Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

Atlantic Health System

Status: Enrolling

Conditions: Mitral Insufficiency

Treatments: Diagnostic Test: Kansas City Cardiomyopathy Questionairre; Diagnostic Test: Cardiopulmonary exercise testing (CPET); Diagnostic Test: cardiovascular magnetic resonance imaging; Diagnostic Test: Pressure volume loop evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT06738615

2223778

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

40 participants in 1 patient group

Mitral Regurgitation

Description:

Patients with mitral regurgitation undergoing a left heart catheterization prior to mitral valve surgery or mitral valve clip.

Treatment:

Diagnostic Test: Pressure volume loop evaluation

Diagnostic Test: cardiovascular magnetic resonance imaging

Diagnostic Test: Kansas City Cardiomyopathy Questionairre

Diagnostic Test: Cardiopulmonary exercise testing (CPET)