Primary Mitral Regurgitation Repair

Mitral Regurgitation Clinical Trial

Official title:

Primary Mitral Regurgitation Reverse Remodeling

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04067635
• Other study ID #: Pro00018490
• Status: Enrolling by invitation
• Start date: May 25, 2018
• Est. completion date: June 2021

Study information

• Verified date: August 2019
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Chronic Mitral Disease
• Degenerative Mitral Valve Disease
• Heart Valve Diseases
• Mitral Regurgitation
• Mitral Valve Disease
• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Myxomatous Mitral Valve Degeneration
• Prolapse
• Ventricular Remodeling

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eric Y. Yang, MD PhD

Country where clinical trial is conducted

United States, 

Outcome

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