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Recruiting NCT06738615

Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

— Observational Mitral Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pressure volume loop evaluation, cardiovascular magnetic resonance imaging, Cardiopulmonary exercise testing (CPET), Kansas City Cardiomyopathy Questionairre.
Who it may be relevant to
Registry conditions: Mitral Insufficiency. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • 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

Primary outcome measures

  • Diastolic Dysfunction Symptoms/exercise capacity [Time frame: Enrollment to testing completed 8 weeks]
Secondary outcome measures (1)
  • Mitral regurgitation severity and measures of diastolic dysfunction [Time frame: enrollment to 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Morristown Medical Center — Morristown

Identifiers

NCT: NCT06738615 · 2223778

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗