Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

ConditionMitral Insufficiency

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age18+

SponsorAtlantic Health System

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age >=18 years of age

Able to give informed consent

Primary (degenerative) mitral regurgitation

LVEF >=50%

Disqualifiers

Unable to give informed consent

Secondary (functional) mitral regurgitation

LVEF <50%

Known coronary artery stenosis >=70% or past revascularization

Trial population

This study if for patients with mitral regurgitation who are undergoing cardiac catheterization prior to mitral valve surgery or mitral valve clip.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Mitral Regurgitation4 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Atlantic Health System

Lead sponsor

Source ClinicalTrials.gov

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