An observational study in Mitral Insufficiency, sponsored by Atlantic Health System. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Atlantic Health System · Observational
The current American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend surgery in patient with mitral regurgitation (MR) based on 1) the severity of MR and 2) the presence or absence of symptoms. Studies have shown that Cardiovascular Magnetic Resonance (CMR) is an accurate method to quantify the severity of MR. However, studies have also shown that symptoms are not necessarily related to the presence of symptoms. Thus, there appears to be a disconnect between the severity of MR and symptoms. Recent analysis of our data has shown that females and older patients with smaller ventricles, lower stroke volumes, and lower regurgitant volume relative to regurgitant fraction tend to be symptomatic. These findings suggest that decreased left ventricular compliance, i.e. diastolic dysfunction, may play an important role as an etiology of symptoms in patients with mitral regurgitation. The aim of this study is to study the presence of diastolic dysfunction in patients with MR and its association with symptom burden and exercise capacity.
The study is an observational study of patients with mitral regurgitation undergoing LHC prior to mitral valve surgery or percutaneous mitral valve intervention. Prior to patients LHC they will undergo testing using CMR, CPET, and KCCQ. During the LHC, patients will undergo evaluation of intracardiac pressures and volumes using a specialized catheter which measures pressure and volume changes throughout the cardiac cycle.
CMR- CMR evaluation will quantify mitral regurgitant volume and fraction, right and left atrial size and function, and myocardial scar quantification.
CPET- objectively assess patients exercise capacity. KCCQ- is a standard questionnaire designed to assesses patients quality of life and symptom burden.
LHC- Pressure-volume loops will be measured during LHC. This will quantify left ventricular compliance and assess patients for the presence of diastolic dysfunction.
These evaluations will help us better understand the relationship between symptoms, exercise capacity, severity of MR and diastolic dysfunction.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's planned enrollment of 40 is below the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Atlantic Health System is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
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This study if for patients with mitral regurgitation who are undergoing cardiac catheterization prior to mitral valve surgery or mitral valve clip.
Exclusion Criteria:
Patients with mitral regurgitation undergoing a left heart catheterization prior to mitral valve surgery or mitral valve clip.
Diagnostic Test: Pressure volume loop evaluation · Diagnostic Test: cardiovascular magnetic resonance imaging · Diagnostic Test: Cardiopulmonary exercise testing (CPET) · Diagnostic Test: Kansas City Cardiomyopathy Questionairre
During the left heart catheterization there are catheters which are introduced into the left ventricle to measure left ventricular pressures and into the coronary arteries to assess their patency. This study will require the placement of an additional specialized catheter made into the left ventricle to measure the change of pressure and volume during the cardiac cycle. This will allow the measurement of heart muscle stiffness.
Patients will undergo standard cardiovascular magnetic resonance imaging of their heart to measure their heart size, heart function, and severity of mitral regurgitation. In addition, contrast will be administered and heart tissue will be assessed for scarring or fibrosis.
A CPET will be performed to objectively measure a patient ability to perform exercise.
This is a short questionnaire which objectively quantifies symptom burden
Diastolic Dysfunction Symptoms/exercise capacity
Assess the relationship between diastolic dysfunction. Diastolic dysfunction is measured by pressure volume loop assessment. Diastolic disfunction will be compared to patients symptom burden (as quantified by KCCQ) and exercise capacity (as quantified by CPET).
Time frame: Enrollment to testing completed 8 weeks
Mitral regurgitation severity and measures of diastolic dysfunction
MR volume and fraction compared to diastolic dysfunction as measured by pressure volume loop assessment
Time frame: enrollment to 8 weeks
Plan to share: Undecided
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