Mitral InsufficiencyNCT06738615
Assessing the Relationship Between Symptoms and Mitral Regurgitnant. Severity
An observational study of Mitral Insufficiency, run by Atlantic Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mitral Insufficiency
- What is being tested?
- Pressure volume loop evaluation, cardiovascular magnetic resonance imaging and Cardiopulmonary exercise testing (CPET)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 2 May 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: This study if for patients with mitral regurgitation who are undergoing cardiac catheterization prior to mitral valve surgery or mitral valve clip.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Kush Murkerjee, MA, 9739715951, kush.mukerjee@atlantichealth.org
Seth Uretsky, MD
About this study
Official title: Assessing the Impact of Diastolic Dysfunction on the Presence of Symptoms in Patients with Primary Mitral Regurgitation.
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.
Read the 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.
- Conditions
- Mitral Insufficiency
- Being tested
- Pressure volume loop evaluation, cardiovascular magnetic resonance imaging, Cardiopulmonary exercise testing (CPET), Kansas City Cardiomyopathy Questionairre
- Keywords
- mitral regurgitation, symptoms, exercise capacity
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure volume loop evaluationDiagnostic test
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 imagingDiagnostic test
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)Diagnostic test
A CPET will be performed to objectively measure a patient ability to perform exercise.
Kansas City Cardiomyopathy QuestionairreDiagnostic test
This is a short questionnaire which objectively quantifies symptom burden
| Study group | Role | What they receive |
|---|---|---|
| Mitral Regurgitation | Patients with mitral regurgitation undergoing a left heart catheterization prior to mitral valve surgery or mitral valve clip. Receives: Diagnostic Test: Pressure volume loop evaluation; Diagnostic Test: cardiovascular magnetic resonance imaging; Diagnostic Test: Cardiopulmonary exercise testing (CPET); Diagnostic Test: Kansas City Cardiomyopathy Questionairre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diastolic Dysfunction Symptoms/exercise capacity
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).
Measured: Enrollment to testing completed 8 weeks
Secondary outcomes (1)
Mitral regurgitation severity and measures of diastolic dysfunction
MR volume and fraction compared to diastolic dysfunction as measured by pressure volume loop assessment
Measured: enrollment to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start2 Jan 2025 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Uretsky, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738615
- Sponsor's protocol ID
- 2223778
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Diastolic Dysfunction on the Presence of Symptoms in Patients with Primary Mitral Regurgitation.
- ClinicalTrials.gov ID
- NCT06738615
- Acronym / sponsor ID
- 2223778
- Conditions
- Mitral Insufficiency
- Keywords
- mitral regurgitation, symptoms, exercise capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral Regurgitation | – | Diagnostic Test: Pressure volume loop evaluation, Diagnostic Test: cardiovascular magnetic resonance imaging, Diagnostic Test: Cardiopulmonary exercise testing (CPET), Diagnostic Test: Kansas City Cardiomyopathy QuestionairrePatients with mitral regurgitation undergoing a left heart catheterization prior to mitral valve surgery or mitral valve clip. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study if for patients with mitral regurgitation who are undergoing cardiac catheterization prior to mitral valve surgery or mitral valve clip.
Key inclusion criteria (6 listed)
- Age >=18 years of age
- Able to give informed consent
- Primary (degenerative) mitral regurgitation
- LVEF >=50%
- Undergoing cardiac catheterization
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure volume loop evaluationDuring 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. | Diagnostic test | Mitral Regurgitation |
| cardiovascular magnetic resonance imagingPatients 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. | Diagnostic test | Mitral Regurgitation |
| Cardiopulmonary exercise testing (CPET)A CPET will be performed to objectively measure a patient ability to perform exercise. | Diagnostic test | Mitral Regurgitation |
| Kansas City Cardiomyopathy QuestionairreThis is a short questionnaire which objectively quantifies symptom burden | Diagnostic test | Mitral Regurgitation |
Primary outcome
Diastolic Dysfunction Symptoms/exercise capacity
Time frame: Enrollment 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).
1 secondary outcome
Mitral regurgitation severity and measures of diastolic dysfunction
Time frame: enrollment to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Insufficiency, run by Atlantic Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director, Cardiovascular Imaging, MD (9739715597, seth.uretsky@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic Dysfunction Symptoms/exercise capacity (time frame: Enrollment to testing completed 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.