Primary Mitral Regurgitation Repair

NCT ID: NCT04067635

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 116 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2021-06-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eric Y. Yang, MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Eric Y. Yang, MD PhD

Principal Investigator, Houston Methodist Hospital Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Houston Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

Pro00018490

Identifier Type: -

Identifier Source: org_study_id