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.

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Insufficiency
• Intervention / Treatment: Diagnostic test: Pressure volume loop evaluation; Diagnostic test: cardiovascular magnetic resonance imaging; Diagnostic test: Cardiopulmonary exercise testing (CPET); Diagnostic test: Kansas City Cardiomyopathy Questionairre

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Medical Director, Cardiovascular Imaging, MD; Phone Number: 9739715597; Email: seth.uretsky@atlantichealth.org

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Morristown Medical Center
      • Contact: Kush Murkerjee, MA; Phone Number: 9739715951; Email: kush.mukerjee@atlantichealth.org
      • Contact: Seth Uretsky, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Enrollment to testing completed 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitral regurgitation severity and measures of diastolic dysfunction	MR volume and fraction compared to diastolic dysfunction as measured by pressure volume loop assessment	enrollment to 8 weeks

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2025
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): May 2, 2027

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: exercise capacity; mitral regurgitation; symptoms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2223778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No