Primary Mitral Regurgitation Repair
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|ClinicalTrials.gov Identifier: NCT04067635|
Recruitment Status : Enrolling by invitation
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
|Condition or disease|
|Mitral Valve Insufficiency Mitral Valve Prolapse Chronic Mitral Disease Mitral Regurgitation Mitral Valve Disease Degenerative Mitral Valve Disease Myxomatous Mitral Valve Degeneration Ventricular Remodeling|
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 :||Observational|
|Estimated Enrollment :||116 participants|
|Official Title:||Primary Mitral Regurgitation Reverse Remodeling|
|Actual Study Start Date :||May 25, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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.
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.
- 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.
- Late gadolinium myocardial enhancement [ Time Frame: Baseline, 6 (+/-3) months, >12 months ]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.
- Myocardial extracellular volume fraction [ Time Frame: Baseline, 6 (+/-3) months, >12 months ]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.
- Cardiac Morphology [ Time Frame: Baseline, 6 (+/-3) months, >12 months ]Cardiac MRI measures from cine images of cardiac chamber dimensions (milliliters) at end-diastolic and end-systolic cardiac phases.
- Cardiovascular Flow Volumes [ Time Frame: Baseline, 6 (+/-3) months, >12 months ]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.
- Ventricular Mass [ Time Frame: Baseline, 6 (+/-3) months, >12 months ]Cardiac MRI measures of left ventricular myocardial mass (grams)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067635
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|