Identifying sex-specific biological markers in valvular heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to validate sex-specific biological signatures associated with aortic valve disease using advanced cardiac magnetic resonance (CMR) techniques. By employing methods such as Magnetic Resonance Fingerprinting (MRF), Diffusion Tensor Imaging (DTI), and radiomics analysis, the study seeks to identify predictors of reverse remodeling following aortic valve surgery. The goal is to develop sex-specific thresholds for risk and treatment response, addressing the current lack of consideration for sex differences in existing guidelines for valvular heart disease. The infrastructure created will support a precision medicine approach in cardiovascular imaging.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Deborah Kwon, MD — The Cleveland Clinic
• Study coordinator: Deborah Kwon, MD
• Email: kwond@ccf.org
• Phone: 216-444-8526

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.