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NCT Number: NCT06738615

Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

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.

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Key information

Conditions

Mitral Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location status: Recruiting

Location contact

Kush Murkerjee, MA

CONTACT

[email protected]

9739715951

Seth Uretsky, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Diastolic Dysfunction Symptoms/exercise capacity

    Time frame: Enrollment to testing completed 8 weeks

    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).

Secondary outcomes

  1. Mitral regurgitation severity and measures of diastolic dysfunction

    Time frame: enrollment to 8 weeks

    MR volume and fraction compared to diastolic dysfunction as measured by pressure volume loop assessment

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director, Cardiovascular Imaging, MD

CONTACT

[email protected]

9739715597

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Official study title

Assessing the Impact of Diastolic Dysfunction on the Presence of Symptoms in Patients with Primary Mitral Regurgitation.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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