Mitral RegurgitationNCT04051411
The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity
An observational study of Mitral Regurgitation, run by Atlantic Health System at 1 site in United States.
Trial summary
Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2019to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with moderate or severe mitral regurgitation by echocardiography and remain asymptomatic
Who may be able to join
- Age >=18 yrs
- able to give informed consent
- Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography)
Who cannot join
- Left ventricular ejection fraction <60%
- Heart failure
- Pulmonary hypertension (pulmonary artery systolic pressure >40mmHg at rest or >60mmHg with exercise as assessed by echocardiography)
- Atrial fibrillation
- Concomitant > mild aortic or mitral stenosis, >mild aortic or tricuspid or pulmonic regurgitation
- Prior valvular heart disease surgery
Show all 11Show fewer
- Hypertrophic cardiomyopathy or an infiltrative cardiomyopathy
- Unable to exercise on a treadmill
- Symptomatic coronary artery disease
- Comorbidities expected to impact functional capacity and confound symptom assessment (e.g COPD)
- Expected lifespan of less than 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Seth Uretsky, MD, 973-971-5597, seth.uretsky@atlantichealth.org
Susan Miller, RN, 9739715597, susan.miller@atlantichealth.org
About this study
Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
Read the detailed description
Current ACC/AHA guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. There are those who advocate for performing early "prophylactic" mitral valve surgery while others advocate clinical follow-up until triggers emerge with echocardiography historically being the method used for longitudinal assessment of cardiac anatomy and function. Two studies showed that only ~30% of asymptomatic severe mitral regurgitation made endpoints that triggered. However, these studies were limited and did not perform rigorous follow up assessment of regurgitant volume, left ventricular hemodynamics, exercise capacity, or quality of life assessment. In addition, in these studies mitral regurgitation and left ventricular size and function was assessed by echocardiography. Echocardiography has known limitations in assessing ventricular size and, as recent studies have shown, may not be the optimal modality to assess mitral regurgitant severity. MRI is the gold standard for non-invasive quantification of the left and right ventricles volumes and function and has emerged as a reference standard for quantifying mitral regurgitation. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, echocardiography, MRI
- Medical subject headings
- Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mitral regurgitant volume
Change in mitral regurgitant volume quantified by MRI over follow-up period
Measured: Entry into study, 1 year, and 2 years
Secondary outcomes (5)
Change in left ventricular end-diastolic volume
Change in left ventricular end-diastolic volume quantified by MRI over follow-up period
Measured: Entry into study, 1 year, and 2 years
Change in symptoms and quality
Change in symptoms and quality of life as measured by EQ5DL questionnaires
Measured: Entry into study, 1 year, and 2 years
Change in exercise capacity
Change in exercise capacity measured by treadmill exercise test
Measured: Entry into study, 1 year, and 2 years
Follow up events
Follow up events defined as death, need for surgery, heart failure symptoms, or valvular disease related hospitalizations
Measured: 1 yea, and 2 years
Change in degree of myocardial fibrosis
Change in degree of myocardial fibrosis measured as the percentage left ventricular hyperenhancement and change in mean ECV
Measured: Entry into study, 1 year, and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start7 Aug 2019
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies 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
- 30 participants (estimated)
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
- NCT04051411
- Sponsor's protocol ID
- 1444724
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Uretsky S, Gillam LD, Biederman RWW, Han Y, Jacob R, Martin ET, Langer M, Choi AD, Sultan I, Cavalcante JL, Shah DJ, Tong MS, Wolff SD, Sakul S, Guglielmo M, Pontone G. Sex differences in pre- and post-surgical left ventricular remodelling and outcomes in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1429-1437. doi: 10.1093/ehjci/jeaf151.
PubMed 40392571
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Degenerative Mitral Regurgitation on Cardiac Structure and Function, Symptoms, and Exercise Capacity
- ClinicalTrials.gov ID
- NCT04051411
- Acronym / sponsor ID
- 1444724
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, echocardiography, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 9 Aug 2019 (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.
Current American College of Cardiology/American Heart Association guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
Detailed description
Current ACC/AHA guidelines recommend that patients with severe degenerative mitral regurgitation be considered for mitral valve surgery. There remains a debate within the cardiology community regarding the appropriate management of patients who remain asymptomatic. There are those who advocate for performing early "prophylactic" mitral valve surgery while others advocate clinical follow-up until triggers emerge with echocardiography historically being the method used for longitudinal assessment of cardiac anatomy and function. Two studies showed that only ~30% of asymptomatic severe mitral regurgitation made endpoints that triggered. However, these studies were limited and did not perform rigorous follow up assessment of regurgitant volume, left ventricular hemodynamics, exercise capacity, or quality of life assessment. In addition, in these studies mitral regurgitation and left ventricular size and function was assessed by echocardiography. Echocardiography has known limitations in assessing ventricular size and, as recent studies have shown, may not be the optimal modality to assess mitral regurgitant severity. MRI is the gold standard for non-invasive quantification of the left and right ventricles volumes and function and has emerged as a reference standard for quantifying mitral regurgitation. In this study the investigators will perform longitudinal follow-up data with cardiac MRI to inform the prophylactic surgery vs. close follow-up debate and to better define the natural history of this condition. The investigators hypothesize, that in the majority of patients mitral regurgitation will not worsen overtime, left ventricular hemodynamics will remain stable, exercise capacity will not decline, and symptoms will not worsen during follow-up. This finding would have a significant impact on the current recommendations for treatment in patients with mitral regurgitation by supporting a conservative management approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with moderate or severe mitral regurgitation by echocardiography and remain asymptomatic
Key inclusion criteria (3 listed)
- Age >=18 yrs
- able to give informed consent
- Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography)
Key exclusion criteria (11 listed)
- Left ventricular ejection fraction <60%
- Heart failure
- Pulmonary hypertension (pulmonary artery systolic pressure >40mmHg at rest or >60mmHg with exercise as assessed by echocardiography)
- Atrial fibrillation
- Concomitant > mild aortic or mitral stenosis, >mild aortic or tricuspid 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.
Primary outcome
Change in mitral regurgitant volume
Time frame: Entry into study, 1 year, and 2 years
Change in mitral regurgitant volume quantified by MRI over follow-up period
5 secondary outcomes
Change in left ventricular end-diastolic volume
Time frame: Entry into study, 1 year, and 2 years
Change in symptoms and quality
Time frame: Entry into study, 1 year, and 2 years
Change in exercise capacity
Time frame: Entry into study, 1 year, and 2 years
Follow up events
Time frame: 1 yea, and 2 years
Change in degree of myocardial fibrosis
Time frame: Entry into study, 1 year, and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Derived from this study: PubMed 40392571Uretsky S, Gillam LD, Biederman RWW, Han Y, Jacob R, Martin ET, Langer M, Choi AD, Sultan I, Cavalcante JL, Shah DJ, Tong MS, Wolff SD, Sakul S, Guglielmo M, Pontone G. Sex differences in pre- and post-surgical left ventricular remodelling and outcomes in primary mitral regurgitation. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1429-1437. doi: 10.1093/ehjci/jeaf151.
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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. This study is not recruiting at the moment.
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 Regurgitation, 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SETH URETSKY, MD (9739715597, seth.uretsky@atlantichealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mitral regurgitant volume (time frame: Entry into study, 1 year, and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04051411, which also lists 1 linked publication.
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 21 Aug 2019.