Mitral Regurgitation Clinical Trial
Official title:
Primary Mitral Regurgitation Reverse Remodeling
Verified date | August 2019 |
Source | The Methodist Hospital System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 116 |
Est. completion date | June 2021 |
Est. primary completion date | June 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age =18 years 2. Isolated mitral regurgitation 1. of any primary mechanism and 2. of moderate-to-severe (Sellers 3+) or greater severity, assessed by any imaging modality (echocardiography, angiography, cardiac MRI) 3. 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: 1. Refusal to consent 2. Pregnancy during the study 3. Hemodynamically or clinically unstable 4. 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 5. 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) |
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Eric Y. Yang, MD PhD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 6 (+/-3) months, >12 months | |
Primary | 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. | Baseline, 6 (+/-3) months, >12 months | |
Secondary | 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. | Baseline, 6 (+/-3) months, >12 months | |
Secondary | 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. | Baseline, 6 (+/-3) months, >12 months | |
Secondary | Cardiac Morphology | Cardiac MRI measures from cine images of cardiac chamber dimensions (milliliters) at end-diastolic and end-systolic cardiac phases. | Baseline, 6 (+/-3) months, >12 months | |
Secondary | 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. | Baseline, 6 (+/-3) months, >12 months | |
Secondary | Ventricular Mass | Cardiac MRI measures of left ventricular myocardial mass (grams) | Baseline, 6 (+/-3) months, >12 months |
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