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Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06738615
Enrollment
40
Registered
2024-12-17
Start date
2025-01-02
Completion date
2027-05-02
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Insufficiency

Keywords

mitral regurgitation, symptoms, exercise capacity

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.

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_TESTPressure 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.

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.

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

DIAGNOSTIC_TESTKansas City Cardiomyopathy Questionairre

This is a short questionnaire which objectively quantifies symptom burden

Sponsors

Atlantic Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diastolic Dysfunction Symptoms/exercise capacityEnrollment to testing completed 8 weeksAssess 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).

Secondary

MeasureTime frameDescription
Mitral regurgitation severity and measures of diastolic dysfunctionenrollment to 8 weeksMR volume and fraction compared to diastolic dysfunction as measured by pressure volume loop assessment

Countries

United States

Contacts

Primary ContactMedical Director, Cardiovascular Imaging, MD
seth.uretsky@atlantichealth.org9739715597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026