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Primary Mitral Regurgitation Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067635
Recruitment Status : Enrolling by invitation
First Posted : August 26, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Y. Yang, MD PhD, The Methodist Hospital System

Brief 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. Participants are followed conservatively or may choose to undergo surgical repair at the discretion of their clinical team.

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

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.

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Study Type : Observational
Estimated Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Ventricular Mass [ Time Frame: Baseline, 6 (+/-3) months, >12 months ]
    Cardiac MRI measures of left ventricular myocardial mass (grams)


Biospecimen Retention:   Samples Without DNA
Whole Blood, Serum, Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
cardiac MRI referral base, valve specialty clinic
Criteria

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)

Information from the National Library of Medicine

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


Locations
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United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eric Y. Yang, MD PhD
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Responsible Party: Eric Y. Yang, MD PhD, Principal Investigator, Houston Methodist Hospital Physician, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT04067635    
Other Study ID Numbers: Pro00018490
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Y. Yang, MD PhD, The Methodist Hospital System:
Mitral Valve Annuloplasty
Mitral Regurgitation
Primary Mitral Regurgitation
Chronic Mitral Regurgitation
Ventricular Reverse Remodeling
Ventricular Recovery
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Mitral Valve Prolapse
Prolapse
Ventricular Remodeling
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Heart Valve Prolapse