- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067635
Primary Mitral Regurgitation Repair
Primary Mitral Regurgitation Reverse Remodeling
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cardiomyopathy symptom score
Time Frame: Baseline, 6 (+/-3) months, >12 months
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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.
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Baseline, 6 (+/-3) months, >12 months
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Changes in distance measured on 6-Minute Walk Test
Time Frame: Baseline, 6 (+/-3) months, >12 months
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Distance (meters) walked using a standardized 6-minute walk protocol will be tracked to monitor for changes in functional capacity at 2 subsequent timepoints.
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Baseline, 6 (+/-3) months, >12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Late gadolinium myocardial enhancement
Time Frame: Baseline, 6 (+/-3) months, >12 months
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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.
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Baseline, 6 (+/-3) months, >12 months
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Myocardial extracellular volume fraction
Time Frame: Baseline, 6 (+/-3) months, >12 months
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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.
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Baseline, 6 (+/-3) months, >12 months
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Cardiac Morphology
Time Frame: Baseline, 6 (+/-3) months, >12 months
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Cardiac MRI measures from cine images of cardiac chamber dimensions (milliliters) at end-diastolic and end-systolic cardiac phases.
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Baseline, 6 (+/-3) months, >12 months
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Cardiovascular Flow Volumes
Time Frame: Baseline, 6 (+/-3) months, >12 months
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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.
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Baseline, 6 (+/-3) months, >12 months
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Ventricular Mass
Time Frame: Baseline, 6 (+/-3) months, >12 months
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Cardiac MRI measures of left ventricular myocardial mass (grams)
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Baseline, 6 (+/-3) months, >12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00018490
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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