RecruitingNCT06738615

Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

Assessing the Impact of Diastolic Dysfunction on the Presence of Symptoms in Patients with Primary Mitral Regurgitation.


Sponsor

Atlantic Health System

Enrollment

40 participants

Start Date

Jan 2, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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Interventions

DIAGNOSTIC_TESTPressure volume loop evaluation

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.

DIAGNOSTIC_TESTcardiovascular magnetic resonance imaging

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.

DIAGNOSTIC_TESTCardiopulmonary exercise testing (CPET)

A CPET will be performed to objectively measure a patient ability to perform exercise.

DIAGNOSTIC_TESTKansas City Cardiomyopathy Questionairre

This is a short questionnaire which objectively quantifies symptom burden


Locations(1)

Morristown Medical Center

Morristown, New Jersey, United States

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NCT06738615


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