Identifying sex-specific biological markers in valvular heart disease
Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease
This study is testing if special heart scans can help find different biological markers for men and women with aortic valve disease to improve treatment and recovery after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06780241 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with suspected moderate to severe aortic regurgitation or aortic stenosis.
Not a fit: Patients with acute traumatic cardiac injury, congenital heart diseases, or contraindications to cardiac MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with valvular heart disease based on their sex.
How similar studies have performed: Other studies have shown success in identifying sex differences in cardiovascular outcomes, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.