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Observational Study on Mitral Regurgitation Symptoms and Severity

This study is looking at the connection between symptoms and how severe mitral regurgitation (a heart valve problem) is. Researchers want to understand why some people with severe mitral regurgitation don't have many symptoms, while others do. You might be able to join if you are at least 18 years old, have primary mitral regurgitation, and are having a cardiac catheterization. The study will use tests like cardiovascular magnetic resonance imaging (CMR) to measure your heart, cardiopulmonary exercise testing (CPET) to check your exercise ability, and a Kansas City Cardiomyopathy Questionnaire (KCCQ) to assess your symptoms. They will also use a special catheter during your heart catheterization to measure pressures in your heart. The main goal is to see how your symptoms and exercise ability relate to these measurements. The current status of this study is unclear.

Study design
This is an observational study involving 40 participants. It is not testing a new treatment but rather observing patients undergoing standard procedures.
What's involved
You would undergo cardiovascular magnetic resonance imaging (CMR), cardiopulmonary exercise testing (CPET), and complete a Kansas City Cardiomyopathy Questionnaire (KCCQ) before your left heart catheterization (LHC). During the LHC, an additional specialized catheter will be used.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms and exercise capacity will be measured from enrollment until testing is completed, which is within 8 weeks.

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NCT06738615

Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

Recruiting
Not specifiedAges 18+Observational
Atlantic Health System
~40 participants
Updated 2024-12-17 on ClinicalTrials.gov
What's tested:Pressure volume loop evaluationcardiovascular magnetic resonance imagingCardiopulmonary exercise testing (CPET)Kansas City Cardiomyopathy Questionairre

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diastolic Dysfunction Symptoms/exercise capacity
Measured over Enrollment to testing completed 8 weeks

Conditions

Mitral Insufficiency

Explore related trials

Mitral Valve Insufficiency

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Medical Director, Cardiovascular Imaging, MD
[email protected]
9739715597
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Diastolic Dysfunction Symptoms/exercise capacityEnrollment 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).