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Observational Study of Sex-Specific Signatures in Valvular Heart Disease

This study is looking at how heart valve diseases like aortic regurgitation, mitral regurgitation, and aortic stenosis affect men and women differently. Researchers will use special heart scans called CMR (Cardiac Magnetic Resonance) with and without contrast dye, along with quality of life questionnaires, to understand these differences. The goal is to see how the heart changes over time, specifically looking at changes in the size of the heart's pumping chamber (LV Dilation) and how well it pumps (LVEF) after 6-12 months. You might be able to join if you are between 18 and 90 years old and have suspected moderate or severe heart valve disease. This study aims to improve how we understand and treat heart valve disease for both men and women.

Study design
This is an observational study, meaning participants will be monitored without receiving a specific intervention. It plans to enroll 200 participants.
What's involved
Participants will undergo CMR scans at the beginning and at a follow-up visit, and complete quality of life questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6-12 months to measure changes in heart function.

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NCT06780241

Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease

Recruiting
Not specifiedAges 18–90Observational
The Cleveland Clinic
~200 participants
Updated 2026-01-02 on ClinicalTrials.gov
What's tested:CMRQuality of Life Questionnaire

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in LV Dilation and/or change in LVEF
Measured over 6-12 months

Conditions

Aortic Regurgitation
Mitral Regurgitation
Aortic Stenosis

Explore related trials

Aortic Valve InsufficiencyAortic Valve StenosisMitral Valve Insufficiency

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Deborah Kwon, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Deborah Kwon, MD
[email protected]
216-444-8526
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in LV Dilation and/or change in LVEF6-12 months

    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%