Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

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 typeObservational
Ages18 Years and up
SexMen only
Enrollment40 (estimated)
SponsorAtlantic Health System
Academic / other
Locations1 site (Morristown, New Jersey)
StatusRecruiting
StartedJanuary 2, 2025
Main results expectedJanuary 2, 2027
Study endsMay 2, 2027
Registry record updatedDecember 17, 2024
Trial IDNCT06738615 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.