Recruiting

Observational Study

Sponsor:

Atlantic Health System

Code:

NCT06738615

Conditions

Mitral Insufficiency

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pressure volume loop evaluation

cardiovascular magnetic resonance imaging

Cardiopulmonary exercise testing (CPET)

Kansas City Cardiomyopathy Questionairre

Study Details

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

Study ID

NCT06738615

Start date

Jan 2, 2025

Status verified date

Dec, 2024

Completion date

May 2, 2027

Anticipated

Primary completion date

Jan 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Mitral Regurgitation

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

Interventions

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.

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.

Cardiopulmonary exercise testing (CPET)

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

Kansas City Cardiomyopathy Questionairre

This is a short questionnaire which objectively quantifies symptom burden

Primary outcome measure

  • Diastolic Dysfunction Symptoms/exercise capacity [ Time Frame: Enrollment to testing completed 8 weeks ]

Central Contacts and Locations

Central contacts

Medical Director, Cardiovascular Imaging, MD

9739715597seth.uretsky@atlantichealth.org

Locations

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Kush Murkerjee, MA

9739715951kush.mukerjee@atlantichealth.org

More Information

Sponsor

Atlantic Health System

Last update posted

Dec 17, 2024

Last verified

Dec, 2024

Keywords

  • mitral regurgitation
  • symptoms
  • exercise capacity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlantic Health System on 2024-12-17.