NCT06780241 Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease
| NCT ID | NCT06780241 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Aortic Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-12-10 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Deborah Kwon, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06780241 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Aortic Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06780241 currently recruiting?
Yes, NCT06780241 is actively recruiting participants. Contact the research team at kwond@ccf.org for enrollment information.
Where is the NCT06780241 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06780241 clinical trial?
NCT06780241 is sponsored by The Cleveland Clinic. The principal investigator is Deborah Kwon, MD at The Cleveland Clinic. The trial plans to enroll 200 participants.