contrast at follow up.

Rapid Assessment of Physical Activity questionnaire Kansas City Cardiomyopathy Questionnaire

Interventions

CMR

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

Quality of Life Questionnaire

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

Primary outcome measure

  • Change in LV Dilation and/or change in LVEF [ Time Frame: 6-12 months ]

Central Contacts and Locations

Central contacts

Deborah Kwon, MD

216-444-8526kwond@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Degorah Kwon, MD

216-444-8526

Lydia DeAngelo

401-225-1929deangel2@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-01-02.