Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Atlantic Health System
Study ID
NCT06738615
Status
Recruiting
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Conditions

  • Mitral Insufficiency

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pressure volume loop evaluation — DIAGNOSTIC_TEST
    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.
  • cardiovascular magnetic resonance imaging — DIAGNOSTIC_TEST
    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.
  • Cardiopulmonary exercise testing (CPET) — DIAGNOSTIC_TEST
    A CPET will be performed to objectively measure a patient ability to perform exercise.
  • Kansas City Cardiomyopathy Questionairre — DIAGNOSTIC_TEST
    This is a short questionnaire which objectively quantifies symptom burden

Study Details

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.

Key Dates

Start date
Jan 2, 2025
Status verified
Dec 2024
Primary completion
Jan 2, 2027
Completion
May 2, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Mitral Regurgitation
    Patients with mitral regurgitation undergoing a left heart catheterization prior to mitral valve surgery or mitral valve clip.

Primary Outcome Measure

Diastolic Dysfunction Symptoms/exercise capacity [ Time Frame: Enrollment to testing completed 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Morristown Medical CenterMorristownNew Jersey07960
Kush Murkerjee, MA
[email protected]
9739715951
Seth Uretsky, MD

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Morristown Medical Center· Morristown, NJ

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