Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

NCT06738615 | Recruiting

• 1 other identifier: 2223778
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mitral regurgitation; symptoms; exercise capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mitral regurgitation severity and measures of diastolic dysfunction

  enrollment to 8 weeks

Study Arms (1)

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; Diagnostic Test: cardiovascular magnetic resonance imaging; Diagnostic Test: Cardiopulmonary exercise testing (CPET); Diagnostic Test: Kansas City Cardiomyopathy Questionairre

Interventions

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.

Mitral Regurgitation

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.

Mitral Regurgitation

Cardiopulmonary exercise testing (CPET) DIAGNOSTIC_TEST

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

Mitral Regurgitation

Kansas City Cardiomyopathy Questionairre DIAGNOSTIC_TEST

This is a short questionnaire which objectively quantifies symptom burden

Mitral Regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlantic Health System: lead

Study Sites (1)

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Medical Director, Cardiovascular Imaging, MD

CONTACT

9739715597; seth.uretsky@atlantichealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Cardiovascular Imaging

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 17, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): May 2, 2027
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

US (1)