Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
NCT ID: NCT06738615
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2025-01-02
2027-05-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mitral Regurgitation
Patients with mitral regurgitation undergoing a left heart catheterization prior to mitral valve surgery or mitral valve clip.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent
* Primary (degenerative) mitral regurgitation
* LVEF \>=50%
* Undergoing cardiac catheterization
* Able to exercise on a treadmill
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Atlantic Health System
OTHER
Responsible Party
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Seth Uretsky
Medical Director, Cardiovascular Imaging
Locations
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Morristown Medical Center
Morristown, New Jersey, United States
Countries
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Central Contacts
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Medical Director, Cardiovascular Imaging, MD
Role: CONTACT
Phone: 9739715597
Email: [email protected]
Facility Contacts
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Kush Murkerjee, MA
Role: primary
Seth Uretsky, MD
Role: backup
Other Identifiers
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2223778
Identifier Type: -
Identifier Source: org_study_id