Examining symptoms and severity of mitral regurgitation
Official title: Assessing the Impact of Diastolic Dysfunction on the Presence of Symptoms in Patients with Primary Mitral Regurgitation.
Run by Atlantic Health System · NCT06738615 · Data updated 2026-11-12
This study is trying to understand how symptoms and heart function relate in patients with mitral regurgitation who are getting ready for heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 40 (estimated) |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 1 site (Morristown, New Jersey) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | January 2, 2027 |
| Study ends | May 2, 2027 |
| Registry record updated | December 17, 2024 |
| Trial ID | NCT06738615 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with primary degenerative mitral regurgitation and a left ventricular ejection fraction of 50% or greater who are scheduled for cardiac catheterization.
✕Probably not a fit
Patients with secondary mitral regurgitation, those with a left ventricular ejection fraction below 50%, or those with significant coronary artery disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with mitral regurgitation who are undergoing left heart catheterization prior to mitral valve surgery or intervention. Participants will undergo a series of evaluations including cardiovascular magnetic resonance imaging (CMR), cardiopulmonary exercise testing (CPET), and the Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess their symptoms, exercise capacity, and the severity of their condition. The study aims to explore the relationship between diastolic dysfunction and symptoms in patients with mitral regurgitation, providing insights into how these factors interact. By measuring intracardiac pressures and volumes during catheterization, researchers hope to better understand the underlying mechanisms of symptoms in this patient population.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with mitral regurgitation by clarifying the relationship between symptoms and disease severity.
How similar studies have gone: While the approach of using CMR and CPET in this context is established, the specific focus on diastolic dysfunction in relation to symptoms of mitral regurgitation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>=18 years of age * Able to give informed consent * Primary (degenerative) mitral regurgitation * LVEF \>=50% * Undergoing cardiac catheterization * Able to exercise on a treadmill Exclusion Criteria: * Unable to give informed consent * Secondary (functional) mitral regurgitation * LVEF \<50% * Known coronary artery stenosis \>=70% or past revascularization * More than mild aortic stenosis, mitral stenosis, aortic regurgitation, tricuspid regurgitation, or pulmonic regurgitation * Hypertrophic cardiomyopathy * Pregnancy
Where it's running
-
Morristown Medical Center
Morristown, New Jersey, United States Recruiting
Study contacts
- Study coordinator: Medical Director, Cardiovascular Imaging, MD
- Email: seth.uretsky@atlantichealth.org
- Phone: 9739715597
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcatheter Mitral and Tricuspid Interventions and Cardiac MRI Registry
This study will collect imaging and clinical data from adults undergoing transcatheter mitral or tricuspid procedures to see how their heart structure and function change over time using MRI and advanced ultrasound.
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Predicting afterload mismatch after transcatheter mitral edge-to-edge repair
It will test a model to predict which adults having transcatheter mitral valve edge-to-edge repair will develop afterload mismatch after the procedure.
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Evaluating a procedure for treating atrial functional mitral regurgitation
This study looks at how well a new heart procedure works for people with atrial functional mitral regurgitation to see if it helps improve their health.
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Assessing risks and outcomes in patients with mitral regurgitation
This study looks at patients with moderate to severe mitral regurgitation to see what factors might affect their health outcomes and help doctors make better treatment decisions.
-
Evaluation of the AltaValve System for treating mitral regurgitation
This study is testing a new device called the AltaValve System to see if it can help people with mitral regurgitation who can't have surgery feel better and improve their heart function.
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Using lung ultrasound to improve outcomes in cardiac surgery patients
This study is testing if using lung ultrasound can help doctors find lung problems earlier in patients after heart surgery compared to regular X-rays and CT scans.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.