Primary Mitral Regurgitation Repair

NCT04067635 | Unknown

• 1 other identifier: Pro00018490
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Insufficiency; Mitral Valve Prolapse; Chronic Mitral Disease; Mitral Regurgitation; Mitral Valve Disease; Degenerative Mitral Valve Disease; Myxomatous Mitral Valve Degeneration; Ventricular Remodeling

Keywords

Mitral Valve Annuloplasty; Mitral Regurgitation; Primary Mitral Regurgitation; Chronic Mitral Regurgitation; Ventricular Reverse Remodeling; Ventricular Recovery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Late gadolinium myocardial enhancement

  Baseline, 6 (+/-3) months, >12 months

• Myocardial extracellular volume fraction

  Baseline, 6 (+/-3) months, >12 months

• Cardiac Morphology

  Baseline, 6 (+/-3) months, >12 months

• Cardiovascular Flow Volumes

  Baseline, 6 (+/-3) months, >12 months

• Ventricular Mass

  Baseline, 6 (+/-3) months, >12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

cardiac MRI referral base, valve specialty clinic

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eric Y. Yang, MD PhD: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole Blood, Serum, Plasma

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Prolapse; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Valve Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Houston Methodist Hospital Physician

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: May 25, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)