Clinical trial NCT04067635: Primary Mitral Regurgitation Repair
Official title: Primary Mitral Regurgitation Reverse Remodeling
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cardiac MRI referral base, valve specialty clinic

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.

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.

Eligibility 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)

Primary outcomes:
measure: Changes in cardiomyopathy symptom score
timeFrame: Baseline, 6 (+/-3) months, >12 months
measure: Changes in distance measured on 6-Minute Walk Test
timeFrame: Baseline, 6 (+/-3) months, >12 months
Secondary outcomes:
measure: Late gadolinium myocardial enhancement
timeFrame: Baseline, 6 (+/-3) months, >12 months
measure: Myocardial extracellular volume fraction
timeFrame: Baseline, 6 (+/-3) months, >12 months
measure: Cardiac Morphology
timeFrame: Baseline, 6 (+/-3) months, >12 months
measure: Cardiovascular Flow Volumes
timeFrame: Baseline, 6 (+/-3) months, >12 months
measure: Ventricular Mass
timeFrame: Baseline, 6 (+/-3) months, >12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References: