Actively Recruiting
Assessing the Impact of Diastolic Dysfunction on Symptoms in Patients with Primary Mitral Regurgitation
Led by Atlantic Health System · Updated on 2024-12-17
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study patients with primary mitral regurgitation (MR) to understand how diastolic dysfunction, or decreased left ventricular compliance, relates to symptom burden and exercise capacity. Current guidelines recommend surgery based on MR severity and symptoms, but symptoms do not always correlate with severity. This study explores this disconnect, especially noting differences in females and older patients with certain heart characteristics. Participants with MR preparing for mitral valve surgery or percutaneous intervention will undergo several tests. These include cardiovascular magnetic resonance imaging (CMR) to measure heart size, function, and scarring; cardiopulmonary exercise testing (CPET) to assess exercise capacity; and the Kansas City Cardiomyopathy Questionnaire (KCCQ) to evaluate quality of life and symptom burden. During left heart catheterization (LHC), a specialized catheter will measure pressure and volume changes to assess left ventricular stiffness and diastolic dysfunction. Participants will be observed from enrollment through testing over eight weeks. Researchers will collect data on symptoms, exercise capacity, MR severity, and diastolic function. The study involves detailed heart imaging, exercise testing, questionnaires, and invasive pressure-volume measurements during LHC. These assessments will help clarify the relationship between symptoms, heart function, and MR severity, improving understanding of the condition.
CONDITIONS
Brief Title
Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to give informed consent
- Primary (degenerative) mitral regurgitation
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Undergoing cardiac catheterization
- Able to exercise on a treadmill
You will not qualify if you...
- Unable to give informed consent
- Secondary (functional) mitral regurgitation
- Left ventricular ejection fraction (LVEF) below 50%
- Known coronary artery stenosis of 70% or greater or past revascularization
- More than mild aortic stenosis, mitral stenosis, aortic regurgitation, tricuspid regurgitation, or pulmonic regurgitation
- Hypertrophic cardiomyopathy
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 weeks from enrollment to testing completion
Participants undergo cardiovascular magnetic resonance imaging (CMR), cardiopulmonary exercise testing (CPET), and complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess heart function, exercise capacity, and symptom burden before catheterization.
1 to 3 visits depending on testing schedule
Duration - Single day procedure during catheterization visit
During left heart catheterization (LHC), participants have specialized catheters placed to measure left ventricular pressures and volumes throughout the cardiac cycle to evaluate heart muscle stiffness and diastolic dysfunction.
1 visit (in-person) for left heart catheterization
Trial Site Locations
Total: 1 location
1
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
Research Team
M
Medical Director, Cardiovascular Imaging, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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