Mitral Valve InsufficiencyNCT04067635
Primary Mitral Regurgitation Repair
An observational study of Mitral Valve Insufficiency and Mitral Valve Prolapse, run by Eric Y. Yang, MD PhD at 1 site in United States.
Trial summary
This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Chronic Mitral Disease
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2018to Jun 2021
- 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: cardiac MRI referral base, valve specialty clinic
Who may be able to join
- Age ≥18 years
- Isolated mitral regurgitation
- of any primary mechanism and
- of moderate-to-severe (Sellers 3+) or greater severity, assessed by any imaging modality (echocardiography, angiography, cardiac MRI)
- Able to receive gadolinium-based contrast agent (estimated glomerular filtration rate >30 mL/min/1.73 m2, no prior allergy to gadolinium contrast agents)
Who cannot join
- Refusal to consent
- Pregnancy during the study
- Hemodynamically or clinically unstable
- Inability to undergo a CMR scan, which can include the following reasons: severe claustrophobia, ferromagnetic implants, implanted defibrillator, pacemaker, or abandoned pacemaker leads, cochlear implants, unable to lie flat
- Other diseases known to influence myocardial fibrosis development (coronary artery disease, diabetes mellitus, uncontrolled hypertension, infiltrative cardiomyopathy, myocarditis, hypertrophic cardiomyopathy, any cardiac tumors, moderate or more valvular heart disease other than primary mitral valve regurgitation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Mitral Regurgitation Reverse Remodeling
This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation. Participants are followed conservatively or may choose to undergo surgical repair at the discretion of their clinical team.
Read the detailed description
The transition from compensated to decompensated chronic primary mitral regurgitation remains poorly understood in the clinical setting. Changes at the myocardial tissue level, such as scar formation and decreased contractility, have been implicated in the end stage, decompensated phase of this disease entity.
Advances in cardiac MRI (CMR) have enabled non-invasive characterization of the myocardial tissue components, such as cardiomyocyte volume and extracellular matrix, and tissue contractility. These measures have been well validated in various cardiac pathologies with biopsy studies but only at single time points.
In this study, adults with isolated chronic primary regurgitation will be followed conservatively over at least a year to determine the natural progression of these CMR-derived markers over time and to investigate the prognostic potential of these markers for clinically assessed functional capacity and symptoms. These participants may elect to undergo any valvular intervention at the discretion of their treating clinical team.
Alongside this arm, similar adults with isolated chronic primary regurgitation will be recruited, who have elected upfront to undergo surgical repair. These patients will be similarly studied to determine reverse remodeling of these CMR-derived markers over time and to investigate the prognostic potential of these markers for the same clinical outcomes.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Chronic Mitral Disease, Mitral Regurgitation, Mitral Valve Disease, Degenerative Mitral Valve Disease
- Keywords
- Mitral Valve Annuloplasty, Mitral Regurgitation, Primary Mitral Regurgitation, Chronic Mitral Regurgitation, Ventricular Reverse Remodeling, Ventricular Recovery
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Arm | Participants are followed by the research team conservatively. Participants in this arm may choose to undergo any valvular intervention at the discretion of their treating clinical team. | |
| Surgical Arm | Participants have already elected upfront to undergo surgical repair (at least, mitral annuloplasty) with their treating clinical team, just prior to enrollment into this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiomyopathy symptom score
Heart failure symptom scores will be tracked to monitor for changes in symptom burden at 2 subsequent timepoints. Scores are derived from a validated cardiomyopathy symptom patient-reported outcome measure instrument. The full name of the instrument is the Kansas City Cardiomyopathy Questionnaire Short Form (aka KCCQ-12) licensed by CV Outcomes, Inc. Only a complete score is recorded. The full range of scores scale from 0 to 100, with higher scores indicating lower symptom burden.
Measured: Baseline, 6 (+/-3) months, >12 months
Changes in distance measured on 6-Minute Walk Test
Distance (meters) walked using a standardized 6-minute walk protocol will be tracked to monitor for changes in functional capacity at 2 subsequent timepoints.
Measured: Baseline, 6 (+/-3) months, >12 months
Secondary outcomes (5)
Late gadolinium myocardial enhancement
Semi-quantitative measure of left ventricular replacement fibrosis burden using cardiac MRI techniques with gadolinium-based contrast agents. The quantity measured is the percentage of left ventricular myocardial volume found to have late gadolinium enhancement.
Measured: Baseline, 6 (+/-3) months, >12 months
Myocardial extracellular volume fraction
Extracellular volume fraction measure derived using T1 mapping from cardiac MRI techniques. The quantity measured is the proportion of extracellular matrix volume to cardiomyocyte volume.
Measured: Baseline, 6 (+/-3) months, >12 months
Cardiac Morphology
Cardiac MRI measures from cine images of cardiac chamber dimensions (milliliters) at end-diastolic and end-systolic cardiac phases.
Measured: Baseline, 6 (+/-3) months, >12 months
Cardiovascular Flow Volumes
Cardiovascular MRI measures from phase contrast cine images of flow (mL/s) through major vessels. The flow quantity is integrated over a cardiac cycle to produce a volume (mL) per beat.
Measured: Baseline, 6 (+/-3) months, >12 months
Ventricular Mass
Cardiac MRI measures of left ventricular myocardial mass (grams)
Measured: Baseline, 6 (+/-3) months, >12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start25 May 2018
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eric Y. Yang, MD PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Y. Yang, MD PhD, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067635
- Sponsor's protocol ID
- Pro00018490
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Mitral Regurgitation Reverse Remodeling
- ClinicalTrials.gov ID
- NCT04067635
- Acronym / sponsor ID
- Pro00018490
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Chronic Mitral Disease, Mitral Regurgitation, Mitral Valve Disease, Degenerative Mitral Valve Disease
- Keywords
- Mitral Valve Annuloplasty, Mitral Regurgitation, Primary Mitral Regurgitation, Chronic Mitral Regurgitation, Ventricular Reverse Remodeling, Ventricular Recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Eric Y. Yang, MD PhDUniversity, hospital or other
- Study start
- 25 May 2018 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 26 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.
This longitudinal cohort study evaluates the relationship of myocardial tissue markers characteristics assessed by cardiac MRI, with clinical measures of symptoms and functions in adults with primary mitral regurgitation. Participants are followed conservatively or may choose to undergo surgical repair at the discretion of their clinical team.
Detailed description
The transition from compensated to decompensated chronic primary mitral regurgitation remains poorly understood in the clinical setting. Changes at the myocardial tissue level, such as scar formation and decreased contractility, have been implicated in the end stage, decompensated phase of this disease entity.
Advances in cardiac MRI (CMR) have enabled non-invasive characterization of the myocardial tissue components, such as cardiomyocyte volume and extracellular matrix, and tissue contractility. These measures have been well validated in various cardiac pathologies with biopsy studies but only at single time points.
In this study, adults with isolated chronic primary regurgitation will be followed conservatively over at least a year to determine the natural progression of these CMR-derived markers over time and to investigate the prognostic potential of these markers for clinically assessed functional capacity and symptoms. These participants may elect to undergo any valvular intervention at the discretion of their treating clinical team.
Alongside this arm, similar adults with isolated chronic primary regurgitation will be recruited, who have elected upfront to undergo surgical repair. These patients will be similarly studied to determine reverse remodeling of these CMR-derived markers over time and to investigate the prognostic potential of these markers for the same clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative Arm | – | –Participants are followed by the research team conservatively. Participants in this arm may choose to undergo any valvular intervention at the discretion of their treating clinical team. |
| Surgical Arm | – | –Participants have already elected upfront to undergo surgical repair (at least, mitral annuloplasty) with their treating clinical team, just prior to enrollment into this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiac MRI referral base, valve specialty clinic
Key inclusion criteria (5 listed)
- Age ≥18 years
- Isolated mitral regurgitation
- Able to receive gadolinium-based contrast agent (estimated glomerular filtration rate >30 mL/min/1.73 m2, no prior allergy to gadolinium contrast agents)
Key exclusion criteria (5 listed)
- Refusal to consent
- Pregnancy during the study
- Hemodynamically or clinically unstable
- Inability to undergo a CMR scan, which can include the following reasons: severe claustrophobia, ferromagnetic implants, implanted defibrillator, pacemaker, or abandoned pacemaker leads, cochlear implants, unable to lie flat
- Other diseases known to influence myocardial fibrosis development (coronary artery disease, diabetes mellitus, uncontrolled hypertension, infiltrative cardiomyopathy, myocarditis, hypertrophic cardiomyopathy, any cardiac tumors, moderate or more valvular heart disease other than primary mitral valve 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
Changes in cardiomyopathy symptom score
Time frame: Baseline, 6 (+/-3) months, >12 months
Heart failure symptom scores will be tracked to monitor for changes in symptom burden at 2 subsequent timepoints. Scores are derived from a validated cardiomyopathy symptom patient-reported outcome measure instrument. The full name of the instrument is the Kansas City Cardiomyopathy Questionnaire Short Form (aka KCCQ-12) licensed by CV Outcomes, Inc. Only a complete score is recorded. The full range of scores scale from 0 to 100, with higher scores indicating lower symptom burden.
Changes in distance measured on 6-Minute Walk Test
Time frame: Baseline, 6 (+/-3) months, >12 months
Distance (meters) walked using a standardized 6-minute walk protocol will be tracked to monitor for changes in functional capacity at 2 subsequent timepoints.
5 secondary outcomes
Late gadolinium myocardial enhancement
Time frame: Baseline, 6 (+/-3) months, >12 months
Myocardial extracellular volume fraction
Time frame: Baseline, 6 (+/-3) months, >12 months
Cardiac Morphology
Time frame: Baseline, 6 (+/-3) months, >12 months
Cardiovascular Flow Volumes
Time frame: Baseline, 6 (+/-3) months, >12 months
Ventricular Mass
Time frame: Baseline, 6 (+/-3) months, >12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Valve Insufficiency and Mitral Valve Prolapse, run by Eric Y. Yang, MD PhD 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 5 inclusion and 5 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 28 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiomyopathy symptom score (time frame: Baseline, 6 (+/-3) months, >12 months). The study lists 2 primary outcomes in all. 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 28 Aug 2019.