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Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

NCT06738615 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-12-17

No results posted yet for this study

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.

Conditions

  • Mitral Insufficiency

Interventions

DIAGNOSTIC_TEST

Pressure 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_TEST

cardiovascular 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_TEST

Cardiopulmonary exercise testing (CPET)

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

DIAGNOSTIC_TEST

Kansas City Cardiomyopathy Questionairre

This is a short questionnaire which objectively quantifies symptom burden

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2027-01-02
Completion
2027-05-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06738615 on ClinicalTrials.gov