Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

NCT06780241 | Recruiting

• 1 other identifier: 24-861
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Mitral Regurgitation; Aortic Stenosis; Aortic Regurgitation

Outcome Measures

Primary Outcomes (1)

• Change in LV Dilation and/or change in LVEF

  Significant change in LV remodeling will be defined as a change in EF by 10 units (reverse remodeling is defined at least 10 unit decrease) or change in LV end-diastolic/systolic volume by 10% (Reverse remodeling is defined as at least decrease in LV end-diastolic/systolic volume by 10%

  6-12 months

Secondary Outcomes (4)

• Change in Aortic Regurgiation

  6-12 months

• Change in BNP

  6-12 months

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

  6-12 months

• 6 minute walk test

  6-12 months

Study Arms (1)

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

Diagnostic Test: CMR; Other: Quality of Life Questionnaire

Interventions

CMR DIAGNOSTIC_TEST

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

Intervention

Quality of Life Questionnaire OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with at least moderate Aortic Stenosis or Aortic Regurgitation who are scheduled for a surgical repair or replacement of their aortic valve.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Aortic Valve Insufficiency; Mitral Valve Insufficiency; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Deborah Kwon, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Kwon, MD

CONTACT

216-444-8526; kwond@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (1)