Examining symptoms and severity of mitral regurgitation
Assessing the Impact of Diastolic Dysfunction on the Presence of Symptoms in Patients with Primary Mitral Regurgitation.
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 1 site (Morristown, New Jersey) |
| Trial ID | NCT06738615 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Morristown, New Jersey
- 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
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.