Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

NCT ID: NCT06738615

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-02

Study Completion Date

2027-05-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mitral Insufficiency

Keywords

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mitral regurgitation symptoms exercise capacity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mitral Regurgitation

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

Pressure volume loop evaluation

Intervention Type 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

Intervention Type 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)

Intervention Type DIAGNOSTIC_TEST

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

Kansas City Cardiomyopathy Questionairre

Intervention Type DIAGNOSTIC_TEST

This is a short questionnaire which objectively quantifies symptom burden

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Cardiopulmonary exercise testing (CPET)

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

Intervention Type DIAGNOSTIC_TEST

Kansas City Cardiomyopathy Questionairre

This is a short questionnaire which objectively quantifies symptom burden

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Atlantic Health System

OTHER

Sponsor Role lead

Responsible Party

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Seth Uretsky

Medical Director, Cardiovascular Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Morristown Medical Center

Morristown, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Medical Director, Cardiovascular Imaging, MD

Role: CONTACT

Phone: 9739715597

Email: [email protected]

Facility Contacts

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Kush Murkerjee, MA

Role: primary

Seth Uretsky, MD

Role: backup

Other Identifiers

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2223778

Identifier Type: -

Identifier Source: org_study_id